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Drug recalls

Enforcement reports from the FDA's weekly recall database. Recalls are classified by the health hazard the defect presents: Class I where exposure is reasonably likely to cause serious harm or death, Class II where it may cause temporary or reversible harm, and Class III where it is unlikely to cause harm.

17,975 records · source: openFDA Enforcement

All classes 17,975 Class II 14,511 Class I 1,747 Class III 1,715 Not Yet Classified 2
Most recent recall enforcement reports first.
Class Reported Product Reason Firm Status
Class II December 11, 2013 Marcaine .1%/NS 450ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern,… The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded… Main Street Family Pharmacy, LLC Terminated
Class II December 11, 2013 Testosterone Pellet 87.5mg, Main Street Compounding Pharmacy, 126 East Main Street,… The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded… Main Street Family Pharmacy, LLC Terminated
Class II December 11, 2013 Testosterone Pellet 112.5mg, Main Street Compounding Pharmacy, 126 East Main Street,… The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded… Main Street Family Pharmacy, LLC Terminated
Class II December 11, 2013 Lipo X 50ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059,… The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded… Main Street Family Pharmacy, LLC Terminated
Class II December 11, 2013 Marcaine .1% NS 300ml pump, Main Street Compounding Pharmacy, 126 East Main Street,… The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded… Main Street Family Pharmacy, LLC Terminated
Class II December 11, 2013 Phosphatidylcholine/Deoxycholic Acid 50ml, Main Street Compounding Pharmacy, 126 East… The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded… Main Street Family Pharmacy, LLC Terminated
Class II December 11, 2013 Tetracaine 2%, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059,… The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded… Main Street Family Pharmacy, LLC Terminated
Class II December 11, 2013 HCG 210 iu prefilled syringes, Main Street Compounding Pharmacy, 126 East Main Street,… The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded… Main Street Family Pharmacy, LLC Terminated
Class II December 11, 2013 Lidocaine 1% 30ml (PF), Main Street Compounding Pharmacy, 126 East Main Street, Newbern,… The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded… Main Street Family Pharmacy, LLC Terminated
Class II December 11, 2013 HCG 250 iu prefilled syringes, Main Street Compounding Pharmacy, 126 East Main Street,… The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded… Main Street Family Pharmacy, LLC Terminated
Class II December 11, 2013 Lido 2% MPF 2ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN… The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded… Main Street Family Pharmacy, LLC Terminated
Class II December 11, 2013 Testosterone Pellet 12.5mg, Main Street Compounding Pharmacy, 126 East Main Street,… The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded… Main Street Family Pharmacy, LLC Terminated
Class II December 11, 2013 Mic Ultra 10ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN… The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded… Main Street Family Pharmacy, LLC Terminated
Class II December 11, 2013 Triamcinolone Acetonide 40mg/ml, Main Street Compounding Pharmacy, 126 East Main Street,… The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded… Main Street Family Pharmacy, LLC Terminated
Class II December 11, 2013 Triamcinolone 40mg PF 10ml, Main Street Compounding Pharmacy, 126 East Main Street,… The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded… Main Street Family Pharmacy, LLC Terminated
Class II December 11, 2013 Testosterone Cypionate w/lidocaine 10ml, Main Street Compounding Pharmacy, 126 East Main… The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded… Main Street Family Pharmacy, LLC Terminated
Class II December 11, 2013 Estradiol Pellet 37.5mg, Main Street Compounding Pharmacy, 126 East Main Street, Newbern,… The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded… Main Street Family Pharmacy, LLC Terminated
Class II December 11, 2013 TCA 30% 30ml vial, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN… The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded… Main Street Family Pharmacy, LLC Terminated
Class II December 11, 2013 Marcaine .1%/NS 400ml-pump, Main Street Compounding Pharmacy, 126 East Main Street,… The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded… Main Street Family Pharmacy, LLC Terminated
Class II December 11, 2013 EDTA 150mg/ml 100ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN… The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded… Main Street Family Pharmacy, LLC Terminated
Class II December 11, 2013 Lipotropic 30ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN… The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded… Main Street Family Pharmacy, LLC Terminated
Class II December 11, 2013 Mesotherapy, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059,… The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded… Main Street Family Pharmacy, LLC Terminated
Class II December 11, 2013 Morphine Sulfate Injection, USP, (25mg/mL), 250 mg, 10mL Fill, Single dosage Flip top… Lack of Assurance of Sterility: Confirmed customer report of leakage of vial contents due to the breaking of the vial… Hospira, Inc. Terminated
Class I December 4, 2013 J.R. Jack Rabbit All Natural Herbal Supplement, One tablet can last 24-72 hours, 4-count… Marketed without an Approved NDA/ANDA: Laboratory analysis conducted by the FDA has determined that J.R. Jack Rabbit… Jack Rabbit, Inc Terminated
Class III December 4, 2013 Loratadine, USP 10 mg, Antihistamine, packaged in blister packs. All manufactured by… Failed Tablet/Capsule Specifications: The products are being recalled due to chipped and broken tablets. Novartis Consumer Health Terminated
Class III December 4, 2013 Acanya (Clindamycin Phosphate and Benzoyl Peroxide) Gel 1.2% and 2.5%, Net Wt. 3.5 g, Rx… Labeling: Incorrect or Missing Lot and/or Exp Date: This recall is being carried out due to an incorrect expiration… Valeant Pharmaceuticals North Am Terminated
Class III December 4, 2013 Paclitaxel PACLITAXEL INJECTION, USP (semisynthetic); 300 mg/50 mL; (6 mg/mL); Multiple Dose… Labeling: Incorrect or Missing Package Insert- Missing text on the product insert in the "Clinical Studies" and… Fresenius Kabi USA, LLC Terminated
Class II December 4, 2013 Acyclovir Acyclovir Tablets USP 800 mg ,(NDC 60505-5307-1), Rx only, Manufactured by Apotex Inc.,… Presence of Particulate Matter: Product from lot KF2199, may contain tablets with pieces of nitrile rubber glove… Apotex Inc. Terminated
Class II December 4, 2013 Alprazolam Alprazolam Orally Disintegrating Tablets, USP 2 mg, 100 count bottles, Rx Only, MFG. BY… Failed Tablet/Capsule Specifications; partial tablet erosion resulting in tablet weights below specification in some… Actavis Elizabeth LLC Terminated
Class II December 4, 2013 Cetacaine Liquid Topical Anesthetic, Rx Only, a) 14 g bottle (NDC 10223-0202-2); Kit w/14… Subpotent Drug: Cetacaine Topical Anesthetic Liquid is being recalled because one of the three active ingredients,… Cetylite Industries, Inc. Terminated
