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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 September 23, 2015 Tri-Mix (20/1/10) Injectable, Sterile, Keep Frozen, The Compounding Pharmacy of America,… Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… The Compounding Pharmacy of America Terminated
Class II September 23, 2015 Morphine 50 mg/ml + Bupivacaine 2.5 mg/ml Solution, Sterile-Preservative Free, The… Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… The Compounding Pharmacy of America Terminated
Class II September 23, 2015 Testosterone 18 mg, Sterile Pellet, The Compounding Pharmacy of America, Knoxville, TN Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… The Compounding Pharmacy of America Terminated
Class II September 23, 2015 Morphine 50 mg/ml + Fentanyl 3,000 mcg/ml + Bupivacaine 15 mg/ml Solution, Sterile,… Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… The Compounding Pharmacy of America Terminated
Class II September 23, 2015 Hyaluronidase 150 units/ml Injection, ml, Sterile, Preserved, Refrigerate, The… Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… The Compounding Pharmacy of America Terminated
Class II September 23, 2015 Tri-Mix (30/0.5/10) Injectable, Sterile, Keep Frozen, The Compounding Pharmacy of… Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… The Compounding Pharmacy of America Terminated
Class II September 23, 2015 Morphine 50 mg/ml + Fentanyl 1,500 mcg/ml + Baclofen 800 mcg/ml +Clonidine 200 mcg/ml… Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… The Compounding Pharmacy of America Terminated
Class II September 23, 2015 Phosphatidylcholine 0.1% Sodium Deoxycholate 0.089% Injection, Vial, Sterile,… Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… The Compounding Pharmacy of America Terminated
Class II September 23, 2015 Hydromorphone 80 mg/ml + Fentanyl 15,000 mcg/ml + Bupivacaine 30 mg/ml + Baclofen 750… Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… The Compounding Pharmacy of America Terminated
Class II September 23, 2015 Hydromorphone 50 mg/ml + Fentanyl 3,000 mcg/ml + Bupivacaine 20 mg/ml Intrathecal… Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… The Compounding Pharmacy of America Terminated
Class II September 23, 2015 HCG 1,100 IU/ml Injection, Multi-Dose Vial, Sterile, Refrigerate The Compounding Pharmacy… Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… The Compounding Pharmacy of America Terminated
Class III September 23, 2015 IC-GREEN (indocyanine green for injection, USP), 25 mg Kit (NDC 17478-701-02, UPC 3… Subpotent Drug: Low out-of-specification potency result of the drug product. Akorn, Inc. Terminated
Class II September 23, 2015 Cevimeline Hydrochloride Capsules, 30 mg a) 100 count bottle, and b) 500 count bottle, Rx… Failed Stability Specifications: product may not meet specification limit for assay test. Apotex Inc. Terminated
Class II September 23, 2015 Ketamine Hydrochloride Injection, USP (100 mg/mL) packaged in 5 mL multi-dose glass… Defective Container: There were customer complaints of cracked and leaking glass vials. Hospira Inc. Terminated
Class III September 16, 2015 ImproVue Ophthalmic Lubricant Drops (1.7% Hypromellose), 1 Single Use Syringe, 0.07 fl oz… Falied pH specification Oasis Medical, Inc. Terminated
Class III September 16, 2015 Imipramine HCl Tablets, USP, 50 mg, 100 count bottles, Mfd By: Mutual Pharmaceutical Co.,… Chemical Contamination; benzophenone leached from the product label varnish Mutual Pharmaceutical Company, Inc. Terminated
Class II September 16, 2015 Ropivacaine HCl 0.2% in 100 mL total volume in a 100 mL Yellow Cassette Res. Flowstop in… Lack of Assurance of Sterility: The firm received a complaint of a sterility failure using a non-validated sterility… Pharmedium Services, LLC Terminated
Class II September 16, 2015 Surgicept (Ethyl alcohol 70% w/w) WATERLESS Surgical Hand Scrub & Healthcare Personnel… Chemical Contamination: Naphthalene compound identified in the product after complaints of a petroleum odor. Healthpoint, Ltd Terminated
Class III September 16, 2015 Imipramine HCl Tablets, USP, 25 mg, 100 count bottles, Mfd By: Mutual Pharmaceutical Co.,… Chemical Contamination; benzophenone leached from the product label varnish Mutual Pharmaceutical Company, Inc. Terminated
Class III September 16, 2015 METHOCARBAMOL TABLETS, USP 500 mg, 500 Count Bottles, Rx Only. Manufactured by… Presence of Foreign Substance: Presence of hair. Golden State Medical Supply Inc. Terminated
Class III September 16, 2015 CVS SUGAR FREE BLACK CHERRY COUGH DROPS (MENTHOL-COUGH SUPPRESSANT), Packaged in a) 25… Presence of Foreign Tablets/Capsules: Presence of comingled Sugar Free Honey Lemon cough drops. Bestco, Inc. Terminated
Class II September 16, 2015 DuraPrep Surgical Solution Iodine Povacrylex (0.7% Available Iodine) and Isopropyl… Chemical contamination: Product may be contaminated with a toxic compound. 3M Company - Health Care Business Terminated
Class III September 16, 2015 Imipramine HCl Tablets, USP, 10 mg, 100 count bottles, Rx only, Mfd By: Mutual… Chemical Contamination; benzophenone leached from the product label varnish Mutual Pharmaceutical Company, Inc. Terminated
Class III September 16, 2015 Felodipine Extended-Release Tablets, 2.5 mg, 100 count bottles, Rx only, Mutual… Chemical Contamination; benzophenone leached from the product label varnish Mutual Pharmaceutical Company, Inc. Terminated
Class III September 16, 2015 Felodipine Extended-Release Tablets, 5 mg, 100 count bottles, Rx only, Mutual… Chemical Contamination; benzophenone leached from the product label varnish Mutual Pharmaceutical Company, Inc. Terminated
Class III September 16, 2015 Felodipine Extended-Release Tablets, 10 mg, 100 count bottles, Rx only, Mutual… Chemical Contamination; benzophenone leached from the product label varnish Mutual Pharmaceutical Company, Inc. Terminated
Class II September 9, 2015 Bi-Est (estriol,estradiol), Progesterone Vaginal Suppository, Rx only, Manufactured by… Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin. South Coast Specialty Compounding, Inc. Terminated
Class II September 9, 2015 Artesunate Lyophilized Powder for Injection, 60 mg per vial, Rx only, Manufactured by… Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin. South Coast Specialty Compounding, Inc. Terminated
Class II September 9, 2015 Estradiol, Estriol, Progesterone capsules, Rx only, Manufactured by Park Compounding,… Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin. South Coast Specialty Compounding, Inc. Terminated
Class III September 9, 2015 Lamivudine Oral Solution, USP, 10 mg per 1 mL, 240 mL bottle (8 ounces), Rx only,… Labeling: Incorrect or Missing Lot and/or Exp. Date - Firm received a customer complaint that the expiration date… Silarx Pharmaceutical, Inc. Terminated
Class II September 9, 2015 Bi-Est 80:20 Progesterone (estriol,estradiol, progesterone) capsules, Rx only,… Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin. South Coast Specialty Compounding, Inc. Terminated
