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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 April 8, 2015 CLINIMIX E Clinimix E 5/20 sulfite-free (5% amino-acid with electrolytes in 20% dextrose with… Lack of Assurance of Sterility; increased complaints received for leaks Baxter Healthcare Corp Terminated
Class II April 8, 2015 SODIUM CHLORIDE 0.9% Sodium Chloride Injection, USP, 50 mL, VIAFLEX Plastic Container Multi Pack, Rx… Lack of Assurance of Sterility; increased complaints received for leaks Baxter Healthcare Corp Terminated
Class III April 1, 2015 Air AIR COMPRESSED, Medical Air, USP, Rx Only. Matheson Tri-Gas, Inc., 150 Allen Road,… Failed Impurities/Degradation Specification; out of specification results for carbon dioxide Matheson, Inc. Terminated
Class II April 1, 2015 B-Lipo, 30 Capsules, Manufactured by KM DALI, Kunming, China for Bethel Nutritional… Marketed without an Approved NDA/ANDA; found to contain Lorcaserin, a controlled substance used for weight loss Bethel Nutritional Consulting, Inc Terminated
Class II April 1, 2015 Hydroxocobalamin Injection Solution 1 mg/mL Inj., Rx, compounded by American Specialty… Presence of Particulate Matter; preservative may not have dissolved completely or precipitated out of product American Specialty Pharmacy Terminated
Class II April 1, 2015 Haloperidol Decanoate Haloperidol Decanoate Injection, 100 mg/mL, For Intra Muscular Use Only, 1 mL single dose… Lack of Assurance of Sterility; due to leaking vials Mylan Institutional LLC Terminated
Class II April 1, 2015 Haloperidol Decanoate Haloperidol Decanoate Injection, 50 mg/mL, For Intra Muscular Use Only, 1 mL single dose… Lack of Assurance of Sterility; due to leaking vials Mylan Institutional LLC Terminated
Class III April 1, 2015 Fentanyl Citrate Fentanyl Citrate Inj., USP, CII, 250 mcg/5 mL (50 mcg/mL) (0.05 mg/mL) 25 x 5 mL Single… Failed Impurities/Degradation Specifications; 12 month stability testing. West-Ward Pharmaceutical Corporation Terminated
Class II April 1, 2015 SODIUM CHLORIDE 0.9% Sodium Chloride Injection, USP, 500 mL in VIAFLEX Plastic Container, Rx only,… Lack of Assurance of Sterility. Complaints were receive of missing closures and/or leaks which may compromise product… Baxter Healthcare Corp. Terminated
Class II April 1, 2015 Dextrose 5% Dextrose Injection, USP, 1000mL in VIAFLEX Plastic Container, Rx only, Manufactured by… Lack of Assurance of Sterility. Complaints were receive of missing closures and/or leaks which may compromise product… Baxter Healthcare Corp. Terminated
Class II March 25, 2015 Antacid Liquid Regular Strength Antacid & Anti-Gas (Aluminum hydroxide 200 mg, Magnesium… Microbial Contamination of Non-Sterile Products: Lots failed microbiological testing at the 12-month time point. Tarmac Products, Inc. Terminated
Class II March 25, 2015 RIFAMPIN for Injection,USP, 600 mg per vial, Rx Only, Manufactured by: Emcure… Lack of Assurance of Sterility: Firm is recalling two injectable products due to concerns with quality control… Heritage Pharmaceuticals, Inc. Terminated
Class III March 25, 2015 Nicardipine Hydrochloride Injection, 25 mg/10 ml (2.5 mg/mL),10 mL single dose vial, Rx… Subpotent Drug and Failed Impurities/Degradation Specifications Mylan Institutional LLC Terminated
Class III March 25, 2015 DOXOrubicin Hydrochloride Injection, USP, 200 mg/100 mL (2 mg/mL), For IV Use Only,… Correct Labeled Product Mispack: Ifosfamide Injection 50 mg/mL, 60 mL, correctly labeled vial may have been… Mylan Institutional LLC Terminated
Class II March 25, 2015 Ergoloid Mesylates ,1 mg tablets, 100 count bottle, Rx only, Manufactured by MUTUAL… Failed Impurities/Degradation Specifications: during long-term stability testing. Mutual Pharmaceutical Company, Inc. Terminated
Class II March 25, 2015 COLISTIMETHATE SODIUM Colistimethate for Injection USP, 150 mg per vial, Rx Only, Manufactured by: Emcure… Lack of Assurance of Sterility: Firm is recalling two injectable products due to concerns with quality control… Heritage Pharmaceuticals, Inc. Terminated
Class II March 25, 2015 Dextrose 5% DEXTROSE Injection, USP, 250 mL ADD-Vantage Unit bag (NDC 0409-7100-02), UPC… Lack of Assurance of Sterility: there is a potential for solution to leak at the administrative port of the primary… Hospira Inc. Terminated
Class III March 18, 2015 Simvastatin Tablets, USP, 40mg, Rx Only, 90 count bottles, Manufactured by: Micro Labs… Failed Impurities/Degradation Specifications: Product failed a known impurity specification. Micro Labs Usa, Inc S Terminated
Class III March 18, 2015 Simvastatin Tablets, USP, 20mg a) 90- count bottle (42517-0020-10), b) 1000-count-bottle… Failed Impurities/Degradation Specifications: Product failed a known impurity specification. Micro Labs Usa, Inc S Terminated
Class II March 18, 2015 DICOPANOL (diphenhydramine hydrochloride in 5 mg/mL oral suspension kit) FusePaq, 150 mL… Microbial Contamination of a Non-Sterile Product: Kit component is contaminated with Burkholderia multivorans. Fusion Pharmaceuticals, LLC Terminated
Class II March 18, 2015 PROMETHAZINE DM SYRUP (Promethazine Hydrochloride, USP and Dextromethorphan Hydrobromide,… Presence of Foriegn Substance: Plastic cap closure particulates may be present in the product. Qualitest Pharmaceuticals Terminated
Class III March 18, 2015 Simvastatin Tablets, USP, 80mg, Rx Only, 90 count bottles, Manufactured by: Micro Labs… Failed Impurities/Degradation Specifications: Product failed a known impurity specification. Micro Labs Usa, Inc S Terminated
Class II March 11, 2015 Atracurium Besylate Injection, USP, 50 mg per 5 mL (10 mg per mL), Rx Only, 5 mL… Lack of Assurance of Sterility: Recall initiated due to FDA observations pertaining to aseptic and GMP practices at the… Sagent Pharmaceuticals Inc Terminated
Class II March 11, 2015 Fluticasone Propionate Nasal Spray, USP, 50 mcg per spray, in amber glass bottle with net… Failed Stability Specifications: Out of specification for preservative, benazalkonium chloride. Akorn, Inc. Terminated
Class III March 11, 2015 Z-COTE HP 1 TRANSPARENT ZINC OXIDE, Zinc Oxide (and) Triethoxycaprylylsilane, powder,… Labeling: Illegible label. Writing is rubbing off of labels. Nanophase Technologies Corporation Terminated
Class III March 11, 2015 Oxecta(TM) (oxycodone HCl) tablets, 7.5 mg, 100 count bottles, Rx only, Manufactured and… Failed Impurities/Degradation Specifications Pfizer Inc. Terminated
Class II March 11, 2015 Vancomycin Hydrochloride Capsules, USP, 125 mg, 2 x 10 count blister pack, Rx Only,… Subpotent Drug Actavis Inc Terminated