Class II November 27, 2013 Spironolactone tablets, USP 50 mg, Rx only, 100 count bottle, Distributed By: Greenstone… Marketed without an Approved NDA/ANDA: This recall is being initiated because of changes to the dissolution profile in… Greenstone Llc Terminated
Class II November 27, 2013 Spironolactone tablets, USP 25 mg, Rx only, 500 count bottle, Distributed By: Greenstone… Marketed without an Approved NDA/ANDA: This recall is being initiated because of changes to the dissolution profile in… Greenstone Llc Terminated
Class III November 27, 2013 Derma-Smoothe/FS (fluocinolone acetonide) 0.01% Topical Oil (Body Oil), 118.28 mL (4 fl.… Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine… Hill Dermaceuticals, Inc. Terminated
Class I November 27, 2013 Affirm XL Nutritional Supplement, 1 and 10 count blister packs and single pill packs,… Marketed Without An Approved NDA/ANDA: FDA analysis found the product to contain sulfoaildenafil, an analogue of… Affirm XL, Inc. Terminated
Class III November 27, 2013 Derma-Smoothe/FS (fluocinolone acetonide) 0.01% Topical Oil (Scalp Oil), 118.28 mL (4 Fl.… Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine… Hill Dermaceuticals, Inc. Terminated
Class II November 27, 2013 Omeprazole Omeprazole Delayed-Release Capsules, USP, 20 mg, Rx Only, 1000 Capsules per bottle,… Failed Tablet/Capsule Specification: some capsules over time do not meet or are suspected to not meet the specification… Kremers Urban Pharmaceuticals, Inc. Terminated
Class II November 27, 2013 Acetaminophen suspension liquid, 160 mg/5 mL, grape flavor, 2 FL OZ (59 mL) bottle… Defective Delivery System: There is a remote potential that cartons of product could be co-packaged with an oral dosing… L. Perrigo Co. Terminated
Class II November 27, 2013 Acetaminophen suspension liquid, 160 mg/5 mL, dye-free cherry flavor, co-packaged with an… Defective Delivery System: There is a remote potential that cartons of product could be co-packaged with an oral dosing… L. Perrigo Co. Terminated
Class II November 27, 2013 Acetaminophen suspension liquid, 160 mg/5 mL, dye-free grape flavor, 2 FL OZ (59 mL)… Defective Delivery System: There is a remote potential that cartons of product could be co-packaged with an oral dosing… L. Perrigo Co. Terminated
Class II November 27, 2013 Acetaminophen suspension liquid, 160 mg/5 mL, cherry flavor, 2 FL OZ (59 mL) bottle… Defective Delivery System: There is a remote potential that cartons of product could be co-packaged with an oral dosing… L. Perrigo Co. Terminated
Class II November 27, 2013 Oxcarbazepine Oral Suspension, 300 mg/5 mL, 250 mL bottle, Rx only, Boehringer Ingelheim,… Resuspension Problems: Recalled lot did not meet resuspendability requirements. Boehringer Ingelheim Roxane Inc Terminated
Class II November 27, 2013 Aldactone Aldactone (spironolactone) tablets, USP, 100 mg, 100-count bottles, Rx only, Distributed… Marketed without an Approved NDA/ANDA: This recall is being initiated because of changes to the dissolution profile in… Pfizer Us Pharmaceutical Group Terminated
Class II November 27, 2013 metoclopramide Metoclopramide Injection, USP 10 mg (5mg/mL), 2 mL Single-dose Vial, Rx Only, Sterile,… Presence of Particulate Matter: Potential vendor glass issue - glass spiticules (glass strands) were identified during… Hospira Inc. Terminated
Class II November 27, 2013 ONDANSETRON Ondansetron Injection, USP, 4 mg/2 mL (2 mg/mL), 2 mL Single-dose Vial, Rx Only, Sterile,… Presence of Particular Matter: Potential vendor glass issue - glass spiticules (glass strands) were identified during… Hospira Inc. Terminated
Class II November 27, 2013 Copaxone Copaxone (glatiramer acetate injection), 20 mg/1 mL, 1 mL pre-filled syringe, packaged in… Presence of Particulate Matter: A foreign particle found in a pre-filled syringe was reported through a consumer… Teva Pharmaceuticals USA Terminated
Class II November 13, 2013 Ropinirole, extended-release tablets, 2 mg, 90 count bottle, Rx only, Manufactured in… Cross contamination with other products: Sandoz is recalling certain lots of Ropinirole Extended Release Tablets 2 mg… Sandoz, Inc Terminated
Class II November 13, 2013 Amlodipine Besylate Tablets, USP 10 mg, packaged in a) 90-count bottles (NDC… CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to… Mylan Pharmaceuticals Inc. Terminated
Class II November 13, 2013 Amlodipine Besylate and Benazepril HCl Capsules, 10 mg/40 mg, 100-count bottles, Rx only,… CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to… Mylan Pharmaceuticals Inc. Terminated
Class II November 13, 2013 Ciprofloxacin Tablets, USP, 500 mg,100-count bottles, Rx only, Mylan Pharmaceuticals… CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to… Mylan Pharmaceuticals Inc. Terminated
Class II November 13, 2013 Amlodipine Besylate and Benazepril HCl Capsules, 5 mg/10 mg, packaged in a) 100-count… CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to… Mylan Pharmaceuticals Inc. Terminated
Class II November 13, 2013 Amlodipine Besylate and Benazepril HCl Capsules, 5 mg/20 mg, packaged in a) 100-count… CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to… Mylan Pharmaceuticals Inc. Terminated
Class II November 13, 2013 Amlodipine Besylate Tablets, USP, 2.5 mg, packaged in a) 90-count bottles (NDC… CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to… Mylan Pharmaceuticals Inc. Terminated
Class II November 13, 2013 Amlodipine Besylate and Benazepril HCl Capsules, 2.5 mg/10 mg, 100-count bottles, Rx… CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to… Mylan Pharmaceuticals Inc. Terminated
Class II November 13, 2013 Ciprofloxacin Tablets, USP, 250 mg, 100-count bottles, Rx only, Mylan Pharmaceuticals… CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to… Mylan Pharmaceuticals Inc. Terminated
Class II November 13, 2013 Amlodipine Besylate and Benazepril HCl Capsules, 10mg/20mg, in 100 count bottles (NDC#… CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to… Mylan Pharmaceuticals Inc. Terminated
Class II November 13, 2013 Lamotrigine Tablets, USP, 200 mg, packaged in a) 60-count bottles (NDC 0378-4254-91) and… CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to… Mylan Pharmaceuticals Inc. Terminated
Class II November 13, 2013 Amlodipine Besylate and Benazepril HCl Capsules, 5 mg/40 mg, 100-count bottles, Rx only,… CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to… Mylan Pharmaceuticals Inc. Terminated
Class II November 13, 2013 Amlodipine Besylate Tablets, USP, 5 mg, packaged in a) 90-count bottles (NDC… CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to… Mylan Pharmaceuticals Inc. Terminated
Class II November 13, 2013 Irinotecan Hydrochloride Irinotecan Hydrochloride Injection, 100 mg/5 mL (20 mg/mL), 1 x 5 mL Single Dose Vial per… Superpotent Drug: a recent review of the USP revealed that an incorrect calculation was used to determine the amount of… West-Ward Pharmaceutical Corp. Terminated
Class II November 13, 2013 Irinotecan Hydrochloride Irinotecan Hydrochloride Injection, 40 mg/2 mL (20 mg/mL), 1 x 2 mL Single Dose Vial per… Superpotent Drug: a recent review of the USP revealed that an incorrect calculation was used to determine the amount of… West-Ward Pharmaceutical Corp. Terminated
Class II November 13, 2013 Extended Phenytoin Sodium Extended Phenytoin Sodium Capsules, USP, 100 mg, 1000 CAPSULES, Rx only, amneal… Failed dissolution specifications; 18 month CRT Amneal Pharmaceuticals of New York, LLC. Terminated