Class II September 9, 2015 Leucovorin Calcium capsules, 10 mg, Rx only, Manufactured by Park Compounding, Irvine, CA Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin. South Coast Specialty Compounding, Inc. Terminated
Class II September 9, 2015 Estriol,Estradiol cream, Rx only, Manufactured by Park Compounding, Irvine, CA Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin. South Coast Specialty Compounding, Inc. Terminated
Class II September 9, 2015 Bi-Est (estriol,estradiol), Progesterone, DHEA, Testosterone drops, Rx only, Manufactured… Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin. South Coast Specialty Compounding, Inc. Terminated
Class II September 9, 2015 Tri-Est 80:10:10 Progesterone (estriol, estradiol, estrone, progesterone) capsules Rx… Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin. South Coast Specialty Compounding, Inc. Terminated
Class II September 9, 2015 Meloxicam capsules, 12 mg, Rx Only, Manufactured by Park Compounding, Irving, CA… Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin. South Coast Specialty Compounding, Inc. Terminated
Class II September 9, 2015 Bi-Est (estriol,estradiol), Progesterone, Testosterone cream, Rx only, Manufactured by… Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin. South Coast Specialty Compounding, Inc. Terminated
Class II September 9, 2015 Lisinopril Tablets, USP, 40 mg, a) 45-count bottle (NDC 0603-4214-60), b) 500-count… Failed Dissolution Specifications Vintage Pharmaceuticals LLC dba Qualitest Pharmaceuticals Terminated
Class II September 9, 2015 Bi-Est (estriol,estradiol) Testosterone cream, Rx only, Manufactured by Park Compounding,… Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin. South Coast Specialty Compounding, Inc. Terminated
Class II September 9, 2015 Methyl Folate Lyophilized Powder for Injection, 20 mg per vial, Rx Only, Manufactured by… Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin. South Coast Specialty Compounding, Inc. Terminated
Class II September 9, 2015 Estradiol, Estriol capsules, Rx only, Manufactured by Park Compounding, Irvine, CA Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin. South Coast Specialty Compounding, Inc. Terminated
Class II September 9, 2015 Chorionic Gonadotropin/ Hydroxocobalamin Lyophilized Powder Injectable, 10,000 UNITS/… Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin. South Coast Specialty Compounding, Inc. Terminated
Class II September 9, 2015 Estradiol cream, Rx only, Manufactured by Park Compounding, Irvine, CA Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin. South Coast Specialty Compounding, Inc. Terminated
Class III September 9, 2015 Allopurinol ALLOPURINOL TABLETS, USP, 300 mg, 500 count bottle, Rx only, Manufactured for: QUALITEST… Failed Tablet/Capsule Specifications; report of oversized and discolored tablets Qualitest Pharmaceuticals Terminated
Class I September 2, 2015 EPINEPHrine HCl 4 mg added to 250 mL 0.9% Sodium Chloride Injection USP (16 mcg per mL),… Presence of Particulate Matter: The firm produced products using 0.9% Sodium Chloride Injection, USP or 5% Dextrose… Pharmedium Services, LLC Terminated
Class II September 2, 2015 Methadone 10 mg/mL Injection, 10 mL vial, Rx only, Liberty Drug Compound Center, 195 Main… Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products… Liberty Drug & Surgical Terminated
Class I September 2, 2015 oxyTOCIN 15 Units added to 250 mL 5% Dextrose Injection USP, packaged in 250 mL bags, Rx… Presence of Particulate Matter: The firm produced products using 0.9% Sodium Chloride Injection, USP or 5% Dextrose… Pharmedium Services, LLC Terminated
Class I September 2, 2015 EPINEPHrine HCl 1 mg added to 250 mL 0.9% Sodium Chloride Injection USP (4 mcg per mL),… Presence of Particulate Matter: The firm produced products using 0.9% Sodium Chloride Injection, USP or 5% Dextrose… Pharmedium Services, LLC Terminated
Class I September 2, 2015 HEPARIN Sodium Injection USP 25,000 USP Units added to 250 mL 5% Dextrose Injection USP… Presence of Particulate Matter: The firm produced products using 0.9% Sodium Chloride Injection, USP or 5% Dextrose… Pharmedium Services, LLC Terminated
Class II September 2, 2015 Papaverine/Phentolamine/PGE-1 Injectable, 20.8 mg/1.4 mg/14 mcg/mL, 2.5 mL vial, Rx only,… Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products… Liberty Drug & Surgical Terminated
Class II September 2, 2015 Tobramycin 14 mg/mL Ophthalmic Solution, 15 mL bottle, Rx only, Liberty Drug Compound… Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products… Liberty Drug & Surgical Terminated
Class I September 2, 2015 HEPARIN Sodium Injection USP, 12,500 USP Units added to 250 mL 5% Dextrose Injection USP… Presence of Particulate Matter: The firm produced products using 0.9% Sodium Chloride Injection, USP or 5% Dextrose… Pharmedium Services, LLC Terminated
Class II September 2, 2015 Phenol 6% Injectable, 30 mL vial, Rx only, Liberty Drug Compound Center, 195 Main St., PO… Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products… Liberty Drug & Surgical Terminated
Class II September 2, 2015 Bactroban Ointment (mupirocin calcium), 2% 22g tube ,Rx only, Manufactured by Glaxo… Penicillin Cross Contamination and Presence of Foreign Substance. Product was contaminated with penicillin and foreign… GlaxoSmithKline, LLC. Terminated
Class II September 2, 2015 Cyanocobalamin 500 mcg/mL Injectable, 1 mL pre-filled syringe, Rx only, Liberty Drug… Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products… Liberty Drug & Surgical Terminated
Class II September 2, 2015 Hydroxocobalamin (Preserved) 1,000 mcg/mL Injectable, 1 mL vial, Rx only, Liberty Drug… Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products… Liberty Drug & Surgical Terminated
Class I September 2, 2015 EPINEPHrine HCl 16 mg added to 250 mL 0.9% Sodium Chloride Injection USP (64 mcg per mL),… Presence of Particulate Matter: The firm produced products using 0.9% Sodium Chloride Injection, USP or 5% Dextrose… Pharmedium Services, LLC Terminated
Class II September 2, 2015 Methylcobalamin 1,000 mcg/mL Injectable, 1.5 mL vial, Rx only, Liberty Drug Compound… Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products… Liberty Drug & Surgical Terminated
Class I September 2, 2015 Mucinex Fast-Max Cold & Sinus, Maximum Strength, Acetaminophen Pain Reliever/Fever… Labeling: Label Mix-Up; Bottles of Mucinex Fast-Max liquid are correctly labeled on the front of the label, however the… Reckitt Benckiser LLC Terminated
Class I September 2, 2015 Mucinex Fast Max Severe Congestion & Cough, Maximum Strength, Dextromethorphan HBr Cough… Labeling: Label Mix-Up; Bottles of Mucinex Fast-Max liquid are correctly labeled on the front of the label, however the… Reckitt Benckiser LLC Terminated
Class II September 2, 2015 Methylcobalamin 5000 mcg/mL Injectable, 2 mL vial, Rx only, Liberty Drug Compound Center,… Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products… Liberty Drug & Surgical Terminated