Class II March 11, 2015 AMLODIPINE BESYLATE TABLETS USP, 10 mg*, 1000 count bottles (NDC 0603-2110-32), Rx only,… Failed tablet specifications: One lot was found to contain oversized tablets. Qualitest Pharmaceuticals Terminated
Class III March 11, 2015 Quinapril Tablets USP, 5 mg, Rx only, 50 tablets (5 X 10) unit dose pack, Manufactured… Subpotent Drug AVKARE Inc. Terminated
Class III March 11, 2015 Oxecta(TM) (oxycodone HCl) tablets, 5 mg, 100 count bottles, Rx only, Manufactured and… Failed Impurities/Degradation Specifications Pfizer Inc. Terminated
Class II March 11, 2015 Atracurium Besylate Injection, USP, 100 mg per 10 mL (10 mg per mL), Rx Only, 10 mL… Lack of Assurance of Sterility: Recall initiated due to FDA observations pertaining to aseptic and GMP practices at the… Sagent Pharmaceuticals Inc Terminated
Class III March 11, 2015 Quinapril Tablets USP, 40 mg, Rx only, 50 tablets (5 X 10) unit dose pack, Manufactured… Subpotent Drug AVKARE Inc. Terminated
Class II March 11, 2015 Vancomycin Hydrochloride Capsules, USP, 250 mg, 2 x 10 count blister pack, Rx Only,… Subpotent Drug Actavis Inc Terminated
Class II March 11, 2015 dextroamphetamine sulfate Dextroamphetamine Sulfate Extended-Release Capsules, 15 mg, 90-count bottles, Rx Only,… Failed Dissolution Specifications Actavis Elizabeth LLC Terminated
Class II March 4, 2015 Ketorolac Tromethamine Ophthalmic Solution, 0.5%, 3 mL bottle, Rx only, Distributed by:… Presence of Particulate Matter: lot is not meeting the specification limit for number of particles present in the… Sun Pharma Global Fze Terminated
Class II March 4, 2015 Mafenide Acetate, USP, For 5% Topical Solution, STERILE, Net Wt. 50 grams sterile powder… Presence of Foreign Substance; oxidized steel, organic material and shredded polypropylene Par Pharmaceutical Inc. Terminated
Class I February 25, 2015 LACTATED RINGER'S and 5% DEXTROSE Injection USP, 1000 mL, flexible containers, Rx Only,… Non-Sterility: Confirmed customer complaint of particulate matter floating within the solution of the primary… Hospira Inc. Terminated
Class II February 25, 2015 Vancomycin Hydrochloride Vancomycin Hydrochloride for Injection, USP, 1 g Sterile Powder per Fliptop Vial,… Temperature Abuse: Products experienced uncontrolled temperature excursions during transit. Hospira Inc. Terminated
Class II February 25, 2015 KETOROLAC TROMETHAMINE Ketorolac Tromethamine Inj., USP, 60 mg (30 mg/mL), 2 mL Single-dose Fliptop Vial,… Temperature Abuse: Products experienced uncontrolled temperature excursions during transit. Hospira Inc. Terminated
Class I February 25, 2015 Lidocaine Hydrochloride 1% LIDOCAINE HCl Injection, USP, 10 mg/mL, 30 mL Single-dose, Preservative-Free glass… Presence of particulate matter: A returned customer sample was evaluated and found to have human hair attached to a… Hospira Inc. Terminated
Class II February 25, 2015 Vancomycin Hydrochloride Vancomycin Hydrochloride for Injection, USP, 500 mg Sterile Powder per Fliptop Vial,… Temperature Abuse: Products experienced uncontrolled temperature excursions during transit. Hospira Inc. Terminated
Class I February 25, 2015 propofol Propofol Injectable Emulsion, 1%, 200 mg/20 mL (10 mg/mL), 20 mL Single patient infusion… Temperature Abuse: Products experienced uncontrolled temperature excursions during transit. Hospira Inc. Terminated
Class II February 18, 2015 Levetiracetam, extended release tablets, 750 mg, 60-count bottle, Rx only, Manufactured… Failed Dissolution Specifications: 6 month time point. Sun Pharma Global Fze Terminated
Class II February 18, 2015 Erythromycin Pledgets USP, 2%, 60-count jar,Rx only, Manufactured by Ei LLC, Kannapolis,… Microbial Contamination of Non-Sterile Products: Active Pharmaceutical Ingredient (API) failed USP microbial tests. Akorn, Inc. Terminated
Class II February 18, 2015 Compounded Plaquex, intravenous injection, 50 ML vial. Each ml contains: Phosphatidyl… Good Manufacturing Practices Deviations: The product has an active pharmaceutical ingredient from an unapproved source. AnazaoHealth Corporation Terminated
Class II February 11, 2015 Children's Loratadine Syrup (Loratadine Oral Solution) 5 mg/5 mL, Antihistamine, Grape… Presence of Foreign Substance: Presence of blue plastic floating in loratadine syrup. Taro Pharmaceuticals U.S.A., Inc. Terminated
Class I February 11, 2015 Lidocaine Hydrochloride 1% LIDOCAINE HCl Injection, USP, Preservative-Free, 10 mg/mL, 30 mL Single-dose vials,… Presence of Particulate Matter: Confirmed customer complaint that orange and black particulates, identified as iron… Hospira Inc. Terminated
Class II February 4, 2015 propofol Propofol Injectable Emulsion, 1%, 200 mg/20 mL, (10mg/mL), 20 mL, Single patient infusion… Presence of Particulate Matter: The firm received a complaint of an embedded particulate in the neck of one vial… Hospira Inc. Terminated
Class II February 4, 2015 Fluconazole Fluconazole Injection, USP, 200 mg/100 mL (2 mg/mL), 100 mL Single-Dose INTRAVIA… Lack of Assurance of Sterility: Complaints of leaks due to an incomplete seal at the bag seam. Baxter Healthcare Corp. Terminated
Class II January 28, 2015 Total parenteral nutrition various strengths Lack of sterility assurance. Walgreens Infusion Services Terminated
Class III January 28, 2015 3M ESPE Clinpro 5000 (1.1% Sodium Flouride), Anti-Cavity Toothpaste, 4 oz tube (NDC… Labeling: Incorrect or Missing Lot and/or Exp. Date - The subject lot is missing the lot number and expiration date… 3M Company/3m Espe Dental Products Terminated
Class II January 28, 2015 Cefoxitin various strength in normal saline bags Lack of sterility assurance. Walgreens Infusion Services Terminated
Class II January 28, 2015 Cefazolin various strengths in normal saline bags Lack of sterility assurance. Walgreens Infusion Services Terminated
Class II January 28, 2015 Cefuroxime various strengths in normal saline bags Lack of sterility assurance. Walgreens Infusion Services Terminated
Class II January 28, 2015 Daptomycin various strengths in normal saline bags Lack of sterility assurance. Walgreens Infusion Services Terminated
Class II January 28, 2015 Imipenem/ cilastatin various strength in normal saline bags Lack of sterility assurance. Walgreens Infusion Services Terminated
Class II January 28, 2015 Liposomal Amphotericin B 130 mg in dextrose bags Lack of sterility assurance. Walgreens Infusion Services Terminated
Class II January 28, 2015 Nafcillin various strengths in sterile water for injection bags Lack of sterility assurance. Walgreens Infusion Services Terminated
Class II January 28, 2015 Caspofungin various strengths in normal saline Lack of sterility assurance. Walgreens Infusion Services Terminated