Class II November 13, 2013 Prolia (denosumab) Injection, 60 mg/mL, 1 x 60 mg Single Use Prefilled Syringe per… Presence of Particulate Matter: Visible cellulose fibers were observed in a small number of prefilled syringes during a… Amgen, Inc. Terminated
Class II November 13, 2013 propofol Propofol Injectable Emulsion, 1%, 200 mg/20 mL (10 mg/mL), 20 mL single patient infusion… Presence of Particulate Matter: Visible particles embedded in the glass identified during a retain sample inspection. Hospira Inc. Terminated
Class II November 6, 2013 Bevacizumab 25mg/mL, prepared as pre-filled syringes in 0.05 mL and 0.06 mL sizes, Fallon… Lack of Assurance of Sterility: Fallon Pharmacy recalled Bevacizumab 25mg/mL due to sterility assurance concerns based… Fallon Wellness Pharmacy Llc Terminated
Class III October 30, 2013 Ketoconazole Shampoo, 2%, Manufactured by TOLMAR Inc., Fort Collins, CO for Sandoz Inc.,… Subpotent Tolmar, Inc. Terminated
Class III October 30, 2013 GILTUSS ANTITUSSIVE EXPECTORANT AND NASAL DECONGESTANT, 1 fl. oz. (NDC 58552-122-01) and… Subpotent; phenylephrine HCl Hi-Tech Pharmacal Co., Inc. Terminated
Class II October 30, 2013 Albuterol Sulfate Albuterol Sulfate Inhalation Solution, 0.083% 2.5 mg/3 mL for Oral Inhalation Only, Rx… Lack of Assurance of Sterility: Nephron Pharmaceuticals Corporation conducted a routine periodic aseptic process… Nephron Pharmaceuticals Corp. Terminated
Class II October 23, 2013 Concentrated Motrin (ibuprofen) Infants' Drops Oral Suspension, Original Berry Flavor 1/2… Presence of Foreign Substance: process-related particulates which may be associated with the raw materials were observed Mcneil Consumer Healthcare, Div Of Mcneil-ppc, Inc. Terminated
Class III October 16, 2013 Hydroxychloroquine Sulfate Tablets, USP, 200 mg, Rx Only, 100 Tablets per bottle, Sandoz… Failed Tablet/Capsule Specifications: Sandoz is recalling one lot of Hydroxychloroquine Sulfate Tablets, USP, 200mg,… Sandoz Incorporated Terminated
Class II October 16, 2013 Next Choice" One Dose Emergency Contraceptive (Levonorgestrel Tablet), 1.5 mg, 1… Failed Tablet/Capsule Specifications: Multiple complaints for push through tablet breakage. Watson Laboratories Inc Terminated
Class II October 16, 2013 Bupivacaine Hydrochloride 0.5% Bupivacaine HCl and Epinephrine 1:200,000 Inj., 10 mL, Single-Dose Vial, NDC… Lack of Assurance of Sterility; potential for vial breakage Hospira Inc. Terminated
Class II October 9, 2013 Ifosfamide Injection 1g/20mL, Single dose vial, Rx only, Sterile, For Intravenous Use,… Temperature abuse: Certain vials of Ifosfamide IV products were not refrigerated at certain Amerisource Bergen Drug… AmeriSource Bergen Terminated
Class II October 9, 2013 Estradiol 1.25 mg, Progesterone 25 mg/mL injectable, 20 mL sterile vials, The Apothecary… Lack of Assurance of Sterility: concerns of sterility assurance with the pharmacy's independent testing laboratory. Apothecary Shoppe Terminated
Class II October 9, 2013 Oxycodone and Acetaminophen Tablets, USP 10 mg/650 mg, CII, 100 Count Bottles, Rx Only,… Presence of Foreign Tablets/Capsules: 20 tablets of Oxycodone/APAP 7.5/500 mg were found in a sealed 100 count bottle… Watson Laboratories Inc Terminated
Class II October 9, 2013 SIH-Testosterone Cypionate 200 mg/mL Injectable, 10 mL sterile vial, The Apothecary… Lack of Assurance of Sterility: concerns of sterility assurance with the pharmacy's independent testing laboratory Apothecary Shoppe Terminated
Class II October 9, 2013 Ifosfamide Injection 3g/60 mL, Single dose vial, Rx only, Sterile, For Intravenous Use,… Temperature abuse: Certain vials of Ifosfamide IV products were not refrigerated at certain Amerisource Bergen Drug… AmeriSource Bergen Terminated
Class III October 9, 2013 Venlafaxine (Venlafaxine Hydrochloride) extended release Tablets, 225 mg, packaged in a)… Failed Dissolution Specification:12 hour time point at 18 months of product shelf life. Osmotica Pharmaceutical Corp Terminated
Class II October 9, 2013 5% Lidocaine HCl and 7.5% Dextrose Injection, USP, 2 mL Single Dose Ampuls, Rx only,… Presence of Particulate Matter; report of visible particulates in the glass ampule Hospira Inc. Terminated
Class II October 9, 2013 Acetaminophen Tablets, 500 mg, 100-count bottles, Distributed by: Marlex Pharmaceuticals,… CGMP Deviations: The recalled acetaminophen tablet lot was not manufactured under current good manufacturing practices… Marlex Pharmaceuticals, Inc. Terminated
Class II October 9, 2013 Sodium Phosphate Injectable, 150mM/50mL Phosphorus 200mEq/50mL Sodium, 50 mL Single Dose… Lack of Assurance of Sterility:The product lots are being recalled due to laboratory results (from a contract lab)… Triangle Compounding Terminated
Class II October 9, 2013 Histamine, 10 ng/mL Injectable, MDV, Rx only, Triangle Compounding Pharmacy, 3700 Regency… Lack of Assurance of Sterility:The product lots are being recalled due to laboratory results (from a contract lab)… Triangle Compounding Terminated
Class II October 2, 2013 Walgreens Progesterone in Ethyl Oleate 50 mg per mL Injection, 10 mL vial, Inject 1 mL… Lack of Assurance of Sterility: Walgreens Specialty Pharmacy is recalling one lot of Progesterone in Ethyl Oleate… Walgreens Co Terminated
Class II October 2, 2013 Pyridostigmine Bromide Tablets 60 mg, USP Rx Only 100 Tablets, Manufactured and… Failed Stability Specifications: Pyridostigmine Bromide tablets, is being recalled due to an out of specification test… Core Pharma Llc Terminated
Class II September 25, 2013 Epinephrine 1:1,000 (1mg/mL) Sterile Solution for injection, Preservative Free/Sulfite… Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results (from a contract lab)… JCB Labs LLC Terminated
Class II September 25, 2013 Lidocaine/Phenylephrine PF 1%/1.5% Injectible vials, 1 mL Single Use Vial, Compounded by… Lack of Assurance of Sterility: Leiter Pharmacy is recalling due bacterial contamination found after investigation at… Leiter's Pharmacy Terminated
Class II September 25, 2013 L-Glutathione 200 mg/mL PF, 100 mL, Medaus Pharmacy 1-800-526-9183 Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results (from a contract lab)… Medaus, Inc. Terminated
Class II September 25, 2013 Lipo-Injection w/ Lidocaine (PF), Ascorbic Acid 50 mg; B1-50 mg; B2-5-PO4-5 mg; B3-50 mg;… Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results (from a contract lab)… Medaus, Inc. Terminated
Class III September 25, 2013 Hydrocodone Bitartrate and Acetaminophen Tablets, 7.5 mg/650 mg Tablets, 500 Count… Defective Container: Defective bottles may not have tamper evident seals properly seated, and therefore it may be… Watson Laboratories Inc Terminated
Class II September 25, 2013 Testosterone Cyp 200 mg/mL, W/Pres. (Benzyl ETOH), 3 mL, Medaus pharmacy 1-800-526-9183 Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results (from a contract lab)… Medaus, Inc. Terminated
Class II September 25, 2013 Magnesium Chl 200 mg/mL PF, 100 mL, Medaus Pharmacy 1-800-526-9183 Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results (from a contract lab)… Medaus, Inc. Terminated
Class II September 25, 2013 Hyaluron (hyaluronidase) 150 units/mL Preserved Solution, 1 mL, Multi Dose Vial,… Lack of Assurance of Sterility: Leiter Pharmacy is recalling due bacterial contamination found after investigation at… Leiter's Pharmacy Terminated
Class II September 25, 2013 Vancomycin PF (BSS) 1%, 1 mL, Avella Specialty Pharmacy, Phoenix, AZ 85085, 877-782-7684 Lack of Assurance of Sterility: Avella Specialty Pharmacy is recalling bevacizumab and vancomycin due to concerns of… Avella of Deer Valley, Inc. Terminated