Class II September 2, 2015 Mupirocin Calcium Cream, 2%, a) 15g tube (NDC 66993-942-15),b) 30g tube (NDC… Penicillin Cross Contamination and Presence of Foreign Substance. Product was contaminated with penicillin and foreign… GlaxoSmithKline, LLC. Terminated
Class II September 2, 2015 Doxycycline/0.9% NaCl 300 mg/500 mL IV, 500 mL bag, Rx only, Liberty Drug Compound… Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products… Liberty Drug & Surgical Terminated
Class III September 2, 2015 Phentermine Hydrochloride Capsules, USP, 15 mg, packaged in a) 100-count bottle (NDC… Failed Impurities/Degradation Specifications: out-of-specification results for individual unknown and total impurity at… KVK-Tech, Inc. Terminated
Class II September 2, 2015 Hydroxocobalamin (Preserved) 10,000 mcg/mL Injectable, 1 mL vial, Rx only, Liberty Drug… Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products… Liberty Drug & Surgical Terminated
Class II September 2, 2015 17-Hydroxyprogesterone 250 mg/mL Injectable, 5 mL multi-dose vial, Rx only, Liberty Drug… Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products… Liberty Drug & Surgical Terminated
Class II September 2, 2015 Papaverine/Phentolamine/PGE-1 Injectable, 10 mg/0.6 mg/10 mcg/mL, 2.5 mL vials, Rx only,… Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products… Liberty Drug & Surgical Terminated
Class II September 2, 2015 Vancomycin 25 mg/mL Opthalmic Solution, packaged in a) 10 mL bottle and b) 15 mL bottle,… Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products… Liberty Drug & Surgical Terminated
Class II September 2, 2015 Doxcycline/0.9% NaCl 150 mg/150 mL IV, 150 mL bag, Rx only, Liberty Drug Compound Center,… Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products… Liberty Drug & Surgical Terminated
Class I September 2, 2015 Mucinex Fast Max Day Time Severe Congestion & Cough Night Time Cold & Flu, Maximum… Labeling: Label Mix-Up; Bottles of Mucinex Fast-Max liquid are correctly labeled on the front of the label, however the… Reckitt Benckiser LLC Terminated
Class II September 2, 2015 Dexamethasone 24 mg/mL Injectable, 1 mL vial, Rx only, Liberty Drug Compound Center, 195… Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products… Liberty Drug & Surgical Terminated
Class II September 2, 2015 Papervine/Phentolamine/PGE-1 Injectable, 30 mg/0.5 mg/30 mcg/mL, 2.5 mL vial, Rx only,… Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products… Liberty Drug & Surgical Terminated
Class II September 2, 2015 Morphine/0.9 % NaCl 1 mg/mL IV, 250 mL bag, Rx only, Liberty Drug Compound Center, 195… Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products… Liberty Drug & Surgical Terminated
Class I September 2, 2015 ADRUCIL (fluorouracil injection, USP), 5 g/100 mL (50 mg/mL) glass vials, 5 x 100 ml… Presence of Particulate Matter: silcone rubber and fluorouracil crystals found floating in solution Teva Pharmaceuticals USA Terminated
Class II September 2, 2015 Papaverine/Phentolamine/Atropine/PGE-1 Injectable, 9 mg/1 mg/0.1 mg/10 mcg/mL, 2 mL vial,… Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products… Liberty Drug & Surgical Terminated
Class II September 2, 2015 Bactroban Cream (mupirocin calcium), 2%, a) 15g tube ( NDC 0029-1527-22), b) 30g tube… Penicillin Cross Contamination and Presence of Foreign Substance. Product was contaminated with penicillin and foreign… GlaxoSmithKline, LLC. Terminated
Class II September 2, 2015 Lidocaine/Sodium Chloride 0.4%/20% Injectable, 5 mL vial, Rx only, Liberty Drug Compound… Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products… Liberty Drug & Surgical Terminated
Class II September 2, 2015 Papaverine/Phentolamine/PGE-1 Injectable, 30 mg/1 mg/10 mcg/mL, 2.5 mL vial, Rx only,… Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products… Liberty Drug & Surgical Terminated
Class II September 2, 2015 Doxycycline/0.9 % NaCl 100 mg/100 mL IV, 100 mL bag, Rx only, Liberty Drug Compound… Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products… Liberty Drug & Surgical Terminated
Class II September 2, 2015 Bactroban (mupirocin calcium) Nasal Ointment, 2% 1g tube, Rx only, Manufactured by Glaxo… Penicillin Cross Contamination and Presence of Foreign Substance. Product was contaminated with penicillin and foreign… GlaxoSmithKline, LLC. Terminated
Class II September 2, 2015 Papaverine/Phentolamine/PGE-1 Injectable, 30 mg/2 mg/20 mcg/mL, 2.5 mL vial, Rx only,… Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products… Liberty Drug & Surgical Terminated
Class II September 2, 2015 Glycerin (v/v) 72% Injection, 25 mL vial, Rx only, Liberty Drug Compound Center, 195 Main… Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products… Liberty Drug & Surgical Terminated
Class II September 2, 2015 Papaverine/Phentolamine/Atropine/PGE-1 Injectable, 75 mg/2.5 mg/0.1 mg/75 mcg/mL, 2.5 mL… Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products… Liberty Drug & Surgical Terminated
Class II September 2, 2015 Doxycycline/0.9% NaCl 150 mg/250 mL IV, 250 mL bag, Rx only, Liberty Drug Compound… Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products… Liberty Drug & Surgical Terminated
Class I September 2, 2015 Mucinex Fast Max Day Time Severe Cold and Fast-Max Night Time Cold & Flu Two - 6 fl oz… Labeling: Label Mix-Up; Bottles of Mucinex Fast-Max liquid are correctly labeled on the front of the label, however the… Reckitt Benckiser LLC Terminated
Class I September 2, 2015 Mucinex Fast Max Night Time Cold & Flu, Maximum Strength, Acetaminophen Pain… Labeling: Label Mix-Up; Bottles of Mucinex Fast-Max liquid are correctly labeled on the front of the label, however the… Reckitt Benckiser LLC Terminated
Class III September 2, 2015 Topicort (desoximetasone) Topical Spray, 0.25%, 100 mL Bottles, Rx Only. Mfd by: Taro… Failed Impurities/Degradation Specifications: Out of specification results for impurities testing was obtained at the 6… Taro Pharmaceuticals, Inc. Terminated
Class II September 2, 2015 Hydrochlorothiazide Hydrochlorothiazide Tablet USP 25 mg,1000- count bottle, Rx Only, Manufactured by:… Presence of Foreign Tablet: A pharmacist found a clopidogrel tablet in the 1000-count bottle of hydrochlorothiazide 25… Unichem Pharmaceuticals Usa Inc Terminated
Class III September 2, 2015 Amlodipine besylate and Atorvastatin calcium Amlodipine besylate and Atorvastatin calcium Tablets, 5 mg/20 mg, Packaged in a) 30 Count… Subpotent Drug: Subpotent atorvastatin. Dr. Reddy's Laboratories, Inc. Terminated
Class III September 2, 2015 Amlodipine besylate and Atorvastatin calcium Amlodipine besylate and Atorvastatin calcium Tablets, 2.5 mg/20 mg, 30 Count Bottles, Rx… Subpotent Drug: Subpotent atorvastatin. Dr. Reddy's Laboratories, Inc. Terminated
Class II September 2, 2015 Mucinex Fast Max DM Max, Maximum Strength, Dextromethorphan HBr Cough Suppressant, 6 fl… Labeling: Label Mix-Up; Bottles of Mucinex Fast-Max liquid are correctly labeled on the front of the label, however the… Reckitt Benckiser LLC Terminated