Class II January 28, 2015 Amikacin various strength in normal saline bags Lack of sterility assurance. Walgreens Infusion Services Terminated
Class II January 28, 2015 Linezolid various strengths in dextrose Lack of sterility assurance. Walgreens Infusion Services Terminated
Class II January 28, 2015 Dehydrated alcohol vials Lack of sterility assurance. Walgreens Infusion Services Terminated
Class II January 28, 2015 Tobramycin various strengths in normal saline bags Lack of sterility assurance. Walgreens Infusion Services Terminated
Class II January 28, 2015 Milrinone various strengths in dextrose Lack of sterility assurance. Walgreens Infusion Services Terminated
Class II January 28, 2015 Acyclovir various strengths in normal saline Lack of sterility assurance. Walgreens Infusion Services Terminated
Class II January 28, 2015 Piperacillin/ tazobactam various strength in normal saline bags Lack of sterility assurance. Walgreens Infusion Services Terminated
Class II January 28, 2015 CIPROFLOXACIN TABLETS, USP, 500 mg, 100 Tablets (10 tablets per blister card. 10 blister… CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to… Mylan Institutional, Inc. (d.b.a. UDL Laboratories) Terminated
Class II January 28, 2015 Folic acid 1 mg/ 0.2 ml pre-drawn syringes Lack of sterility assurance. Walgreens Infusion Services Terminated
Class II January 28, 2015 Dobutamine various strengths in dextrose Lack of sterility assurance. Walgreens Infusion Services Terminated
Class II January 28, 2015 Tigecycline various strengths in normal saline Lack of sterility assurance. Walgreens Infusion Services Terminated
Class II January 28, 2015 Magnesium sulfate various strengths in sodium chloride Lack of sterility assurance. Walgreens Infusion Services Terminated
Class II January 28, 2015 Gentamicin various strength in normal saline bags Lack of sterility assurance. Walgreens Infusion Services Terminated
Class II January 28, 2015 Aztreonam 1 gram in normal saline Lack of sterility assurance. Walgreens Infusion Services Terminated
Class II January 28, 2015 Thiamine 100 mg/ ml vials Lack of sterility assurance. Walgreens Infusion Services Terminated
Class II January 28, 2015 Dopamine various strengths in dextrose Lack of sterility assurance. Walgreens Infusion Services Terminated
Class II January 28, 2015 Ceftazidime various strength in normal saline bags Lack of sterility assurance. Walgreens Infusion Services Terminated
Class II January 28, 2015 Ertapenem various strength in normal saline bags Lack of sterility assurance. Walgreens Infusion Services Terminated
Class II January 28, 2015 Meropenem various strengths in normal saline bags Lack of sterility assurance. Walgreens Infusion Services Terminated
Class III January 28, 2015 Deferoxamine various strengths in normal saline Lack of sterility assurance. Walgreens Infusion Services Terminated
Class II January 28, 2015 Vancomycin various strengths in normal saline bags Lack of sterility assurance. Walgreens Infusion Services Terminated
Class II January 28, 2015 LAMOTRIGINE TABLETS, 200 mg, 100 Tablets (10 tablets per blister card x 10 blister cards… CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to… Mylan Institutional, Inc. (d.b.a. UDL Laboratories) Terminated
Class II January 28, 2015 Diphenhydramine 50 mg/ml vials Lack of sterility assurance. Walgreens Infusion Services Terminated
Class II January 28, 2015 Ceftriaxone various strengths in normal saline Lack of sterility assurance. Walgreens Infusion Services Terminated
Class II January 28, 2015 Immune globulin g human various strengths Lack of sterility assurance. Walgreens Infusion Services Terminated
Class II January 28, 2015 L-cysteine various strengths Lack of sterility assurance. Walgreens Infusion Services Terminated
Class II January 28, 2015 Ranitidine various strengths in syringes Lack of sterility assurance. Walgreens Infusion Services Terminated
Class II January 28, 2015 Levofloxacin various strengths in normal saline Lack of sterility assurance. Walgreens Infusion Services Terminated
Class II January 28, 2015 Cefepime various strengths in normal saline Lack of sterility assurance. Walgreens Infusion Services Terminated
Class II January 28, 2015 Virazole (Ribavirin for Inhalation Solution, USP), Sterile Lyophilized For Administration… Non-Sterility: Valeant's laboratory observed a positive microbial contamination of Virazole lot 340353F, during testing… Valeant Pharmaceuticals North America LLC Terminated
Class II January 21, 2015 Glycopyrrolate injection, 0.2 mg per mL (1 mg/5 mL), 5 mL Fill in 10 mL Syringe, Rx Only,… Labeling: Incorrect or missing Lot and/or Exp Date: Printing error caused an overlap in the "y" and "3" making the… SCA Pharmaceuticals Terminated
Class II January 14, 2015 Gabapentin Capsules, USP, 300 mg, Rx Only, 100 capsules per bottle, Manufactured by:… Failed Capsule/Tablet Specifications: Actavis has received several complaint for clumping and breaking of capsules with… Actavis Elizabeth LLC Terminated
Class III January 14, 2015 Triamcinolone Acetonide Lotion USP, 0.025% is supplied in the following size: 60 mL (NDC… Failed Impurities/Degradation Specifications: The known impurity went out of specification at 12 months stability point. Akorn, Inc. Terminated
Class II January 14, 2015 HydrALAZINE Hydrochloride Tablets, USP 25 mg, 100 count bottle Rx only, Distributed by:… Presence of Foreign Substance: Par Pharmaceutical, Inc. is recalling one lot of HydrALAZINE Hydrochloride tablets due… Par Pharmaceutical Inc. Terminated
Class II January 14, 2015 0.9% Sodium Chloride Injection, USP, 100mL, VisIV Container, Rx only, Hospira Inc., Lake… Lack of Assurance of Sterility: The product has the potential for solution to leak at the administrative port. Hospira Inc. Terminated
Class II January 14, 2015 Glutathione 200 mg/mL Injectable, packaged in a) 5 mL MDV (multiple dose vials), b) 30 mL… Incorrect Product Formulation: An incorrect gas was used to remove the oxygen from the vial. Right Value Drug Stores, Inc. Terminated
Class III January 14, 2015 ACETAMINOPHEN and CODEINE PHOSPHATE ORAL SOLUTION USP, 120 mg/12 mg per 5 mL, packaged in… Failed Impurities/Degradation Specifications: High out of specification results for the known impurity p-Aminophenol. Qualitest Pharmaceuticals Terminated
Class II January 14, 2015 Gabapentin Gabapentin Capsules, USP 300 mg, 100-count bottles, Rx only, Manufactured for: Northstar… Failed Tablet/Capsule Specifications: Complaints of empty capsules received. Aurobindo Pharma USA Inc Terminated