Class II September 25, 2013 Dextrose 50% Preservative Free SDV Injection Solution, 50 mL Single dose vial, IV… Lack of Assurance of Sterility: Leiter Pharmacy is recalling due bacterial contamination found after investigation at… Leiter's Pharmacy Terminated
Class II September 25, 2013 NA Ascorbate 500 mg/mL, PF, 100 mL, Medaus Pharmacy 1-800-526-9183 Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results (from a contract lab)… Medaus, Inc. Terminated
Class II September 25, 2013 Vicks NyQuil Cold and Flu Nighttime Relief, Liquid Twin Pack, (Acetaminophen 650mg,… Incorrect/ Undeclared Excipients: NyQuil Liquid Original bottles were inadvertently overwrapped with NyQuil Liquid… Procter & Gamble Co Terminated
Class II September 25, 2013 Bevacizumab 1.25 mg/0.05 mL PF, Avella Specialty Pharmacy, Phoenix, AZ, 85085,… Lack of Assurance of Sterility: Avella Specialty Pharmacy is recalling bevacizumab and vancomycin due to concerns of… Avella of Deer Valley, Inc. Terminated
Class II September 25, 2013 Hydroxocobalamin MDV 5 mg/mL (5,000 mcg/mL) Inj., 10 mL vial X 3, Eastern States… Lack of Assurance of Sterility: The pharmacy is recalling one lot of Hydroxocobalamin MDV 5mg/mL due to failed… Northern New England Compounding Pharmacy LLC Terminated
Class II September 25, 2013 Taurine 50 mg/mL PF, 100 mL, Medaus Pharmacy 1-800-526-9183 Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results (from a contract lab)… Medaus, Inc. Terminated
Class II September 25, 2013 Sodium Citrate 4% Solution for Injection, 30 mL Multi Dose Vial, Sterile Solution for… Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results (from a contract lab)… JCB Labs LLC Terminated
Class II September 25, 2013 Pyridoxine HCL 100 mg/mL NS (PF), 30 mL, Medaus Pharmacy 1-800-526-9183 Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results (from a contract lab)… Medaus, Inc. Terminated
Class II September 25, 2013 Sodium Thiosulfate 25%, 250 mg/mL (12.5 g/50mL), PF Sterile Solution for Injection, 50 mL… Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results (from a contract lab)… JCB Labs LLC Terminated
Class II September 25, 2013 Bevacizumab (Avastin) 2.5mg/0.1mL PF Inj., 0.1 mL syringe, Compounded by Leiter's… Lack of Assurance of Sterility: Leiter Pharmacy is recalling due bacterial contamination found after investigation at… Leiter's Pharmacy Terminated
Class II September 25, 2013 Acetylcysteine 20% Solution, Preservative Free, 4 mL Sterile Single Dose Vial, Not for… Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results (from a contract lab)… JCB Labs LLC Terminated
Class II September 25, 2013 Sodium Citrate 4% containing Gentamicin 320 mcg/mL, Solution for Injection, 30 mL Multi… Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results (from a contract lab)… JCB Labs LLC Terminated
Class II September 25, 2013 NA Ascorbate 500 mg/mL, non corn PF, 100ML, Medaus Pharmacy, 1-800-526-9183 Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results (from a contract lab)… Medaus, Inc. Terminated
Class II September 25, 2013 Ibuprofen IBU (TM) IBUPROFEN Tablets, USP, 800 mg, 500 -count bottle,(NDC 55111-684-05) Rx only,… Labeling: Incorrect or missing lot and/or exp date- This product is being recalled due to an incorrect expiration date… Dr. Reddy's Laboratories, Inc. Terminated
Class III September 25, 2013 Spiriva SPIRIVA HandiHaler (Tiotropium Bromide Inhalation Powder) Capsules 18 mcg per dose, Rx… Presence of Foreign Substance: This recall is being conducted due to the potential for extrinsic foreign particles in… Boehringer Ingelheim Roxane Inc Terminated
Class II September 18, 2013 PARABEN WATER FOR INJECTION, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE,… Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control… Beacon Hill Medical Pharmacy, P.C. Terminated
Class II September 18, 2013 CALCIUM EDTA 200 MG/ML INJECTABLE, all configurations, FOR INTRAVENO AND SQ USE ONLY,… Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control… Beacon Hill Medical Pharmacy, P.C. Terminated
Class II September 18, 2013 CALCIUM CHLORIDE 100 MG/ML INJECTABLE, all presentations, FOR INTRAVENO AND SQ USE ONLY,… Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control… Beacon Hill Medical Pharmacy, P.C. Terminated
Class II September 18, 2013 PROCAINE P/F 20 MG/ML INJECTABLE, all presentations, FOR INTRAVENO AND SQ USE ONLY,… Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control… Beacon Hill Medical Pharmacy, P.C. Terminated
Class II September 18, 2013 PUMICE/LIDOCAINE HCL 1.5%/1% INJ SUSP, all presentations, FOR INTRAVENO AND SQ USE ONLY,… Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control… Beacon Hill Medical Pharmacy, P.C. Terminated
Class II September 18, 2013 ESTRIOL 5 MG/ML OIL INJ SOLN, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE,… Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control… Beacon Hill Medical Pharmacy, P.C. Terminated
Class II September 18, 2013 MIC-CARN + B6/B12/LIDOCAINE 25/50/50/175MCG/1/0.1MG/ML INJECTABLE, all presentations, FOR… Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control… Beacon Hill Medical Pharmacy, P.C. Terminated
Class II September 18, 2013 ARGININE (R-GENE) 100 MG/ML INJECTABLE, all presentations, FOR INTRAVENO AND SQ USE ONLY,… Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control… Beacon Hill Medical Pharmacy, P.C. Terminated
Class II September 18, 2013 SODIUM BICARBONATE PF 8.4% INJECTABLE, all presentations, FOR INTRAVENO AND SQ USE ONLY,… Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control… Beacon Hill Medical Pharmacy, P.C. Terminated
Class II September 18, 2013 Glutathione 100 mg/mL Injectable, 100mL Vial, Use as Directed, RX, Creative Compounds,… Glutathione 100 mg/mL injectable human drug is recalled due to Out Of Specification results or potential bacterial… Creative Compounds Terminated
Class II September 18, 2013 GLUTATHIONE/LIDO 100MG/2%/ML (PF) INJ SOLN, all presentations, FOR INTRAVENO and SQ USE… Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control… Beacon Hill Medical Pharmacy, P.C. Terminated
Class II September 18, 2013 B-12/LIDOCAINE 25/10MG/ML, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX… Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control… Beacon Hill Medical Pharmacy, P.C. Terminated
Class II September 18, 2013 DEXTROSE PF 50% INJECTABLE, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX… Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control… Beacon Hill Medical Pharmacy, P.C. Terminated
Class II September 18, 2013 Testosterone Cypionate (Sesame Oil) 200mg/mL for injection in 10mL amber vials, Park… Lack of Assurance of Sterility: Park Compounding is voluntarily recalling two lots of Methylcobalamin 5mg/ml and… South Coast Specialty Compounding, Inc. Terminated
Class II September 18, 2013 SELENIUM 400 MCG/ML INJECTABLE, all presentations, FOR INTRAVENO AND SQ USE ONLY,… Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control… Beacon Hill Medical Pharmacy, P.C. Terminated
Class II September 18, 2013 VITAMIN B-COMPLEX INJECTABLE, VITAMIN B-COMPLEX SL SOLN and VITAMIN B-COMPLEX (PF)… Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control… Beacon Hill Medical Pharmacy, P.C. Terminated