Class III September 2, 2015 Amlodipine besylate and Atorvastatin calcium Amlodipine besylate and Atorvastatin calcium Tablets,2.5 mg/40 mg, 30 Count Bottles, Rx… Subpotent Drug: Subpotent atorvastatin. Dr. Reddy's Laboratories, Inc. Terminated
Class I September 2, 2015 Mucinex Fast Max Cold, Flu & Sore Throat, Maximum Strength, Acetaminophen Pain… Labeling: Label Mix-Up; Bottles of Mucinex Fast-Max liquid are correctly labeled on the front of the label, however the… Reckitt Benckiser LLC Terminated
Class III September 2, 2015 Amlodipine besylate and Atorvastatin calcium Amlodipine besylate and Atorvastatin calcium Tablets, 10 mg/80 mg, 30 Count Bottles, Rx… Subpotent Drug: Subpotent atorvastatin. Dr. Reddy's Laboratories, Inc. Terminated
Class III September 2, 2015 Amlodipine besylate and Atorvastatin calcium Amlodipine besylate and Atorvastatin calcium Tablets, 10 mg/20 mg, Packaged in a) 30… Subpotent Drug: Subpotent atorvastatin. Dr. Reddy's Laboratories, Inc. Terminated
Class III September 2, 2015 Amlodipine besylate and Atorvastatin calcium Amlodipine besylate and Atorvastatin calcium Tablets,10 mg/40 mg, Packaged in a) 30 Count… Subpotent Drug: Subpotent atorvastatin. Dr. Reddy's Laboratories, Inc. Terminated
Class III September 2, 2015 Amlodipine besylate and Atorvastatin calcium Amlodipine besylate and Atorvastatin calcium Tablets, 2.5 mg/10 mg, 30 Count Bottles, Rx… Subpotent Drug: Subpotent atorvastatin. Dr. Reddy's Laboratories, Inc. Terminated
Class III August 26, 2015 bupropion hydrochloride buPROPion Hydrochloride Extended-¿release Tablets USP (SR), 200 mg, Twice-A-Day, Rx Only,… Failed Dissolution Specification: During analysis of the 18 month long term stability testing, it was noticed that the… Sun Pharma Global Fze Terminated
Class II August 26, 2015 Lisinopril Tablets USP, 20 mg, 1000-count bottles, Rx Only, Manufactured by: Wockhardt… CGMP Deviations: An FDA inspection identified inadequate investigations of past market complaints. Wockhardt Usa Inc. Terminated
Class II August 26, 2015 univasc (moexipril HCl) tablets, 7.5 mg, 100 Ct Bottle, Rx Only. Manufactured for UCB,… Failed Dissolution Testing: Failed 24 month dissolution testing. Ucb, Inc Terminated
Class III August 26, 2015 AMPICILLIN CAPSULES, USP, 250 mg, 500 count bottles, Rx only, Manufactured for: DAVA… Labeling: Incorrect Or Missing Package Insert: Product is labeled with unapproved labeling. Vintage Pharmaceuticals LLC, DBA Qualitest Pharmaceuticals Terminated
Class I August 26, 2015 CARBOplatin Injection 450 mg/45 mL (10 mg/mL), 45 mL packaged in a 100 mL Multi-Dose… Presence of Particulate Matter Mylan Institutional LLC Terminated
Class I August 26, 2015 Gemcitabine for Injection, USP, 1 g*/vial, Lyophilized powder in a Single-Use Vial, Rx… Presence of Particulate Matter Mylan Institutional LLC Terminated
Class I August 26, 2015 Gemcitabine for Injection, USP, 2 g*/vial, Lyophilized powder in a Single-Use Vial, Rx… Presence of Particulate Matter Mylan Institutional LLC Terminated
Class II August 26, 2015 Bromfenac Ophthalmic Solution, 0.09%, 1.7 mL Bottle, Rx Only. Manufactured by Bausch &… Lack of Assurance of Sterility: Failed preservative effectiveness testing. Bausch & Lomb, Inc. Terminated
Class I August 26, 2015 Gemcitabine for Injection, USP, 200 mg*/vial, Lyophilized powder in a Single-Use Vial, Rx… Presence of Particulate Matter Mylan Institutional LLC Terminated
Class I August 26, 2015 PYROLA Advanced Joint Formula capsules, 60-count bottle, G & C Natural Nutrition Inc.,… Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared diclofenac, a prescription non-steroidal… GC Natural Nutrition, Inc. Terminated
Class II August 26, 2015 Lisinopril Tablets USP, 5 mg, 1000-count bottles, Rx Only, Manufactured by: Wockhardt… CGMP Deviations: An FDA inspection identified inadequate investigations of past market complaints. Wockhardt Usa Inc. Terminated
Class I August 26, 2015 SODIUM CHLORIDE 0.9% Sodium Chloride Injection USP, 50 mL Single Dose VIAFLEX Container bags, Rx only,… Presence of Particulate Matter: Customer complaint for an insect found free floating inside a single bag for each lot… Baxter Healthcare Corp. Terminated
Class I August 26, 2015 Sodium Chloride 0.9% Sodium Chloride Injection USP MINI-BAG Plus Container, 100 mL VIAFLEX Single Dose… Presence of Particulate Matter: Customer complaint for an insect found free floating inside a single bag for each lot… Baxter Healthcare Corp. Terminated
Class II August 19, 2015 SENSODYNE EXTRA FRESH COMPLETE PROTECTION, 3.4 oz.(96.4 g) tubes, Manufactured by… Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a toothbrush. GlaxoSmithkline Consmer Healthcare Terminated
Class II August 19, 2015 biotene Gentle Mint Gel, 4.5 oz.(127.6 g) tubes, Manufactured by Oratech, South Jordan,… Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a toothbrush. GlaxoSmithkline Consmer Healthcare Terminated
Class I August 19, 2015 Methotrexate Injection, USP 50 mg/2 mL (25 mg/mL), 2 mL Single-dose Vial, packaged in 5 x… Presence of Particulate Matter Mylan Institutional LLC Terminated
Class II August 19, 2015 biotene PBF Toothpaste (Plaque-Biofilm Loosening Formula), a) 4.3 oz. (121.9 g) tubes,… Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a toothbrush. GlaxoSmithkline Consmer Healthcare Terminated
Class II August 19, 2015 Rivastigmine Tartrate Rivastigmine Tartrate Capsules, USP 1.5 mg, 60 count bottle, Rx Only, Mfd. By Dr. Reddy's… Failed Dissolution Specifications Dr. Reddy's Laboratories, Inc. Terminated
Class I August 19, 2015 Cytarabine Injection 100 mg/5 mL (20 mg/mL), 5 mL Single-Dose Vial (NDC 0069-0152-01),… Presence of Particulate Matter Mylan Institutional LLC Terminated
Class II August 19, 2015 SENSODYNE WITH FLUORIDE REPAIR & PROTECT, a) 0.8 oz.(23 g) tubes, (NDC 0135-0548-01); b)… Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a toothbrush. GlaxoSmithkline Consmer Healthcare Terminated
Class II August 19, 2015 biotene Gentle Formula FLUORIDE TOOTHPASTE Fresh Mint Original, a) 0.70 oz (19.8 g)… Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a toothbrush. GlaxoSmithkline Consmer Healthcare Terminated
Class II August 19, 2015 SENSODYNE COMPLETE PROTECTION, 3.4 oz. (96.4 g)tubes, Manufactured by Oratech, South… Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a toothbrush. GlaxoSmithkline Consmer Healthcare Terminated
Class II August 19, 2015 biotene Gentle Formula FLUORIDE TOOTHPASTE GENTLE MINT , 4.3 oz.(121.9 g) tubes,… Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a toothbrush. GlaxoSmithkline Consmer Healthcare Terminated
Class II August 19, 2015 SENSODYNE EXTRA FRESH REPAIR & PROTECT, 3.4 oz. (96.4 g) tubes, Manufactured by Oratech,… Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a toothbrush. GlaxoSmithkline Consmer Healthcare Terminated