Class II January 14, 2015 Gabapentin Gabapentin Capsules, USP, 100 mg, Rx Only, a) 100 capsules per bottle, NDC 45963-555-11,… Failed Capsule/Tablet Specifications: Actavis has received several complaint for clumping and breaking of capsules with… Actavis Elizabeth LLC Terminated
Class II January 14, 2015 Gabapentin Gabapentin Capsules, USP, 400 mg, Rx Only, a) 100 capsules per bottle, NDC 14550-513-02,… Failed Capsule/Tablet Specifications: Actavis has received several complaint for clumping and breaking of capsules with… Actavis Elizabeth LLC Terminated
Class II January 7, 2015 GINSENG KIANPI PIL, 60 capsules, PRODUCT OF KWEILIN DRUG MANUFACTORY Marketed Without An Approved NDA/ANDA: FDA analysis found this product to contain undeclared dexamethasone and… One and Zen Terminated
Class II January 7, 2015 J-TAN D PD Drops (bromphenirame maleate 1 mg and pseudoephedrine hcl 7.5 mg/ teaspoon), 1… Labeling: Not Elsewhere Classified: Product is labeled "Dye Free" on front panel but contains Red Dye 40. Jaymac Pharmaceuticals L.L.C. Terminated
Class II January 7, 2015 Entertainer's Secret Throat Relief, 2.0 FL oz (59.2 mL), Honey Apple Flavor, KLI Corp,… Microbial Contamination of Non Sterile Product; microbial assay reported unacceptable high plate counts and positive… Tropichem Research Labs, Inc. Terminated
Class I December 31, 2014 Magnesium Chloride 20% (200mg/mL) Sterile Injection, 50mL Multi-Dose Vial, Rx only,… Non-Sterility: Failing sterility results were obtained from the recalling firm's contract testing facility indicating… Pharmacy Creations Terminated
Class III December 31, 2014 Eye Drops A.C. (Tetrahydrozoline HCl 0.05%, Zinc sulfate 0.25%), 0.5 FL OZ (15 mL)… CGMP Deviations: Active Pharmaceutical Ingredient (API) used for manufacture was stored in a non-GMP compliant… K C Pharmaceuticals Inc Terminated
Class I December 31, 2014 Glutathione 100mg/mL Sterile Injection, 30 mL Multi Dose Vial, Rx only, Pharmacy… Non-Sterility: Failing sterility results were obtained from the recalling firm's contract testing facility indicating… Pharmacy Creations Terminated
Class I December 31, 2014 Esmeralda, bottle contains 30 Softgels, product is packaged in a white plastic bottle… Marketed without an approved NDA/ANDA - New Life Nutritional Center is recalling SUPER FAT BURNER, MAXI GOLD WEIGHT… New Life Nutritional Center Terminated
Class III December 31, 2014 Dacarbazine, Injection, USP, 200mg, vials packaged in individual cartons, Rx only,… Discoloration: Reconstituted solution may appear pink instead of colorless to pale yellow when stored per the labeled… Hospira Inc. Terminated
Class II December 31, 2014 Epinephrine 1:1000, 0.15 mL packaged in 0.3 mL syringes, Rx, Vann Healthcare Pharmacy,… Lack of Assurance of Sterility: A recent FDA inspection of Vann Healthcare Services facility revealed deficiencies that… Vann Healthcare Services Inc Terminated
Class I December 31, 2014 New Life Nutritional SUPER FAT BURNER, bottle contains 30 CAPSULES, product is packaged… Marketed without an approved NDA/ANDA - New Life Nutritional Center is recalling SUPER FAT BURNER, MAXI GOLD WEIGHT… New Life Nutritional Center Terminated
Class II December 31, 2014 MAYHEM capsules, Proprietary Blend 525 mg, Dietary Supplement, 60-count bottles,… Marketed Without An Approved NDA/ANDA: FDA analysis found this product to contain undeclared dexamethasone and… Chaotic Labz Terminated
Class II December 31, 2014 Hydroxyprogesterone Caproate, 250 mg per mL, 5 mL vial, Rx, Vann Healthcare Pharmacy,… Lack of Assurance of Sterility: A recent FDA inspection of Vann Healthcare Services facility revealed deficiencies that… Vann Healthcare Services Inc Terminated
Class III December 31, 2014 Eye Drops Industrial Strength (Polyethylene glycol 400 1%, Tetrahydrozoline HCl 0.05%),… CGMP Deviations: Active Pharmaceutical Ingredient (API) used for manufacture was stored in a non-GMP compliant… K C Pharmaceuticals Inc Terminated
Class II December 31, 2014 Lidocaine 4% Syr (PF) Rx, 1 mL packaged in 3 mL syringes, Vann Healthcare Pharmacy, 1220… Lack of Assurance of Sterility: A recent FDA inspection of Vann Healthcare Services facility revealed deficiencies that… Vann Healthcare Services Inc Terminated
Class I December 31, 2014 Tropi/Cyclo/Phenyl/Tobra/Flurb (1/1/10/0.3/0.03)% Sterile Ophthalmic Solution, 1 mL… Non-Sterility: Failing sterility results were obtained from the recalling firm's contract testing facility indicating… Pharmacy Creations Terminated
Class III December 31, 2014 sulfur8(R) medicated anti-dandruff conditioner, dandruff treatment for Braids, spray,… Failed pH specification: Product pH test value of 5.72 failed to meet its product specification of 6.0 to 7.5. J. Strickland and Co Terminated
Class I December 31, 2014 Ascorbic Acid 500 mg/mL Sterile Injection, 50mL Multi-dose Vial, Rx only, Pharmacy… Non-Sterility: Failing sterility results were obtained from the recalling firm's contract testing facility indicating… Pharmacy Creations Terminated
Class II December 31, 2014 Tri-mix #4 (Papaverine 30 mg, Phentolamine 1 mg, Prostaglandin-1 10 mcg/mL), packaged in… Lack of Assurance of Sterility: A recent FDA inspection of Vann Healthcare Services facility revealed deficiencies that… Vann Healthcare Services Inc Terminated
Class I December 31, 2014 MAXI GOLD WEIGHT LOSS PILL, bottle contains 30 CAPSULES, product is packaged in a clear… Marketed without an approved NDA/ANDA - New Life Nutritional Center is recalling SUPER FAT BURNER, MAXI GOLD WEIGHT… New Life Nutritional Center Terminated
Class II December 31, 2014 Walgreens ASPIRIN FREE TENSION HEADACHE, Pain Reliever/Pain Reliever Aid, Acetaminophen &… Incorrect/Undeclared Excipients: The firm recalled specific lots of Walgreens brand Aspirin Free Tension Headache… LNK International, Inc. Terminated
Class II December 31, 2014 Alprazolam Alprazolam tablets, USP, CIV, 0.25 mg, Rx Only, a) 500 count bottle, b) 1000 count… Subpotent Drug Neolpharma, Inc. Terminated
Class I December 31, 2014 Heparin Sodium HEPARIN SODIUM, 1000 USP Heparin Units/500 mL (2 USP Heparin Units/mL), in 0.9% Sodium… Presence of Particulate Matter: A particulate, confirmed as human hair, was found sealed between the tube and film at… Hospira Inc. Terminated
Class III December 31, 2014 Eye Drops Advanced Relief (Dextran 70 0.1%, Polyethylene glycol 400 1%, Povidone 1%,… CGMP Deviations: Active Pharmaceutical Ingredient (API) used for manufacture was stored in a non-GMP compliant… K C Pharmaceuticals Inc Terminated
Class III December 31, 2014 Eye Drops (Tetrahydrozoline HCl 0.05%), 0.5 FL OZ (15 mL) Bottles, Over the Counter.… CGMP Deviations: Active Pharmaceutical Ingredient (API) used for manufacture was stored in a non-GMP compliant… K C Pharmaceuticals Inc Terminated