Class II September 18, 2013 HYALURONIDASE 150 U/ML and 200 U/ML INJECTABLE, all presentations, FOR INTRAVENO and SQ… Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control… Beacon Hill Medical Pharmacy, P.C. Terminated
Class II September 18, 2013 MIC-CARN MAX 15/100/50/1 MG/ML INJECTABLE, all presentations, FOR INTRAVENO and SQ USE… Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control… Beacon Hill Medical Pharmacy, P.C. Terminated
Class II September 18, 2013 EDETATE DISODIUM 150 MG/ML INJECTABLE, all presentations, FOR INTRAVENO AND SQ USE ONLY,… Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control… Beacon Hill Medical Pharmacy, P.C. Terminated
Class II September 18, 2013 Zinc Sulfate 1 mg/ml INJECTABLE, all configurations, FOR INTRAVENO AND SQ USE ONLY,… Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control… Beacon Hill Medical Pharmacy, P.C. Terminated
Class II September 18, 2013 Multitrace-5 Concentrate (Trace Elements -5 Conc Injection) Solution, Sterile 10mL… Lack of Assurance of Sterility: Park Compounding is recalling Methylcobalamin 5 mg/mL, Multitrace-5 Concentrate, and… South Coast Specialty Compounding, Inc. Terminated
Class II September 18, 2013 LIDOCAINE MDV 1% INJECTABLE, LIDOCAINE MDV 20 MG/ML INJECTABLE and Lidocaine PF 20 MG/ML… Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control… Beacon Hill Medical Pharmacy, P.C. Terminated
Class II September 18, 2013 Methylcobalamin Injection 5 mg/mL, For IM or SC Administration, Sterile 30 mL Multiple… Lack of Assurance of Sterility: Park Compounding is recalling Methylcobalamin 5 mg/mL, Multitrace-5 Concentrate, and… South Coast Specialty Compounding, Inc. Terminated
Class II September 18, 2013 BUPRENORPHINE 0.1/0.05 MG/ML CREAM, all configurations, FOR INTRAVENO AND SQ USE ONLY,… Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control… Beacon Hill Medical Pharmacy, P.C. Terminated
Class II September 18, 2013 FREAMINE III ALT. 8.5% INJECTABLE, all presentations, FOR INTRAVENO AND SQ USE ONLY,… Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control… Beacon Hill Medical Pharmacy, P.C. Terminated
Class II September 18, 2013 KETOROLAC TROMETHAMINE 60 MG/ML INJECTABLE, all presentations, FOR INTRAVENO and SQ USE… Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control… Beacon Hill Medical Pharmacy, P.C. Terminated
Class II September 18, 2013 ACETYLCYSTEINE 100 MG/ML INJ SOLN, all presentations, FOR INTRAVENO AND SQ USE ONLY,… Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control… Beacon Hill Medical Pharmacy, P.C. Terminated
Class II September 18, 2013 B-COMPLEX/LIDOCAINE 2% INJECTION, all presentations, FOR INTRAVENO AND SQ USE ONLY,… Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control… Beacon Hill Medical Pharmacy, P.C. Terminated
Class II September 18, 2013 VITAMIN D 50,000 I.U./ML INJECTABLE, all configurations, FOR INTRAVENO AND SQ USE ONLY,… Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control… Beacon Hill Medical Pharmacy, P.C. Terminated
Class II September 18, 2013 BI-MIX PHENTOLAMINE/PAPAVERINE 0.5 MG/30 MG/ML and BI-MIX PHENTOLAMINE/PAPAVERINE 1 MG/30… Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control… Beacon Hill Medical Pharmacy, P.C. Terminated
Class II September 18, 2013 NA. Phenylbutyrate 200 mg/mL, SDV, a) 10 mL, b) 25 mL, and c) 50 mL, WELLNESS PHARMACY,… Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results indicating microbial… Wellness Pharmacy, Inc. Terminated
Class II September 18, 2013 MAGNESIUM SULFATE 50% INJECTABLE, all presentations, FOR INTRAVENO and SQ USE ONLY,… Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control… Beacon Hill Medical Pharmacy, P.C. Terminated
Class II September 18, 2013 GLYCINE 50 MG/ML INJECTABLE, all presentations, FOR INTRAVENO and SQ USE ONLY, STERILE,… Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control… Beacon Hill Medical Pharmacy, P.C. Terminated
Class II September 18, 2013 PYRIDOXINE HCL P/F 100 MG/ML INJECTABLE, all presentations, FOR INTRAVENO AND SQ USE… Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control… Beacon Hill Medical Pharmacy, P.C. Terminated
Class II September 18, 2013 EDTA disodium 150 mg/mL Sterile Injection, 20 mL Multi Dose Vial, Pharmacy Creations,… Lack of Assurance of Sterility: Pharmacy Creations is recalling Lidocaine 1% PF Sterile Injection and EDTA disodium 150… Pharmacy Creations Terminated
Class II September 18, 2013 MAGNESIUM CHLORIDE HEXAHYDRATE 20% INJECTABLE, all presentations, FOR INTRAVENO and SQ… Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control… Beacon Hill Medical Pharmacy, P.C. Terminated
Class II September 18, 2013 GLYCYRRHIZIC ACID 8 MG/ML INJECTABLE, all presentations, FOR INTRAVENO and SQ USE ONLY,… Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control… Beacon Hill Medical Pharmacy, P.C. Terminated
Class II September 18, 2013 COPPER 0.4MG/ML INJECTABLE, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX… Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control… Beacon Hill Medical Pharmacy, P.C. Terminated
Class II September 18, 2013 Magnesium Sulfate Hepta 50% PF, Single Use Vial, a) 2 mL, b) 10 mL, WELLNESS PHARMACY,… Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results indicating microbial… Wellness Pharmacy, Inc. Terminated
Class II September 18, 2013 HYDROXYPROGESTERONE CAPROATE 250 MG/ML OIL INJ SOLN, all presentations, FOR INTRAVENO and… Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control… Beacon Hill Medical Pharmacy, P.C. Terminated
Class II September 18, 2013 SODIUM HYDROXIDE 10% (W/V)/WATER FOR INJECTION, all presentations, FOR INTRAVENO AND SQ… Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control… Beacon Hill Medical Pharmacy, P.C. Terminated
Class II September 18, 2013 GLUTAMINE 100 MG/ML INJ SOLN, all presentations, FOR INTRAVENO and SQ USE ONLY, STERILE,… Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control… Beacon Hill Medical Pharmacy, P.C. Terminated
Class II September 18, 2013 NALTREXONE 1 MG/ML INJECTABLE and 200 MG/ML INJECTABLE, all presentations, FOR INTRAVENO… Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control… Beacon Hill Medical Pharmacy, P.C. Terminated
Class II September 18, 2013 SERMORELIN ACETATE 10 MG INJECTABLE, all presentations, FOR INTRAVENO AND SQ USE ONLY,… Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control… Beacon Hill Medical Pharmacy, P.C. Terminated
Class II September 18, 2013 Lidocaine 1% PF Sterile Injection, 30 mL Single Dose Vial, Pharmacy Creations, Randolph,… Lack of Assurance of Sterility: Pharmacy Creations is recalling Lidocaine 1% PF Sterile Injection and EDTA disodium 150… Pharmacy Creations Terminated
Class II September 18, 2013 Testosterone CYP (Sesame Oil) 200mg/mL Injection, 10 mL Vial, University Compounding… Lack of Assurance of Sterility: University Compounding Pharmacy is voluntarily recalling certain pharmacy products due… University Compounding Pharmacy Terminated
Class II September 18, 2013 B-12 REJUV 25 MG/ML INJECTABLE, all configurations, FOR INTRAVENO AND SQ USE ONLY,… Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control… Beacon Hill Medical Pharmacy, P.C. Terminated
Class II September 18, 2013 ESTRADIOL CYP/PROG/TEST CYP 0.5/10/10 MG/ML OIL INJ SOLN, all presentations, FOR… Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control… Beacon Hill Medical Pharmacy, P.C. Terminated
Class II September 18, 2013 HYDROXOCOBALAMIN (VITAMIN B12A) 1 MG/ML INJECTABLE, all presentations, FOR INTRAVENO and… Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control… Beacon Hill Medical Pharmacy, P.C. Terminated