Class III August 19, 2015 HYDRALAZINE HYDROCHLORIDE Hydralazine Hydrochloride Injection, USP, 20 mg/mL, 1 mL fill, in a 2 mL; single dose… Incorrect Expiration Date: The "11/06" expiration date printed on the tray (secondary packaging) is incorrect (it… Fresenius Kabi USA, LLC Terminated
Class II August 19, 2015 SODIUM CHLORIDE 0.9% Sodium Chloride Injection USP, 500 mL in VIAFLEX Plastic Container, Baxter… Presence of Particulate Matter and Lack of Assurance of Sterility: The firm received a complaint for customer of… Baxter Healthcare Corp. Terminated
Class II August 12, 2015 S-Chorionic Gonad HCG 1000 U/mL Injection, Rx Only, 4 mL Vial, Apothecary Shoppe,… Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in… The Apothecary Shoppe LLC Terminated
Class II August 12, 2015 SIH-Testosterone Cyp. 20 mg/mL Injection, Rx Only, 10 mL Vial, Apothecary Shoppe,… Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in… The Apothecary Shoppe LLC Terminated
Class II August 12, 2015 SIU-Tri-Mix 24 mg/1 mg/10 mcg/mL, Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding… Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in… The Apothecary Shoppe LLC Terminated
Class II August 12, 2015 SIU-Tri-Mix 30/2/20 Inj., Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy,… Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in… The Apothecary Shoppe LLC Terminated
Class III August 12, 2015 Panadol (acetaminophen) Extra Strength, 500 mg, a) 30 count (UPC 1-03-53100-91070-8, NDC… Failed Dissolution Specifications GlaxoSmithkline Consmer Healthcare Terminated
Class II August 12, 2015 SIU-Papav/Phent 24/1 mg/mL Inj., Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding… Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in… The Apothecary Shoppe LLC Terminated
Class III August 12, 2015 Desmopressin Acetate Tablets, 0.1mg, 100 Count Bottles, Rx Only. Manufactured by: Actavis… Tablets/Capsules Imprinted with Wrong ID: Some tablets incorrectly imprinted with an X on one side. Actavis Laboratories, FL, Inc. Terminated
Class II August 12, 2015 SIU-Tri-Mix 17/0.6/5.7 Injectable, Rx Only, 5 mL Vial, Apothecary Shoppe, Compounding… Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in… The Apothecary Shoppe LLC Terminated
Class II August 12, 2015 SIU-Papav/Phent 30/1 mg Inj., Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding… Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in… The Apothecary Shoppe LLC Terminated
Class II August 12, 2015 SIU-Tri-Mix 30/1/10 Injection, Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding… Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in… The Apothecary Shoppe LLC Terminated
Class II August 12, 2015 SIU-Tri-Mix 30/1/20 Injectable, Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding… Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in… The Apothecary Shoppe LLC Terminated
Class II August 12, 2015 SIU-Prostaglandin E1 20 mcg/mL Injection, Rx Only, 10 mL Vial, Apothecary Shoppe,… Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in… The Apothecary Shoppe LLC Terminated
Class II August 12, 2015 SIU-Phent .8/PGE1 20 mcg/mL Inj., Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding… Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in… The Apothecary Shoppe LLC Terminated
Class II August 12, 2015 SIU-Tri-Mix 18/1/10 Injection, Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding… Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in… The Apothecary Shoppe LLC Terminated
Class II August 12, 2015 SIU-Papaverine 30 mg/mL Inj., Rx Only, 5 mL Vial, Apothecary Shoppe, Compounding… Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in… The Apothecary Shoppe LLC Terminated
Class III August 12, 2015 Mometasone Furoate Ointment USP, 0.1%, 15 g tubes, Rx Only, Manufactured by Perrigo,… Subpotent drug Perrigo Israel Pharmaceuticals Terminated
Class II August 12, 2015 SIU-Papav/Phentol 30/.5 mg/mL Injection, Rx Only, 3 mL Vial, Apothecary Shoppe,… Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in… The Apothecary Shoppe LLC Terminated
Class II August 12, 2015 SIU-Tri-Mix 18/1/20 Injection, Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding… Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in… The Apothecary Shoppe LLC Terminated
Class II August 12, 2015 SIU-Tri-Mix 6/0.33/3.33 Injection Solution, Rx Only, 3 mL Vial, Apothecary Shoppe,… Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in… The Apothecary Shoppe LLC Terminated
Class II August 12, 2015 SIH-Hydroxyprogesterone Caproate 250, Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding… Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in… The Apothecary Shoppe LLC Terminated
Class II August 12, 2015 S-Methylcobalamin 1000 mcg/mL (PF) Injection, Rx Only, 10 mL Vial, Apothecary Shoppe,… Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in… The Apothecary Shoppe LLC Terminated
Class II August 12, 2015 SIU-Prostaglandin E1 500 mcg/mL Injection, Rx Only, 10 mL Vial, Apothecary Shoppe,… Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in… The Apothecary Shoppe LLC Terminated
Class II August 12, 2015 SIH-Testosterone Cyp. 200 mg/mL Injection, Rx Only, 10 mL Vial, Apothecary Shoppe,… Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in… The Apothecary Shoppe LLC Terminated
Class II August 12, 2015 SO-Acetylcysteine 10% Sterile Ophthalmic Solution, Rx Only, 10 mL bottle, Apothecary… Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in… The Apothecary Shoppe LLC Terminated
Class II August 12, 2015 SIU-Papav/Phentol 30/1 mg/mL Injection, Rx Only, 5 mL Vial, Apothecary Shoppe,… Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in… The Apothecary Shoppe LLC Terminated
Class II August 12, 2015 SIU-Tri-Mix 20/1 mg/10 mcg/mL, Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding… Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in… The Apothecary Shoppe LLC Terminated
Class II August 12, 2015 SIU-Tri-Mix 24/1/20 Injection, Rx Only, 5 mL Vial, Apothecary Shoppe, Compounding… Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in… The Apothecary Shoppe LLC Terminated
Class II August 12, 2015 S-Methylcobalamin 5000 mcg/mL Inj., Rx Only, 750 mL Container, Apothecary Shoppe,… Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in… The Apothecary Shoppe LLC Terminated
Class II August 12, 2015 SIU-Phentolamine 5 mg/mL in Normal Saline, Rx Only, 10 mL Vial, Apothecary Shoppe,… Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in… The Apothecary Shoppe LLC Terminated
Class II August 12, 2015 S-methylcobalamin 25 mg/mL (PF) Injection, Rx Only, 10 mL Vial, Apothecary Shoppe,… Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in… The Apothecary Shoppe LLC Terminated
Class II August 12, 2015 SIU-Phent .4 mg/PGE1 20 mcg/mL Injection, Rx Only, 5 mL Vial, Apothecary Shoppe,… Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in… The Apothecary Shoppe LLC Terminated
Class III August 12, 2015 Nisoldipine Nisoldipine Extended Release Tablets, 17 mg, packaged as a) Sular (nisoldipine) Extended… Failed Dissolution Specifications Shionogi Inc. Terminated