Class II December 31, 2014 Benzonatate Benzonatate Capsules, USP, 100 mg, Rx only, Manufactured by: Cadila Healthcare Ltd,… Failed Tablet/Capsule Specifications: Recall due to wet and/or leaking capsules. Zydus Pharmaceuticals USA Inc Terminated
Class II December 24, 2014 Mercaptopurine Tablets, USP, 50 mg, 30 Tablets (3 x 10) unit dose blisters per carton, Rx… Failed USP Dissolution Test Requirements: This sub-recall is in response to Prometheus Laboratories Inc. recall for… American Health Packaging Terminated
Class II December 24, 2014 Meropenem I.V. 1 g is supplied in 30 mL injection vials, RX only. Manufactured by Hospira… Defective Container: Glass vials may crack due to low (thin) out of specification vial wall thickness which may lead to… Hospira Inc. Terminated
Class II December 24, 2014 Benzonatate Capsules, USP, 200 mg, 100-count bottles, Rx only, Manufactured by: Cadila… Failed Tablet/Capsule Specifications: Recall due to wet and/or leaking capsules. Zydus Pharmaceuticals USA Inc Terminated
Class III December 24, 2014 BELVIQ¿ (Lorcaserin HCl) Tablets, 10 mg, 60-count bottle, Rx only, Manufactured by: Arena… Labeling:Missing Label: Bottles may not have a product label, or have a label with missing or illegible lot number… Eisai Inc Terminated
Class III December 24, 2014 Wockhardt Metoprolol Succinate, Extended-Release Tablets USP, 50 mg, a)100-count HDPE… Failed Dissolution Specifications: Product was out of specification (OOS) at the 12 month long term stability testing… Wockhardt Usa Inc. Terminated
Class II December 24, 2014 CLINIMIX E Clinimix E 4.25/10 sulfite-free (4.25% Amino Acid with Electrolytes in 10% Dextrose with… Lack of Assurance of Sterility; leaks were observed from the bag seam and port seal Baxter Healthcare Corp. Terminated
Class II December 17, 2014 Gentamicin GENTAMICIN INJECTION, USP, equivalent to 40 mg/mL, Rx only, 20 mL Multiple Dose Vial,… Defective Container: Vials may be missing stoppers. Fresenius Kabi USA, LLC Terminated
Class III December 17, 2014 Fluoxetine Capsules USP, 20 mg, 100 count bottle, Rx Only, 100 Capsules, Sandoz Inc… Labeling: Illegible Label: Sandoz Inc. is recalling of one lot of Fluoxetine Capsules due to an illegible logo on the… Sandoz Incorporated Terminated
Class III December 17, 2014 Scrub Care Chlorhexidine Gluconate Solution, 4% Surgical Hand Scrub, OTC, CareFusion,… Does Not Meet Monograph: Chlorhexidine Gluconate Surgical Scrub Brush is being recalled due to higher concentrations of… CareFusion 213, LLC Terminated
Class II December 17, 2014 Ondansetron ONDANSETRON INJECTION, USP, 4 mg/ 2 mL (2 mg/mL), For IM or IV Use, Single Dose 2 mL… Lack of Assurance of Sterility: Glass vials may have finish fractures and glass particles. Fresenius Kabi USA, LLC Terminated
Class II December 17, 2014 Cyanocobalamin CYANOCOBALAMIN INJECTION, USP, 1000 mcg/mL, For IM or IV Use, Multiple Dose 2 mL Vials,… Lack of Assurance of Sterility: Glass vials may have finish fractures and glass particles. Fresenius Kabi USA, LLC Terminated
Class II December 17, 2014 Famotidine Famotidine Injection 20 mg, Rx Only, GALAXY Single Dose Container, Code 2G3424, Sterile… Presence of Particulate Matter: Baxter Healthcare Corporation has received a complaint reporting the presence of… Baxter Healthcare Corp. Terminated
Class II December 17, 2014 Fentanyl Citrate Fentanyl Citrate Injection, USP, 2500 mcg Fentanyl/50 mL, 50 mL Single-dose Flip top Vial… Lack of Assurance of Sterility; improperly crimped fliptop vials Hospira Inc. Terminated
Class II December 17, 2014 Tikosyn Tikosyn (dofetilide) 125 mcg (0.125 mg), a) 14-count bottle (NDC 0069-5800-61), b)… Failed Tablet/Capsule Specifications: Product being recalled due to the potential presence of cracked or broken… Pfizer Inc. Terminated
Class II December 17, 2014 Midazolam MIDAZOLAM HYDROCHLORIDE INJECTION, 5 mg/1 mL, C-IV, For IM or IV Use, 2 mL Vials, Rx… Lack of Assurance of Sterility: Glass vials may have finish fractures and glass particles. Fresenius Kabi USA, LLC Terminated
Class III December 10, 2014 BENZONATATE Capsules, USP, 200 mg, 100 Capsule Bottles, Rx only. Manufactured by: Cadila… Presence of Foreign Capsules/Tablets: Benzonatate 100 mg co-mingled with benzonatate 200 mg capsules. Zydus Pharmaceuticals USA Inc Terminated
Class III December 10, 2014 candesartan cilexetil, tablets, 16 mg, 90-count bottles, Rx only, Manufactured for Sandoz… Failed Impurities/Degradation Specifications: An Out of Specification (OOS) result was generated for the 18 month… Sandoz, Inc Terminated
Class II December 3, 2014 5% Dextrose and 0.9% Sodium Chloride Injection, USP, 1000 mL container, Rx Only,… Lack of Assurance of Sterility: Potential of punctures through the overwrap and primary container which may result in… Hospira Inc. Terminated
Class II December 3, 2014 HCG Low Dose 10 IU / 0.1 mL, 5 Ml vials, Compounded Rx, Perry Drug Compounding Pharmacy,… Lack of sterility assurance;All lots of sterile products compounded by the pharmacy that are within expiry were… Perry Drug Inc. Terminated
Class II December 3, 2014 Testosterone Cyp 200 mg/mL Sesame Inj., 4Ml Syringes, Compounded Rx, Perry Drug… Lack of sterility assurance;All lots of sterile products compounded by the pharmacy that are within expiry were… Perry Drug Inc. Terminated
Class II December 3, 2014 Normosol-R Multiple Electrolytes Injection Type 1, USP, 1000 mL container, Rx Only,… Lack of Assurance of Sterility: Potential of punctures through the overwrap and primary container which may result in… Hospira Inc. Terminated
Class II December 3, 2014 HCG 10,000 U/ 10 mL PF Inj, 8Ml vials, Compounded Rx, Perry Drug Compounding Pharmacy,… Lack of sterility assurance;All lots of sterile products compounded by the pharmacy that are within expiry were… Perry Drug Inc. Terminated
Class II December 3, 2014 HCG - 10,000 Unit PF Inject, 1mL Syringe, Compounded Rx, Perry Drug Compounding Pharmacy,… Lack of sterility assurance;All lots of sterile products compounded by the pharmacy that are within expiry were… Perry Drug Inc. Terminated
Class II December 3, 2014 5% Dextrose and 0.45% Sodium Chloride Injection, USP, 1000 mL container, Rx Only,… Lack of Assurance of Sterility: Potential of punctures through the overwrap and primary container which may result in… Hospira Inc. Terminated
Class II December 3, 2014 Cyclosporine 0.045 % Sol PF, 12 mL bottle, Rx, Perry Drug Compounding Pharmacy, Overland… Lack of sterility assurance;All lots of sterile products compounded by the pharmacy that are within expiry were… Perry Drug Inc. Terminated