Class II September 18, 2013 Testosterone Cypionate/Testosterone Propionate 180-20 mg/mL Injection, 10 mL Vial,… Lack of Assurance of Sterility: University Compounding Pharmacy is voluntarily recalling certain pharmacy products due… University Compounding Pharmacy Terminated
Class II September 18, 2013 PROG/TEST CYP 15/7.5 MG/ML OIL INJ SOLN, all presentations, FOR INTRAVENO AND SQ USE… Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control… Beacon Hill Medical Pharmacy, P.C. Terminated
Class II September 18, 2013 LIPO-PLEX INJECTABLE, all presentations, FOR INTRAVENO and SQ USE ONLY, STERILE, RX ONLY,… Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control… Beacon Hill Medical Pharmacy, P.C. Terminated
Class II September 18, 2013 Testosterone Cypionate (Sesame Oil) 200mg/mL Injection, 10 mL Vial, University… Lack of Assurance of Sterility: University Compounding Pharmacy is voluntarily recalling certain pharmacy products due… University Compounding Pharmacy Terminated
Class II September 18, 2013 BI-TROPIN S-2 INJECTABLE, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX… Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control… Beacon Hill Medical Pharmacy, P.C. Terminated
Class II September 18, 2013 B-COMPLEX/LIDO/B-12, 25MG/ML INJECTABLE, all presentations, FOR INTRAVENO AND SQ USE… Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control… Beacon Hill Medical Pharmacy, P.C. Terminated
Class II September 18, 2013 CYANOCOBALAMIN 1000 MCG/ML INJ SOLN, all presentations, FOR INTRAVENO AND SQ USE ONLY,… Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control… Beacon Hill Medical Pharmacy, P.C. Terminated
Class II September 18, 2013 L-TRYPTOPHAN 300 MG/ML INJECTABLE, all presentations, FOR INTRAVENO and SQ USE ONLY,… Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control… Beacon Hill Medical Pharmacy, P.C. Terminated
Class II September 18, 2013 MANGANESE SULFATE 0.1 MG/ML INJECTABLE, all configurations, FOR INTRAVENO AND SQ USE… Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control… Beacon Hill Medical Pharmacy, P.C. Terminated
Class II September 18, 2013 GLUTATHIONE/METHYL/LIDO 100/25/20 MG/ML INJ SOLN and GLUTATHIONE/METHYL/LIDO… Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control… Beacon Hill Medical Pharmacy, P.C. Terminated
Class II September 18, 2013 ASCORBIC ACID (CORN SOURCE) 500 MG/ML INJECTABLE, all configurations, FOR INTRAVENO AND… Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control… Beacon Hill Medical Pharmacy, P.C. Terminated
Class II September 18, 2013 SODIUM PHOSPHATE MONOBASIC/WATER FOR INJECTION 10%, all presentations, FOR INTRAVENO AND… Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control… Beacon Hill Medical Pharmacy, P.C. Terminated
Class II September 18, 2013 TRIAMCINOLONE ACETONIDE 80 MG/ML INJ SUSP, all configurations, FOR INTRAVENO AND SQ USE… Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control… Beacon Hill Medical Pharmacy, P.C. Terminated
Class II September 18, 2013 QUAD AMINO BLEND 150/75/150/75 MG/ML INJECTABLE, all presentations, FOR INTRAVENO AND SQ… Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control… Beacon Hill Medical Pharmacy, P.C. Terminated
Class II September 18, 2013 MULTITRACE-5 INJECTABLE, all presentations, FOR INTRAVENO and SQ USE ONLY, STERILE, RX… Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control… Beacon Hill Medical Pharmacy, P.C. Terminated
Class II September 18, 2013 B12/E2/E3/PROG/TEST 1/3.75/2.5/50/45 MG/ML OIL INJ SOLN, all presentations, FOR INTRAVENO… Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control… Beacon Hill Medical Pharmacy, P.C. Terminated
Class II September 18, 2013 DMSO 50% INJ 50 ML VIAL INJECTABLE, all presentations, FOR INTRAVENO AND SQ USE ONLY,… Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control… Beacon Hill Medical Pharmacy, P.C. Terminated
Class II September 18, 2013 Methyl B12 1 mg/mL P.F., Single-Use Vial, a) 1 mL, b) 10 mL, WELLNESS PHARMACY,… Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results indicating microbial… Wellness Pharmacy, Inc. Terminated
Class II September 18, 2013 TESTOSTERONE PROPIONATE 100 MG/ML OIL INJ SOLN, all configuration, FOR INTRAVENO AND SQ… Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control… Beacon Hill Medical Pharmacy, P.C. Terminated
Class II September 18, 2013 PGE-1, 100 mcg/mL Injection in Normal Saline, 50 mL, University Compounding Pharmacy,… Lack of Assurance of Sterility: University Compounding Pharmacy is voluntarily recalling certain pharmacy products due… University Compounding Pharmacy Terminated
Class II September 18, 2013 K EFFERVESCENT TABLETS, 25 meq POTASSIUM (977 mg), ORANGE FLAVORED, Potassium Bicarbonate… LABELING: Label Mix-up: 30 count Effervescent Potassium/Chloride Tablets, may be labeled as 30 count K Effervescent… Qualitest Pharmaceuticals Terminated
Class II September 18, 2013 SODIUM PHOSPHATE DIBASIC/WATER FOR INJECTION 10%, all presentations, FOR INTRAVENO AND SQ… Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control… Beacon Hill Medical Pharmacy, P.C. Terminated
Class II September 18, 2013 ESTRADIOL CYPIONATE 5, 10, 40 MG/ML OIL INJ SOLN, all configuration, FOR INTRAVENO AND SQ… Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control… Beacon Hill Medical Pharmacy, P.C. Terminated
Class II September 18, 2013 Dexpanthenol 250 mg/mL PF, Single Use Vial, 1 mL, WELLNESS PHARMACY, 1-800-227-2627 Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results indicating microbial… Wellness Pharmacy, Inc. Terminated
Class II September 18, 2013 OXYTOCIN 10 UNITS/ML, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY,… Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control… Beacon Hill Medical Pharmacy, P.C. Terminated
Class II September 18, 2013 METHYLPREDNISOLONE ACETATE 40 MG/ML and 80 MG/ML INJECTABLE, all presentations, FOR… Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control… Beacon Hill Medical Pharmacy, P.C. Terminated
Class II September 18, 2013 DMPS 50mg/ml INJECTABLE, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX… Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control… Beacon Hill Medical Pharmacy, P.C. Terminated
Class II September 18, 2013 Dexpanthenol 250mg/ml PF, Qty: 1mL, WELLNESS PHARMACY, 1-800-227-2627 The product lots are being recalled due to laboratory results indicating microbial contamination. The FDA was concerned… Wellness Pharmacy, Inc. Terminated
Class II September 18, 2013 ALPROSTADIL 100 MCG/ML INJ SOLN, all sizes, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX… Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control… Beacon Hill Medical Pharmacy, P.C. Terminated
Class II September 18, 2013 TESTOSTERONE HYPOALLERGENIC 200 MG/ML INJECTABLE and TESTOSTERONE AQUEOUS 100 MG/ML… Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control… Beacon Hill Medical Pharmacy, P.C. Terminated
Class II September 18, 2013 DEXPANTHENOL 250 MG/ML INJECTABLE, all presentations, FOR INTRAVENO AND SQ USE ONLY,… Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control… Beacon Hill Medical Pharmacy, P.C. Terminated
Class II September 18, 2013 GLUTATHIONE 200 MG/ML (PF) INJ SOLN, all presentations, FOR INTRAVENO and SQ USE ONLY,… Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control… Beacon Hill Medical Pharmacy, P.C. Terminated