Class II August 12, 2015 Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and… Failed Impurities/Degradation Specifications: out of specification for unknown impurity Teva Pharmaceuticals USA Terminated
Class II August 12, 2015 Absorica LD Absorica (isotretinoin) Capsules, 25 mg, Packaged in 3 x 10 Count Blister Cards/Box, Rx… Incorrect/Undeclared Excipients: Product contains undeclared FD&C Yellow No. 5 in the capsule shell. Ranbaxy Inc. Terminated
Class II August 5, 2015 Clonidine Hydrochloride Tablets, USP, 0.3 mg, 100 count HDPE bottles, Rx only, Mutual… cGMP Deviations; Clonidine hydrochloride drug substance used in the manufacturing of this product, was dispensed in… Mutual Pharmaceutical Company, Inc. Terminated
Class II August 5, 2015 Clonidine Hydrochloride Tablets, USP, 0.1 mg, packaged in a) 100 count (NDC 53489-215-01)… cGMP Deviations; Clonidine hydrochloride drug substance used in the manufacturing of this product, was dispensed in… Mutual Pharmaceutical Company, Inc. Terminated
Class II August 5, 2015 Clonidine Hydrochloride Tablets, USP, 0.2 mg, packaged in a) 100 count (NDC 53489-216-01)… cGMP Deviations; Clonidine hydrochloride drug substance used in the manufacturing of this product, was dispensed in… Mutual Pharmaceutical Company, Inc. Terminated
Class II August 5, 2015 COMBIVENT RESPIMAT (ipratropium bromide and albuterol) Inhalation Spray, 20 mcg/100 mcg… Defective Delivery System: Inhalers do not spray properly, emitting either no spray or a short transient spray. Boehringer Ingelheim Roxane Inc Terminated
Class II July 29, 2015 Metoprolol Succinate Extended-Release Tablets, USP, 50 mg Tablets, Packaged in A) 100… CGMP Deviations: Firm did not adequately investigate customer complaints. Wockhardt Usa Inc. Terminated
Class II July 29, 2015 Metoprolol Succinate Extended-Release Tablets, USP, 200 mg Tablets, Packaged in A) 100… CGMP Deviations: Firm did not adequately investigate customer complaints. Wockhardt Usa Inc. Terminated
Class II July 29, 2015 Lansoprazole Delayed-Release Capsules, USP, 15 mg Capsules, Packaged in 30 Count Bottles,… CGMP Deviations: Firm did not adequately investigate customer complaints. Wockhardt Usa Inc. Terminated
Class II July 29, 2015 Captopril Tablets, USP, 50 mg Tablets, Packaged in A) 100 Count Bottles (NDC:… CGMP Deviations: Firm did not adequately investigate customer complaints. Wockhardt Usa Inc. Terminated
Class II July 29, 2015 Extended Phenytoin Sodium Capsules, USP, 100 mg Capsules, Packaged as A) 100 Count… CGMP Deviations: Firm did not adequately investigate customer complaints. Wockhardt Usa Inc. Terminated
Class III July 29, 2015 Intermezzo (zolpidem tartrate), sublingual tablet 3.5 mg, 1 tablet per pouch, 30 pouches… Failed dissolution specifications Purdue Pharma L.P. Terminated
Class II July 29, 2015 Metoprolol Succinate Extended-Release Tablets, USP, 25 mg Tablets, Packaged in A) 100… CGMP Deviations: Firm did not adequately investigate customer complaints. Wockhardt Usa Inc. Terminated
Class II July 29, 2015 Zonisamide Capsules, 100 mg Capsules, Packaged in 100 Count Bottles, Rx Only.… CGMP Deviations: Firm did not adequately investigate customer complaints. Wockhardt Usa Inc. Terminated
Class II July 29, 2015 Lansoprazole Delayed-Release Capsules, USP, 15 mg Capsules, For Repackaging Only,… CGMP Deviations: Firm did not adequately investigate customer complaints. Wockhardt Usa Inc. Terminated
Class II July 29, 2015 Zolpidem Tartrate Tablets, 5 mg Tablets, CIV, Packaged in 100 Tablet Bottles, Rx only.… CGMP Deviations: Firm did not adequately investigate customer complaints. Wockhardt Usa Inc. Terminated
Class II July 29, 2015 Azithromycin Tablets, USP, 500 mg Tablets, Packaged in A) 30 Count Bottles (NDC:… CGMP Deviations: Firm did not adequately investigate customer complaints. Wockhardt Usa Inc. Terminated
Class II July 29, 2015 Azithromycin Tablets, USP, 600 mg Tablets, Packaged in 30 Count Bottles, Rx only.… CGMP Deviations: Firm did not adequately investigate customer complaints. Wockhardt Usa Inc. Terminated
Class II July 29, 2015 Lisinopril Tablets USP, 5 mg Tablets,Packaged in A) 100 Count Bottles (NDC:… CGMP Deviations: Firm did not adequately investigate customer complaints. Wockhardt Usa Inc. Terminated
Class II July 29, 2015 Lisinopril Tablets USP, 30 mg Tablets, Packaged in A) 100 Count Bottles (NDC:… CGMP Deviations: Firm did not adequately investigate customer complaints. Wockhardt Usa Inc. Terminated
Class II July 29, 2015 Famotodine Tablets, USP, 20 mg Tablets, Packaged in A) 30 Count Bottles (NDC:… CGMP Deviations: Firm did not adequately investigate customer complaints. Wockhardt Usa Inc. Terminated
Class II July 29, 2015 Clarithromycin Tablets, USP, 500 mg Tablets, 60 Count Bottles, Rx Only. Manufactured by:… CGMP Deviations: Firm did not adequately investigate customer complaints. Wockhardt Usa Inc. Terminated
Class II July 29, 2015 Famotodine Tablets, USP, 40 mg Tablets, Packaged in A) 30 Count Bottles (NDC:… CGMP Deviations: Firm did not adequately investigate customer complaints. Wockhardt Usa Inc. Terminated
Class II July 29, 2015 Lamotrigine Extended-Release Tablets, 25 mg Tablets, 30 Count Bottles, Rx Only.… CGMP Deviations: Firm did not adequately investigate customer complaints. Wockhardt Usa Inc. Terminated
Class II July 29, 2015 Captopril Tablets, USP, 25 mg Tablets, Packaged in A) 100 Count Bottles (NDC:… CGMP Deviations: Firm did not adequately investigate customer complaints. Wockhardt Usa Inc. Terminated
Class II July 29, 2015 Zonisamide Capsules, 50 mg Capsules, Packaged in 100 Count Bottles, Rx Only. Manufactured… CGMP Deviations: Firm did not adequately investigate customer complaints. Wockhardt Usa Inc. Terminated
Class II July 29, 2015 Lisinopril Tablets USP, 40 mg Tablets, Packaged in A) 100 Count Bottles (NDC:… CGMP Deviations: Firm did not adequately investigate customer complaints. Wockhardt Usa Inc. Terminated
Class II July 29, 2015 Azithromycin Tablets, USP, 250 mg Tablets, Packaged in A) 30 Count Bottles (NDC:… CGMP Deviations: Firm did not adequately investigate customer complaints. Wockhardt Usa Inc. Terminated
Class II July 29, 2015 Captopril Tablets, USP, 100 mg Tablets, Packaged in 100 Count Bottles, Rx only.… CGMP Deviations: Firm did not adequately investigate customer complaints. Wockhardt Usa Inc. Terminated
Class II July 29, 2015 Lansoprazole Delayed-Release Capsules, USP, 30 mg Capsules, Packaged in A) 30 Count… CGMP Deviations: Firm did not adequately investigate customer complaints. Wockhardt Usa Inc. Terminated
Class II July 29, 2015 Famotodine Tablets, USP, 20 mg Tablets, For Repacking Only, Packaged in 6500 Count Drums,… CGMP Deviations: Firm did not adequately investigate customer complaints. Wockhardt Usa Inc. Terminated
Class II July 29, 2015 Lisinopril Tablets USP, 20 mg Tablets, Packaged in A) 100 Count Bottles (NDC:… CGMP Deviations: Firm did not adequately investigate customer complaints. Wockhardt Usa Inc. Terminated