Class II December 3, 2014 5% Dextrose Injection, USP, 1000 mL container, Rx Only, Manufactured by Hospira, Inc.,… Lack of Assurance of Sterility: Potential of punctures through the overwrap and primary container which may result in… Hospira Inc. Terminated
Class II December 3, 2014 Sodium Tetradecyl SO4 0.3% Inj., 30 Ml vials, Compounded Rx, Perry Drug Compounding… Lack of sterility assurance;All lots of sterile products compounded by the pharmacy that are within expiry were… Perry Drug Inc. Terminated
Class II December 3, 2014 Potassium Chloride in 5% Dextrose and 0.45% Sodium Chloride Injection, USP, 1000 mL… Lack of Assurance of Sterility: Potential of punctures through the overwrap and primary container which may result in… Hospira Inc. Terminated
Class II December 3, 2014 Leuprolide 50 mcg/0.1 mL Micro Lupron Kit, 5Ml, Compounded Rx, Perry Drug Compounding… Lack of sterility assurance;All lots of sterile products compounded by the pharmacy that are within expiry were… Perry Drug Inc. Terminated
Class II December 3, 2014 0.9% Sodium Chloride Injection, USP, 1000 mL container, Rx Only, Manufactured by Hospira,… Lack of Assurance of Sterility: Potential of punctures through the overwrap and primary container which may result in… Hospira Inc. Terminated
Class II December 3, 2014 Phenylephrine HCl (100 mcg/mL syr) in 0.9% NaCl 1 mg / 10 mL, 3Ml Syringes, Compounded… Lack of sterility assurance;All lots of sterile products compounded by the pharmacy that are within expiry were… Perry Drug Inc. Terminated
Class II December 3, 2014 Normosol-R pH 7.4 Multiple Electrolytes Injection Type 1, USP, 1000 mL container, Rx… Lack of Assurance of Sterility: Potential of punctures through the overwrap and primary container which may result in… Hospira Inc. Terminated
Class II December 3, 2014 HCG-20,000 U/2 mL Vial, Compounded Rx, Perry Drug Compounding Pharmacy, Overland Park, KS… Lack of sterility assurance;All lots of sterile products compounded by the pharmacy that are within expiry were… Perry Drug Inc. Terminated
Class II December 3, 2014 Lactated Ringer's Injection, USP, 1000 mL container, Rx Only, Manufactured by Hospira,… Lack of Assurance of Sterility: Potential of punctures through the overwrap and primary container which may result in… Hospira Inc. Terminated
Class II December 3, 2014 HCG Low Dose 30 IU/0.1 mL, 5 Ml vial, Compounded Rx, Perry Drug Compounding Pharmacy,… Lack of sterility assurance;All lots of sterile products compounded by the pharmacy that are within expiry were… Perry Drug Inc. Terminated
Class II December 3, 2014 2Ml HCG 10,000 U/ MB12 - 12,000 MCG/10 Ml Inj, 0.25ML (250IU), Rx, Perry Drug Compounding… Lack of sterility assurance;All lots of sterile products compounded by the pharmacy that are within expiry were… Perry Drug Inc. Terminated
Class II December 3, 2014 0.45% Sodium Chloride Injection, USP, 1000 mL container, Rx Only, Manufactured by… Lack of Assurance of Sterility: Potential of punctures through the overwrap and primary container which may result in… Hospira Inc. Terminated
Class II December 3, 2014 HCG 200 IU/mL Injection, 30Ml, 10 mL vials, Compounded Rx, Perry Drug Compounding… Lack of sterility assurance;All lots of sterile products compounded by the pharmacy that are within expiry were… Perry Drug Inc. Terminated
Class II December 3, 2014 Tri-Mix (PGE-10MCG/PAP-30MG/PT 5Ml vials, Compounded Rx, Perry Drug Compounding Pharmacy,… Lack of sterility assurance;All lots of sterile products compounded by the pharmacy that are within expiry were… Perry Drug Inc. Terminated
Class II December 3, 2014 Methyl B12 25 mg/mL Inj., 10 Syringes, Compounded Rx, Perry Drug Compounding Pharmacy,… Lack of sterility assurance;All lots of sterile products compounded by the pharmacy that are within expiry were… Perry Drug Inc. Terminated
Class II December 3, 2014 Sterile Water for Injection, USP, 1000 mL container, Rx Only, Manufactured by Hospira,… Lack of Assurance of Sterility: Potential of punctures through the overwrap and primary container which may result in… Hospira Inc. Terminated
Class II December 3, 2014 Lactated Ringer's and 5% Dextrose Injection, USP; 1000 mL container, Rx Only,… Lack of Assurance of Sterility: Potential of punctures through the overwrap and primary container which may result in… Hospira Inc. Terminated
Class II December 3, 2014 Tri Mix PF SYR 0.5 mL Inj., Compounded Rx, 10 each, Compounded Rx, Perry Drug Compounding… Lack of sterility assurance;All lots of sterile products compounded by the pharmacy that are within expiry were… Perry Drug Inc. Terminated
Class II December 3, 2014 Tri-mix Antidote 10 each Syringes, Compounded Rx, Perry Drug Compounding Pharmacy,… Lack of sterility assurance;All lots of sterile products compounded by the pharmacy that are within expiry were… Perry Drug Inc. Terminated
Class II December 3, 2014 Testosterone CYP-250/PROP-20 mg, 10 Ml Syringe, Compounded Rx, Perry Drug Compounding… Lack of sterility assurance;All lots of sterile products compounded by the pharmacy that are within expiry were… Perry Drug Inc. Terminated
Class III December 3, 2014 Amlodipine Besylate Amlodipine Besylate Tablets, USP 10 mg, Rx Only, 90 Tablets per bottle, Manufactured by:… Discoloration: Brown spots were noted embedded in Amlodipine Besylate Tablets, 10 mg, Lot # MP4344. Zydus Pharmaceuticals USA Inc Terminated
Class II December 3, 2014 POTASSIUM CHLORIDE Potassium Chloride Injection, 10mEq per 100mL, 100 mL Sterile single dose container bags,… Labeling: Label Error On Declared Strength: Bags of Potassium Chloride 10 mEq per 100 mL were incorrectly overpouched… Baxter Healthcare Corp. Terminated
Class II December 3, 2014 HEPARIN SODIUM IN SODIUM CHLORIDE Heparin Sodium in 0.9% Sodium Chloride Injection, 1000 USP Heparin Units, 500 mL in a… Subpotent Drug: Heparin raw material was found to have low potency Baxter Healthcare Corp. Terminated
Class II December 3, 2014 Diclofenac Sodium and Misoprostol Diclofenac Sodium and Misoprostol Delayed-Release Tablets, 75 mg/0.2 mg, 60-count bottle,… Failed Tablet/Capsule Specifications: Presence of split or broken tablets. Actavis Laboratories, FL, Inc. Terminated
Class II November 26, 2014 Tetrahydrozoline Hydrochloride, USP, 1 KG Bottle. Spectrum Chemical MFG CORP., Gardena,… CGMP Deviations; Stored/dispensed in a non-GMP compliant warehouse at S.I.M.S., Italy. Spectrum Laboratory Products Terminated
Class I November 26, 2014 Lidocaine 18.18 mg/mL/Bupivacaine 2.27 mg/mL/Epinephrine 0.0022 mg/mL/Hyaluronidase13.64… Non-Sterility Abrams Royal Pharmacy Terminated