Class II September 18, 2013 CALCIUM EDTA 300 MG/ML INJECTABLE, all configurations, FOR INTRAVENO AND SQ USE ONLY,… Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control… Beacon Hill Medical Pharmacy, P.C. Terminated
Class II September 18, 2013 DEXAMETHASONE SODIUM PHOSPHATE 10 MG/ML INJECTABLE, all presentations, FOR INTRAVENO AND… Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control… Beacon Hill Medical Pharmacy, P.C. Terminated
Class II September 18, 2013 NALBUPHINE HCL 20 MG/ML INJECTABLE, all presentations, FOR INTRAVENO and SQ USE ONLY,… Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control… Beacon Hill Medical Pharmacy, P.C. Terminated
Class II September 18, 2013 PHOSPHATIDYLCHOLINE 50 MG/ML INJECTABLE, all presentations, FOR INTRAVENO AND SQ USE… Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control… Beacon Hill Medical Pharmacy, P.C. Terminated
Class II September 18, 2013 ESTRADIOL VALERATE W/ LIDOCAINE 1% 40 MG/ML OIL INJ SOLN, all configurations, FOR… Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control… Beacon Hill Medical Pharmacy, P.C. Terminated
Class II September 18, 2013 TRI-MIX 10 MCG/30 MG/1 MG/ML INJ SOLN and TRI-MIX 30 MCG/15 MG/2 MG/ML INJ SOLN, all… Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control… Beacon Hill Medical Pharmacy, P.C. Terminated
Class II September 18, 2013 RL Glutathione 100 mg/mL, SDV PF,a) 1 mL, b) 2 mL, c) 3 mL, and d) 4 mL, WELLNESS… Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results indicating microbial… Wellness Pharmacy, Inc. Terminated
Class II September 18, 2013 PGE-1, 20 mcg/mL Injection in Normal Saline, 10 mL, University Compounding Pharmacy,… Lack of Assurance of Sterility: University Compounding Pharmacy is voluntarily recalling certain pharmacy products due… University Compounding Pharmacy Terminated
Class II September 18, 2013 POTASSIUM CHLORIDE 2 MEQ/ML INJECTABLE, all presentations, FOR INTRAVENO AND SQ USE ONLY,… Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control… Beacon Hill Medical Pharmacy, P.C. Terminated
Class II September 18, 2013 H.C.G. (COMPOUNDED), 5,000, 8, 000, 10,000, 11,000 and 12,000 UNIT VIALS INJECTABLE, all… Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control… Beacon Hill Medical Pharmacy, P.C. Terminated
Class II September 18, 2013 LIPOIC ACID 100 MG/ML and 200 MG/ML INJECTABLE, all presentations, FOR INTRAVENO and SQ… Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control… Beacon Hill Medical Pharmacy, P.C. Terminated
Class II September 18, 2013 NANDROLONE DECANOATE 100 MG/ML and 200 MG/ML OIL INJ SOLN, all presentations, FOR… Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control… Beacon Hill Medical Pharmacy, P.C. Terminated
Class II September 18, 2013 ASCORBIC ACID ( non-CORN SOURCE) 500 MG/ML INJECTABLE, all presentations, FOR INTRAVENO… Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control… Beacon Hill Medical Pharmacy, P.C. Terminated
Class II September 18, 2013 EFFERVESCENT POTASSIUM/CHLORIDE TABLETS, 25 meq Potassium Chloride (1865 mg), POTASSIUM… LABELING: Label Mix-up: 30 count Effervescent Potassium/Chloride Tablets, may be labeled as 30 count K Effervescent… Qualitest Pharmaceuticals Terminated
Class II September 18, 2013 ALPROSTADIL, 50 MCG/ML INJ SOLN, all presentations, FOR INTRAVENO AND SQ USE ONLY,… Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control… Beacon Hill Medical Pharmacy, P.C. Terminated
Class II September 18, 2013 FUROSEMIDE 10 MG/ML INJECTABLE, all presentations, FOR INTRAVENO AND SQ USE ONLY,… Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control… Beacon Hill Medical Pharmacy, P.C. Terminated
Class II September 18, 2013 TESTOSTERONE CYPIONATE 100 MG/ML, 200 MG/ML, 20 MG/ML OIL INJ SOLN, all configuration,… Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control… Beacon Hill Medical Pharmacy, P.C. Terminated
Class II September 18, 2013 CHROMIUM 4 MCG/ML INJECTABLE, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE,… Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control… Beacon Hill Medical Pharmacy, P.C. Terminated
Class II September 18, 2013 PROGESTERONE 50 MG/ML OIL INJ SOLN, all presentations, FOR INTRAVENO AND SQ USE ONLY,… Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control… Beacon Hill Medical Pharmacy, P.C. Terminated
Class II September 18, 2013 TRIPTROPIN PLUS INJECTABLE, all configurations, FOR INTRAVENO AND SQ USE ONLY, STERILE,… Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control… Beacon Hill Medical Pharmacy, P.C. Terminated
Class II September 18, 2013 HYDROGEN PEROXIDE 3% INJECTABLE, all presentations, FOR INTRAVENO and SQ USE ONLY,… Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control… Beacon Hill Medical Pharmacy, P.C. Terminated
Class II September 18, 2013 TRIPLE-TESTOSTERONE 250 MG/ML OIL INJ SOLN and TRIPLE-TESTOSTERONE 200 MG/ML OIL INJ… Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control… Beacon Hill Medical Pharmacy, P.C. Terminated
Class II September 18, 2013 METHYLCOBALAMIN 1 mg/ml, 5 mg/ml, 10 mg/ml, 25 mg/ml and METHYLCOBALAMIN (PF) 1 MG/ML, 25… Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control… Beacon Hill Medical Pharmacy, P.C. Terminated
Class II September 18, 2013 DUAL-TESTOSTERONE 20, 50, 100, 150, 200 MG/ML OIL INJ SOLN, all presentations, FOR… Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control… Beacon Hill Medical Pharmacy, P.C. Terminated
Class II September 18, 2013 propofol Propofol Injectable Emulsion, 1%, 200 mg/20 mL (10 mg/mL), packaged in 5 Units x 20 mL… Presence of Particulate Matter: Visible particulate embedded in the glass vial was observed and confirmed in a sample… Hospira Inc. Terminated
Class I September 11, 2013 SexVoltz All Natural Herbal Supplement, packaged in 1 & 2 capsule blister packs and 4, 10… Marketed Without an Approved NDA/ANDA; products have been found to contain tadalafil, the active ingredient in an FDA… Beamonstar Products Terminated
Class I September 11, 2013 Velextra All-Natural Herbal Supplement, packaged in 1 & 2 capsule blister packs and 4, 10… Marketed Without an Approved NDA/ANDA; products have been found to contain tadalafil, the active ingredient in an FDA… Beamonstar Products Terminated
Class II September 11, 2013 CARBOplatin Injection, 600 mg/60ml, MultiDose, Rx only, Teva Parenteral Medicines, Inc.,… Lack of Assurance of Sterility: The required reduction of endotoxin was not met during the annual revalidation of the… Teva Pharmaceuticals USA, Inc. Terminated
Class II September 4, 2013 Benztropine Mesylate Injection, USP, 2 mg/mL(1 mg/1 mL), 2 mL Single Dose Vial, Rx only,… Presence of particulate matter: characterized as thin colorless flakes that are visually and chemically consistent with… Nexus Pharmaceuticals Inc Terminated
Class II September 4, 2013 Propranolol Hydrochloride Tablets, USP, 10 mg, Rx Only, 1000 count bottles, Manufactured… Failed Tablet/Capsule Specification: Teva is recalling certain lots of Propanolol HCl Tablets, 10 mg due to the… Teva Pharmaceuticals USA, Inc. Terminated
Class II September 4, 2013 Avastin, (0.05 ml, 1.25 mg/0.05ml), single unit dose syringes, Clinical Specialties… Lack of Assurance of Sterility; product linked to adverse event reports of endophthalimitis eye infections and FDA… Clinical Specialties Compounding Pharmacy Terminated
Class I September 4, 2013 Magnesium Sulfate Injection, USP, 50% (25 grams/50 mL), For IM or IV Use, 50 mL, Single… Presence of Particulate Matter: Glass particulate matter was observed in a retention sample during an annual review. Fresenius Kabi USA, LLC Terminated