Class II July 29, 2015 Metoprolol Succinate Extended-Release Tablets, USP, 100 mg Tablets, Packaged in A) 100… CGMP Deviations: Firm did not adequately investigate customer complaints. Wockhardt Usa Inc. Terminated
Class II July 29, 2015 Zolpidem Tartrate Tablets, 10 mg Tablets, CIV, Packaged in A) 100 Count Bottles (NDC:… CGMP Deviations: Firm did not adequately investigate customer complaints. Wockhardt Usa Inc. Terminated
Class II July 29, 2015 Amlodipine Besylate Tablets, 10 mg Tablets, Packaged as A) 90 Count Bottles (NDC:… CGMP Deviations: Firm did not adequately investigate customer complaints. Wockhardt Usa Inc. Terminated
Class II July 29, 2015 Amlodipine Besylate Tablets, 2.5 mg Tablets, Packaged in 90 Count Bottles, Rx Only.… CGMP Deviations: Firm did not adequately investigate customer complaints. Wockhardt Usa Inc. Terminated
Class II July 29, 2015 Lisinopril Tablets USP, 2.5 mg Tablets, Packaged in A) 100 Count Bottles (NDC:… CGMP Deviations: Firm did not adequately investigate customer complaints. Wockhardt Usa Inc. Terminated
Class II July 29, 2015 Zonisamide Capsules, 25 mg Capsules, Packaged in 100 Count Bottles, Rx Only. Manufactured… CGMP Deviations: Firm did not adequately investigate customer complaints. Wockhardt Usa Inc. Terminated
Class II July 29, 2015 Amlodipine Besylate Tablets, 5 mg Tablets, Packaged as A) 90 Count Bottles (NDC:… CGMP Deviations: Firm did not adequately investigate customer complaints. Wockhardt Usa Inc. Terminated
Class II July 29, 2015 Famotodine Tablets, USP, 10 mg Tablets, For Repacking Only, Packaged in 50,000 Count… CGMP Deviations: Firm did not adequately investigate customer complaints. Wockhardt Usa Inc. Terminated
Class II July 29, 2015 Lisinopril Tablets USP, 10 mg Tablets, Packaged in A) 100 Count Bottles (NDC:… CGMP Deviations: Firm did not adequately investigate customer complaints. Wockhardt Usa Inc. Terminated
Class II July 29, 2015 Tamsulosin Hydrochloride Capsules, USP*, 0.4 mg Capsules, Packaged in A) 100 Count… CGMP Deviations: Firm did not adequately investigate customer complaints. Wockhardt Usa Inc. Terminated
Class III July 22, 2015 Desmopressin Acetate Tablets, 0.1 mg Tablets, Rx Only, Packed in 30 Tablet (3 x 10)… Tablets/Capsules Imprinted with Wrong ID: Some tablets incorrectly imprinted with an X on one side. American Health Packaging Terminated
Class III July 22, 2015 Carb-O-Philic 40 Cream, 40%, a) 3 oz. tube (NDC 54162-640-03) b) 7 oz. tube (NDC… CGMP Deviation: Poor container closure of the bulk storage container Geritrex Corp Terminated
Class III July 22, 2015 HydrOXYzine Hydrochloride Tablets, USP 25 mg, Rx only, 100 count (NDC 0603-3968-21), 500… Failed Tablet/Capsule Specifications; The identification codes on some tablets may be unreadable Qualitest Pharmaceuticals Terminated
Class II July 22, 2015 Rifampin Rifampin for Injection, USP 600mg/vial in a 20mL vial, Rx only, Manufactured for… Failed Impurities/Degradation Specifications; out-of-specification for color, impurity, and degradation Fresenius Kabi USA, LLC Terminated
Class II July 22, 2015 Nitroglycerin Transdermal System 0.2 mg/hr (10 cm2), For Transdermal Use Only, 30 Systems… Failed Impurities/Degradation Specifications: failed specification for unknown impurity at the 24 month stability… Kremers Urban Pharmaceuticals, Inc. Terminated
Class II July 22, 2015 0.9% Sodium Chloride Injection USP, 50 mL ADD-Vantage Unit, Rx only, Manufactured by… Lack of assurance of sterility: Potential channel leaks near the threaded vial port. Hospira Inc. Terminated
Class II July 22, 2015 Nitroglycerin Transdermal System 0.4 mg/hr (18 cm2), For Transdermal Use Only, 30 Systems… Failed Impurities/Degradation Specifications: Two lots failed specification for unknown impurity at the 24 month… Kremers Urban Pharmaceuticals, Inc. Terminated
Class II July 22, 2015 KETOROLAC TROMETHAMINE KETOROLAC Tromethamine Inj., USP, 60 mg (30 mg/mL), 2 mL Fill Single-dose Vials, I.V/I.M.… Crystallization; identified as calcium salt of Ketorolac Hospira Inc. Ongoing
Class II July 22, 2015 KETOROLAC TROMETHAMINE KETOROLAC Tromethamine Inj., USP, 30 mg (30 mg/mL), 1 mL Fill, Single-dose Vials,… Crystallization; identified as calcium salt of Ketorolac Hospira Inc. Ongoing
Class II July 15, 2015 Losartan potassium tablets USP, 25 mg, 90- count bottle, Rx only, Manufactured for Apotex… Failed Content Uniformity Specifications: The product may not meet the limit for blend uniformity specification. Apotex Inc. Terminated
Class II July 15, 2015 Amlodipine besylate tablets, USP 10 mg, packaged in 10-count blisters (NDC 68084-506-11);… CGMP Deviations: Firm did not adequately investigate customer complaints. American Health Packaging Terminated
Class II July 15, 2015 Losartan potassium tablets USP, 100 mg, 90-count bottle, Rx only, Manufactured for Apotex… Failed Content Uniformity Specifications: The product may not meet the limit for blend uniformity specification. Apotex Inc. Terminated
Class II July 15, 2015 Azithromycin tablets, USP 250mg, packaged in 10-count blisters (NDC 68084-278-11); 10… CGMP Deviations: Firm did not adequately investigate customer complaints. American Health Packaging Terminated
Class II July 15, 2015 Clarithromycin tablets, USP 500mg, packaged in 10-count blisters (NDC 68084-437-11); 5… CGMP Deviations: Firm did not adequately investigate customer complaints. American Health Packaging Terminated
Class II July 15, 2015 Capecitabine Tablets, USP, 500 mg, 120-count bottle, Rx only, Mylan Pharmaceuticals Inc.,… Failed Dissolution Specifications: low out-of-specification (OOS) results for dissolution were obtained at the… Mylan Pharmaceuticals Inc Terminated
Class III July 15, 2015 CORTISOL-MC, 10mg CAP, packaged in 30 and 90 count bottles, Rx Only, ABRAMS ROYAL… Failed Content Uniformity Specifications: Failed Uniformity of Dosage Units specifications. Abrams Royal Pharmacy II, LLC Terminated
Class II July 15, 2015 Lisinopril tablets, USP 10mg packaged in 10-count blisters (NDC 68084-061-11); 10 blister… CGMP Deviations: Firm did not adequately investigate customer complaints. American Health Packaging Terminated
Class II July 15, 2015 Enalapril maleate and hydrochlorothiazide tablets USP, 10/25 mg, 100-count bottle, Rx… Failed Content Uniformity Specifications: The product may not meet the limit for blend uniformity specification. Apotex Inc. Terminated
Class II July 15, 2015 Zonisamide capsules, USP 100mg packaged in 10-count blisters (NDC 68084-008-11); 5… CGMP Deviations: Firm did not adequately investigate customer complaints. American Health Packaging Terminated
Class II July 15, 2015 Lisinopril tablets, USP 40mg packaged in 10-count blisters (NDC 68084-064-11); 10 blister… CGMP Deviations: Firm did not adequately investigate customer complaints. American Health Packaging Terminated
Class II July 15, 2015 Azithromycin tablets, USP 600mg, packaged in 10-count blisters (NDC 68084-464-11); 3… CGMP Deviations: Firm did not adequately investigate customer complaints. American Health Packaging Terminated