Class II November 26, 2014 Mercaptopurine Tablets, USP 50mg, a) 60-count bottle (NDC 49884-922-02), b) 250-count… Failed Dissolution Specifications: Product found to be out of specification (OOS) during stability testing. Prometheus Laboratories Inc. Terminated
Class I November 26, 2014 Trace Mineral-5 MDV, supplied in 10 mL vials, Each ML contains: 1 mg Zinc (as sulfate),… Non-Sterility; contract laboratory identified Staphylococcus warneri in the product Abrams Royal Pharmacy Terminated
Class I November 26, 2014 Calcium Chloride Preservative Free Sterile injection, 100 mg/ml, 10 ml vial, Rx only,… Non-Sterility: The firm's contract testing laboratory found sterility failures. Abrams Royal Pharmacy Terminated
Class III November 26, 2014 Vancomycin Hydrochloride Sterile powder Vancomycin Hydrochloride for Injection, USP, Equivalent to 1 g in 25 ml… Correct Labeled Product Mispack: Product tray containing vials was mislabeled to contain another product. Hospira Inc. Terminated
Class II November 26, 2014 LOSARTAN POTASSIUM TABLETS USP, 25 mg, 1000 Tablet Bottles, Rx Only. Manufactured by:… Failed Content Uniformity Specifications; Dry mix failed blend uniformity. Micro Labs Usa, Inc S Terminated
Class II November 19, 2014 Assured Naproxen Sodium Tablets, USP 220 mg., 15 count bottle, Repackaged by Contract… Correct Labeled Product Mispacked; correct labeled bottles of Assured Ibuprofen softgels were packaged into cartons of… Contract Packaging Resources Inc. Terminated
Class III November 19, 2014 Haloperidol Decanoate HALOPERIDOL DECANOATE INJECTION, 50 mg/mL, 1 mL vial, Rx only, Fresenius Kabi USA, LLC,… Failed Impurities/Degradation Specifications: Fresenius Kabi is recalling three lots of Haloperidol Decanoate Injection… Fresenius Kabi USA LLC Terminated
Class II November 19, 2014 FLUOCINONIDE GEL USP, 0.05%, Rx only, For External Use Only, Not For Ophthalmic Use, a)… Failed Stability Specifications: The lots of Fluocinonide Gel USP, 0.05% recalled, may not meet the requirements for… Fougera Pharmaceuticals Inc. Terminated
Class III November 19, 2014 Simvastatin Tablets, USP, 10 mg, Rx Only, 90 count bottles, Manufactured by: Micro Labs… Failed Impurities/Degradation Specifications: Product failed Impurity content (Butylated Hydroxy Anisole Content)… Micro Labs Usa, Inc S Terminated
Class III November 12, 2014 TORISEL Kit (temsirolimus) injection, 25 mg/mL, 1 vial of TORISEL 25 mg/mL and 1 vial of… Crystallization: Impurities in a raw material used to manufacture the diluent can cause the formation of crystals in… Pfizer Inc. Terminated
Class II November 12, 2014 PAPAVERINE HCL/PHENTOLAMINE MES/PROSTAGLANDIN, 23mg/0. 96mg/19.23mcg, injectable, 1.7 mL… Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to… Oregon Compounding Centers, Inc. dba Creative Compounds Terminated
Class III November 12, 2014 Z-COTE HP 1 TRANSPARENT ZINC OXIDE, Zinc Oxide (and) Triethoxycaprylylsilane, Powder,… cGMP Deviation; The incorrect amount of a raw material was added during the manufacture of two lots of Z-COTE HP 1. Nanophase Technologies Corporation Terminated
Class II November 12, 2014 HYDROXOCOBALAMIN-preservative free (B12), 1mg/mL, injectable, 2 mL glass vial, RX,… Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to… Oregon Compounding Centers, Inc. dba Creative Compounds Terminated
Class II November 12, 2014 PYRIDOXINE HCL, with preservative, 100 mg/mL, injectable, 30 mL glass vial, RX, Creative… Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to… Oregon Compounding Centers, Inc. dba Creative Compounds Terminated
Class II November 12, 2014 METHYCOBALAMIN, preservative free, 20mg/mL, injectable, 0.3 mL or 1 mL glass vial, RX,… Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to… Oregon Compounding Centers, Inc. dba Creative Compounds Terminated
Class III November 12, 2014 Loratadine 24 HR-OTC,10 mg, 30-count bottle, Manufactured by Novartis Consumer Health,… Failed Tablet/Capsule Specifications: Affected lot numbers may contain chipped or broken tablets. Physicians Total Care, Inc. Terminated
Class II November 12, 2014 ASCORBIC ACID (B), 500 mg/mL, injectable, 100 mL glass vial, RX, Creative Compounds,… Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to… Oregon Compounding Centers, Inc. dba Creative Compounds Terminated
Class II November 12, 2014 GANCICLOVIR, preservative free, 0.2mg/0.05mL, injectable, 0.1 mL plastic syringe, RX,… Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to… Oregon Compounding Centers, Inc. dba Creative Compounds Terminated
Class II November 12, 2014 GENTAMICIN SULFATE, 480mg/1000mL, solution for irrigation, 300 mL plastic bottle, RX,… Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to… Oregon Compounding Centers, Inc. dba Creative Compounds Terminated
Class II November 12, 2014 ASCORBIC ACID (with Preservative), 500 mg/mL, injectable, 100 mL glass vial, RX, Creative… Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to… Oregon Compounding Centers, Inc. dba Creative Compounds Terminated
Class III November 12, 2014 Candesartan Cilexetil Tablets, 8 mg, 30-count bottle, Rx Only, Manufactured by Apotex… Failed Impurities/Degradation Specifications: Out of specification (OOS) results were observed for CAD-II, CAD-V and… Apotex Inc. Terminated
Class II November 12, 2014 TESTOSTERONE CYPIONATE (GRAPE SEED OIL/COMPOUNDED), 200mg/mL, injectable, 5 mL glass… Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to… Oregon Compounding Centers, Inc. dba Creative Compounds Terminated
Class II November 12, 2014 CEPHALEXIN MONOHYDRATE CAPSULES,USP, 500 mg, 20-count bottle, Rx only, Manufactured for… CGMP deviations: Products were manufactured with active pharmaceutical ingredients that were not manufactured with good… Physicians Total Care, Inc. Terminated
Class II November 12, 2014 PAPAVERINE/PHENTOLAMINE/PROSTAGLANDIN, 17.16mg/0.57mg/19.45mcg, injectable, 1.7 mL glass… Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to… Oregon Compounding Centers, Inc. dba Creative Compounds Terminated
Class II November 12, 2014 DMPS-preservative free, 50 mg/mL, injectable, 5 mL glass vial, RX, Creative Compounds,… Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to… Oregon Compounding Centers, Inc. dba Creative Compounds Terminated
Class II November 12, 2014 PAPAVERINE HCL/PHENTOLAMINE MES/ALPROSTADIL, 22mg/0.8mg/8mcg, injectable, 1.25 mL glass… Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to… Oregon Compounding Centers, Inc. dba Creative Compounds Terminated
Class II November 12, 2014 ALPROSTADIL, 10 mcg/mL, injectable, 1.7 mL glass vial, RX, Creative Compounds,… Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to… Oregon Compounding Centers, Inc. dba Creative Compounds Terminated