Class III September 4, 2013 buPROPion Hydrochloride Extended-Release Tablets (XL), 300 mg, 30-count tablets per… Failed Dissolution Specifications: This recall is an extension of the recall initiated on 07/31/2013 for Bupropion HCl… Actavis South Atlantic LLC Terminated
Class I September 4, 2013 ENTERIC COATED ASPIRIN (NSAID), 81 mg, 120-count tablets per bottle, distributed by:… Labeling: Label Mix-Up: A complaint from a pharmacist was received that the entire contents of 1 bottle labeled as… Advance Pharmaceutical Inc Terminated
Class I September 4, 2013 Bethel 30 capsules, packaged in 30 count bottles, Distributed by BETHEL INC. New York,… Marketed Without An Approved NDA/ANDA: FDA analysis found this product contained undeclared sibutramine and… Bethel Nutritional Consulting, Inc Terminated
Class I September 4, 2013 0.9% Sodium Chloride Injection, USP, 100 mL flexible container, Rx only, Hospira, Inc.… Presence of Particulate Matter; product may contain fibrous material Hospira Inc. Terminated
Class II September 4, 2013 DIAZEPAM Diazepam Injection, USP, 5 mg/mL, 10 mL, Multiple-dose Sterile Non-pyrogenic, Fliptop… Lack of assurance of sterility: ineffective crimp on fliptop vials that may result in leaking at the neck of the vials. Hospira Inc. Terminated
Class II September 4, 2013 KETOROLAC TROMETHAMINE Ketorolac Tromethamine Inj., USP, 30 mg vial, Rx only, Hospira, Inc., Lake Forest, IL… Lack of Assurance of Sterility: Either a loose crimp or no crimp was applied to the fliptop vials. Hospira, Inc. Terminated
Class II September 4, 2013 Lidocaine Lidocaine Hydrochloride 2% and Epinephrine 1:100,000 Injection, Rx Only, For Dental Block… Subpotent Drug; Two lots of Lidocaine 2% with Epinephrine 1:100,000 Injectable, distributed under the names: Octocaine… Novocol Pharmaceutical of Canada Terminated
Class III August 28, 2013 Duet DHA Balanced, 1) 30 count tablet blister cards and 5 count softgels blister cards… Subpotent; Beta carotene (Vitamin A) Stayma Consulting Service, LLC. Terminated
Class III August 28, 2013 Duet DHA 400 ec, containing one 30-count bottle of multi-vitamin tablets (imprinted 800)… Subpotent; Beta carotene (Vitamin A) Stayma Consulting Service, LLC. Terminated
Class III August 28, 2013 Nata Komplete, containing one 30-count bottle of multi-vitamin tablets (imprinted 909),… Subpotent; Beta carotene (Vitamin A) Stayma Consulting Service, LLC. Terminated
Class II August 28, 2013 IRINOTECAN HYDROCHLORIDE INJECTION, 40 mg/2 mL (20 mg/mL), 2 mL Single Dose Vial, Rx… Crystallization: Active pharmaceutical ingredient is precipitating in product solution. Fresenius Kabi USA LLC (FK USA) Terminated
Class III August 28, 2013 Duet DHA 430 ec, containing one 30-count bottle of multi-vitamin tablets (imprinted 800)… Subpotent; Beta carotene (Vitamin A) Stayma Consulting Service, LLC. Terminated
Class III August 28, 2013 Duet DHA 430, containing one 30-count bottle of multi-vitamin tablets (imprinted 800) and… Subpotent; Beta carotene (Vitamin A) Stayma Consulting Service, LLC. Terminated
Class III August 28, 2013 Duet DHA 400, containing one 30-count bottle of multi-vitamin tablets (imprinted 800) and… Subpotent; Beta carotene (Vitamin A) Stayma Consulting Service, LLC. Terminated
Class III August 28, 2013 Maalox Advanced Maximum Strength Antacid & Antigas (calcium carbonate and simethicone)… Labeling: Incorrect Or Missing Lot and/or Exp Date: The lot number and/or expiration date may be illegible on the outer… Novartis Consumer Health Terminated
Class II August 28, 2013 Eyebright Concentrate Topical Eye Rinse, 1, 2, 4, 8, 16 & 32 fl oz bottles, Produced and… Lack of Assurance of Sterility; Lack of Assurance of Sterility; product not manufactured under sterile conditions as… Earthlabs, Inc. DBA Wise Woman Herbals Terminated
Class III August 28, 2013 Maalox Extra Strength Antacid with Anti-Gas (calcium carbonate and simethicone) chewable… Labeling: Incorrect Or Missing Lot and/or Exp Date: The lot number and/or expiration date may be illegible on the outer… Novartis Consumer Health Terminated
Class III August 28, 2013 Maalox Nighttime Antacid with Acid Reflux Barrier (calcium carbonate and alginic acid)… Labeling: Incorrect or Missing Lot and/or Exp Date: The lot number and/or expiration date may be illegible on the outer… Novartis Consumer Health Terminated
Class III August 28, 2013 Maalox Advanced Maximum Strength Antacid & Antigas (calcium carbonate and simethicone)… Labeling: Incorrect Or Missing Lot and/or Exp Date: The lot number and/or expiration date may be illegible on the outer… Novartis Consumer Health Terminated
Class III August 28, 2013 Maalox Extra Strength Antacid with Anti-Gas (calcium carbonate and simethicone) chewable… Labeling: Incorrect Or Missing Lot and/or Exp Date: The lot number and/or expiration date may be illegible on the outer… Novartis Consumer Health Terminated
Class III August 28, 2013 Maalox, Regular Strength Antacid (calcium carbonate) chewable tablets, 600 mg,… Labeling: Incorrect Or Missing Lot and/or Exp Date: The lot number and/or expiration date may be illegible on the outer… Novartis Consumer Health Terminated
Class II August 28, 2013 CLENZIderm M.D. Acne Therapeutic System Normal to Oily Skin kit, Distributed by OMP,… cGMP Deviations; during the production process, CLENZIderm M.D. Daily Foam Cleanser was filled into some bottles… Medicis Pharmaceutical Corp Terminated
Class III August 28, 2013 Maalox Extra Strength Antacid (calcium carbonate) chewable tablets,1000 mg, Wild Berry… Labeling: Incorrect Or Missing Lot and/or Exp Date: The lot number and/or expiration date may be illegible on the outer… Novartis Consumer Health Terminated
Class III August 28, 2013 Braintree HalfLytely and Bisacodyl Tablet Bowel Prep Kit (Rx) NDC 52268-523-02 Defective Container; Small micro fracture observed in the 2-Liter bottle at the fill line resulting in a small leak… Braintree Laboratories Inc. Terminated
Class III August 28, 2013 Maalox Regular Strength Antacid (calcium carbonate) chewable tablets, 600 mg, Wild Berry… Labeling: Incorrect Or Missing Lot and/or Exp Date: The lot number and/or expiration date may be illegible on the outer… Novartis Consumer Health Terminated
Class III August 28, 2013 Maalox Nighttime Antacid with Acid Reflux Barrier (calcium carbonate and alginic acid)… Labeling: Incorrect Or Missing Lot and/or Exp Date: The lot number and/or expiration date may be illegible on the outer… Novartis Consumer Health Terminated
Class III August 28, 2013 Mavik¿ trandolapril tablets 4mg, 100 count bottle, Rx only, Manufactured by Halo… Labeling: Incorrect Package Insert; product packaged with outdated version of the insert AbbVie Inc. Terminated
Class III August 28, 2013 NataChew, 1) one 90-count bottle of multi-vitamin tablets (imprinted 902), (NDC… Subpotent; Beta carotene (Vitamin A) Stayma Consulting Service, LLC. Terminated
Class II August 28, 2013 Nystatin Oral Suspension, USP 500,000 units/ 5 mL (NDC 66689-037-01 ) Rx Only,… Failed Impurites/Degradation Specifications: Test failure of single largest peak at 18 months. VistaPharm, Inc. Terminated
Class III August 28, 2013 Tagitol V Barium Sulfate Suspension (40% w/v, 30% w/w) Net Contents: 20 mL, (NDC… Failed Stability Specifications: Tagitol V Barium Sulfate Lot #65846 sampled at 10 months exhibited results above the… Bracco Diagnostics Inc Terminated