Class I July 15, 2015 Adrucil (fluorouracil injection, USP) Pharmacy Bulk Package Not for Direct Infusion, 5… Presence of Particulate Matter: Black particulate matter was identified as aggregate of silicone rubber pieces from a… Teva Pharmaceuticals USA Terminated
Class II July 15, 2015 Amlodipine besylate tablets, USP 2.5mg, packaged in 10-count blisters (NDC 68084-498-11);… CGMP Deviations: Firm did not adequately investigate customer complaints. American Health Packaging Terminated
Class II July 15, 2015 Losartan potassium tablets USP, 50 mg, 90-count bottle, Rx only, Manufactured for Apotex… Failed Content Uniformity Specifications: The product may not meet the limit for blend uniformity specification. Apotex Inc. Terminated
Class II July 15, 2015 Lisinopril tablets, USP 5mg packaged in 10-count blisters (NDC 68084-060-11); 10 blister… CGMP Deviations: Firm did not adequately investigate customer complaints. American Health Packaging Terminated
Class III July 15, 2015 Magnesium Sulfate Injection, USP, 50%, 20mL, Single dose Fliptop Vial, For IV or IM use,… Failed pH Specifications: 12 month stability testing Hospira Inc. Terminated
Class II July 15, 2015 Lisinopril tablets, USP 20mg packaged in 10-count blisters (NDC 68084-062-11); 10 blister… CGMP Deviations: Firm did not adequately investigate customer complaints. American Health Packaging Terminated
Class II July 15, 2015 Azithromycin tablets, USP 500mg, packaged in 10-count blisters (NDC 68084-279-11); 3… CGMP Deviations: Firm did not adequately investigate customer complaints. American Health Packaging Terminated
Class I July 15, 2015 SLIM-K, 30 Capsules, barcode 160126417509, Distributed by: Bethel Inc. Marketed Without An Approved NDA/ANDA: Product was found to contain sibutramine, desmethylsibutramine and… Bethel Nutritional Consulting, Inc Terminated
Class II July 15, 2015 Famotidine tablets, USP 20mg, packaged in 10-count blisters (NDC 68084-172-11); 10… CGMP Deviations: Firm did not adequately investigate customer complaints. American Health Packaging Terminated
Class II July 15, 2015 Amlodipine besylate tablets, USP 5mg, packaged in 10-count blisters (NDC 68084-505-11);… CGMP Deviations: Firm did not adequately investigate customer complaints. American Health Packaging Terminated
Class III July 15, 2015 Maximum Strength Analgesic Thera-Gesic Pain Relieving Creme Relief from: Joint and Muscle… Subpotent Drug: menthol and methyl salicylate below specification BioComp Pharma, Inc. Terminated
Class I July 15, 2015 SODIUM CHLORIDE 0.9% Sodium Chloride Injection, USP, in 250mL VIAFLEX Plastic bags, Manufactured by… Presence of Particulate Matter: Products recalled due to presence of particulate matter (metal) Baxter Healthcare Corp. Terminated
Class I July 15, 2015 Bupivacaine Hydrochloride Bupivacaine Hydrochloride Inj., USP, 0.5% (5 mg/mL), Preservative-Free, 30 mL Single Use… Presence of Particulate Matter: Presence of free-floating and embedded iron oxide particles. Hospira Inc. Terminated
Class I July 15, 2015 Dextrose 5% Dextrose Injection, USP, 250mL VIAFLEX Plastic bags, Manufactured by Baxter Healthcare… Presence of Particulate Matter: Products recalled due to presence of particulate matter (metal) Baxter Healthcare Corp. Terminated
Class I July 15, 2015 Dextrose 10% Dextrose Injection, USP, 250mL VIAFLEX Plastic bags, Manufactured by Baxter… Presence of Particulate Matter: Products recalled due to presence of particulate matter (metal) Baxter Healthcare Corp. Terminated
Class I July 15, 2015 Lactated Ringers Lactated Ringers Injection, USP, 250mL VIAFELX Plastic bags, Manufactured by Baxter… Presence of Particulate Matter: Products recalled due to presence of particulate matter (metal) Baxter Healthcare Corp. Terminated
Class II July 8, 2015 CIPROFLOXACIN 400MG / D5W 200ML ACCUFLO, Packaged in 3 200 mL Bags, Rx Only. Compounded… Lack of Assurance of Sterility: Sterility of product is not assured. Lincare, Inc. Terminated
Class III July 8, 2015 Disulfiram tablets, USP, 500 mg, 100-count bottles, Rx only, Manufactured for and by… Failed Dissolution Specifications: During routine stability testing at the 12 month time point, one product lot was… Qualitest Pharmaceuticals Terminated
Class II July 8, 2015 GENTAMICIN 14.4 mg / NS 30 mL SYRINGE, Packaged in 30 mL Syringes, Rx Only. Compounded… Lack of Assurance of Sterility: Sterility of product is not assured. Lincare, Inc. Terminated
Class II July 8, 2015 TPN 3:1, 3000 mL Bags, Qty: 7, Base Formula Dextrose 70%, Travasol 10%, Intralipid 20%,… Lack of Assurance of Sterility: Sterility of product is not assured. Lincare, Inc. Terminated
Class II July 8, 2015 Fluorouracil 4600mg / D5W 292 mL, Qty: 1 292 mL Bag, Rx Only. Compounded by: United… Lack of Assurance of Sterility: Sterility of product is not assured. Lincare, Inc. Terminated
Class II July 8, 2015 CEFEPIME 1gm / NS 50mL AccuFlo, Packaged in 50 mL Bags, Rx Only. Compounded by: United… Lack of Assurance of Sterility: Sterility of product is not assured. Lincare, Inc. Terminated
Class II July 8, 2015 Fluorouracil 5760mg / D5W 265mL Qty: 1 265 mL Bag, Rx Only. Compounded by: United Medical… Lack of Assurance of Sterility: Sterility of product is not assured. Lincare, Inc. Terminated
Class II July 8, 2015 HYDROmorphone HCl PF, Hydromorphone 1000 mg / NS 500 mL, Qty: 1 500 mL Bag, Rx Only.… Lack of Assurance of Sterility: Sterility of product is not assured. Lincare, Inc. Terminated
Class II July 8, 2015 Fluorouracil 1400mg / D5W 278mL Qty: 1 278 mL Bag, Rx Only. Compounded by: United Medical… Lack of Assurance of Sterility: Sterility of product is not assured. Lincare, Inc. Terminated
Class II July 8, 2015 CEFTRIAXONE SODIUM 2000mg / NS 50mL, Qty:4 50 mL Bags, Rx Only. Compounded by: United… Lack of Assurance of Sterility: Sterility of product is not assured. Lincare, Inc. Terminated
Class II July 8, 2015 TPN 3:1, 2250 mL Bags, Qty: 5, Base Formula Sodium Chloride, Dextrose 70%, Clinisol SF… Lack of Assurance of Sterility: Sterility of product is not assured. Lincare, Inc. Terminated
Class II July 8, 2015 Fentanyl Citrate, FENTANYL 25,000 MCG / 500 ML, Qty: 1 500 mL Bag, Rx Only. Compounded… Lack of Assurance of Sterility: Sterility of product is not assured. Lincare, Inc. Terminated
Class II July 8, 2015 TPN 3:1, 2400 mL Bag, Qty: 6, Base Formula Sodium Chloride, Dextrose 70%, Travasol 10%,… Lack of Assurance of Sterility: Sterility of product is not assured. Lincare, Inc. Terminated
Class II July 8, 2015 TPN 3:1, 1800 ml Bags, Qty: 2, Base Formula NaCl 0.9%, Dextrose 70%, Travasol 10%,… Lack of Assurance of Sterility: Sterility of product is not assured. Lincare, Inc. Terminated
Class II July 8, 2015 Fluorouracil 3200mg / D5W 264mL, Qty: 1 264 mL Bag, Rx Only. Compounded by: United… Lack of Assurance of Sterility: Sterility of product is not assured. Lincare, Inc. Terminated
Class II July 8, 2015 Vancomycin HCl/Heparin, Vancomycin 50mcg/mL / Heparin 100u/mL, Qty: 3, Rx Only.… Lack of Assurance of Sterility: Sterility of product is not assured. Lincare, Inc. Terminated