Class II November 12, 2014 Cyproheptadine HCl Syrup (Cyproheptadine HCl Oral Solution, USP) 4mg/10 mL, Rx ONLY,… Failed Impurities/Degradation Specifications : Out-of-specification result for an unidentified impurity at the 12 month… Pharmaceutical Associates Inc Terminated
Class II November 12, 2014 OMNIPAQUE, 300mgI/mL, injectable, 2 mL glass vial, RX, Creative Compounds, Wilsonville,… Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to… Oregon Compounding Centers, Inc. dba Creative Compounds Terminated
Class II November 12, 2014 PREDNISOLONE Sodium Phosphate, 1%, Ophthalmic, 1 mL plastic dropper bottle, RX, Creative… Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to… Oregon Compounding Centers, Inc. dba Creative Compounds Terminated
Class II November 12, 2014 MITOMYCIN, 0.2mg/mL, injectable, 1 mL glass vial, RX, Creative Compounds, Wilsonville, OR… Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to… Oregon Compounding Centers, Inc. dba Creative Compounds Terminated
Class II November 12, 2014 LIDOCAINE HCL (REPKG-STERILE), 4%, solution for irrigation, 5 mL, 6 mL, and 7 mL plastic… Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to… Oregon Compounding Centers, Inc. dba Creative Compounds Terminated
Class II November 12, 2014 HYALURONIDASE, 240 u/mL, injectable, 1 mL glass vial, RX, Creative Compounds,… Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to… Oregon Compounding Centers, Inc. dba Creative Compounds Terminated
Class II November 12, 2014 VANCOMYCIN, 1mg/0.1mL, injectable, 0.2 mL plastic syringe, RX, Creative Compounds,… Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to… Oregon Compounding Centers, Inc. dba Creative Compounds Terminated
Class II November 12, 2014 CHORIONIC GONADOTROPIN, 5000 Units, sterile powder for reconstitution, glass vial, RX,… Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to… Oregon Compounding Centers, Inc. dba Creative Compounds Terminated
Class II November 12, 2014 GENTAMICIN SULFATE, 100mg/1000mL, solution for irrigation, 400 mL plastic bottle, RX,… Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to… Oregon Compounding Centers, Inc. dba Creative Compounds Terminated
Class II November 12, 2014 PAPAVERINE HCL/PHENTOLAMINE/ALPROSTADIL, 21.82mg/0.91mg/45mcg, injectable, 1.7 mL glass… Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to… Oregon Compounding Centers, Inc. dba Creative Compounds Terminated
Class II November 12, 2014 SODIUM CHLORIDE INHALATION, 7%, Solution for inhalation, 3 mL plastic vial, RX, Creative… Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to… Oregon Compounding Centers, Inc. dba Creative Compounds Terminated
Class II November 12, 2014 PAPAVERINE HCL/PHENTOLAMINE/PROSTAGLANDIN, 27.7mg/0.45mg/45.45mcg, injectable, 1.25 mL… Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to… Oregon Compounding Centers, Inc. dba Creative Compounds Terminated
Class II November 12, 2014 GLUTARALDEHYDE BUFFERED (POTASSIUM PHOSPHATE), solution for irrigation, 250 mL glass… Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to… Oregon Compounding Centers, Inc. dba Creative Compounds Terminated
Class II November 12, 2014 ESTRADIOL CYPIONATE (COMPOUNDED/GRAPESEED OIL), 5 mg/mL, injectable, 1 ml glass vial, RX,… Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to… Oregon Compounding Centers, Inc. dba Creative Compounds Terminated
Class II November 12, 2014 DEXPANTHENOL with preservative, 250 mg/mL, injectable, 30 mL glass vial, RX, Creative… Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to… Oregon Compounding Centers, Inc. dba Creative Compounds Terminated
Class II November 12, 2014 GLUTATHIONE with preservative, 100mg/mL, injectable, 100 mL glass vial, RX, Creative… Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to… Oregon Compounding Centers, Inc. dba Creative Compounds Terminated
Class II November 12, 2014 TOBRAMYCIN, 480mg/1000 mL, solution for irrigation, 500 mL plastic bottle, RX, Creative… Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to… Oregon Compounding Centers, Inc. dba Creative Compounds Terminated
Class II November 12, 2014 VITAMIN B COMPLEX (PRES) injectable, 100mg, 10 mL glass vial, RX, Creative Compounds,… Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to… Oregon Compounding Centers, Inc. dba Creative Compounds Terminated
Class II November 12, 2014 CHORIONIC GONADOTROPIN, 4000 Units, sterile powder for reconstitution, glass vial, RX,… Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to… Oregon Compounding Centers, Inc. dba Creative Compounds Terminated
Class II November 12, 2014 METHYCOBALAMIN, preservative free, 1mg/mL, injectable, 2 mL glass vial, RX, Creative… Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to… Oregon Compounding Centers, Inc. dba Creative Compounds Terminated
Class II November 12, 2014 COPPER (SULF), 0.4 mg/mL, injectable, 20 mL glass vial, RX, Creative Compounds,… Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to… Oregon Compounding Centers, Inc. dba Creative Compounds Terminated
Class II November 12, 2014 CALCIUM CHLORIDE (COMPOUND), 100 mg/mL, Injectable, 10 mL glass vial, RX, Creative… Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to… Oregon Compounding Centers, Inc. dba Creative Compounds Terminated
Class II November 12, 2014 CEFTAZIDIME, 2.25mg/0.1mL, Injectable, 0.2 mL plastic syringe, RX, Creative Compounds,… Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to… Oregon Compounding Centers, Inc. dba Creative Compounds Terminated
Class II November 12, 2014 PAPAVERINE HCL, with preservative, 30 mg/mL, injectable, 1.25 mL glass vial, RX, Creative… Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to… Oregon Compounding Centers, Inc. dba Creative Compounds Terminated
Class II November 12, 2014 BEVACIZUMAB/DEXAMETHASONE, 1.25/0.5 mL, Injectable, 0.05 mL plastic syringe, RX, Creative… Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to… Oregon Compounding Centers, Inc. dba Creative Compounds Terminated
Class III November 12, 2014 Candesartan Cilexetil Tablets, 16 mg, a) 30-count bottle (NDC 60505-3620-3) b) 90-count… Failed Impurities/Degradation Specifications: Out of specification (OOS) results were observed for CAD-II, CAD-V and… Apotex Inc. Terminated
Class II November 12, 2014 HYDROXOCOBALAMIN- preservative (B12), 1mg/mL, injectable, 10 mL glass vial, RX, Creative… Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to… Oregon Compounding Centers, Inc. dba Creative Compounds Terminated
Class II November 12, 2014 TESTOSTERONE CYPIONATE (SESAME OIL/CMPD), 200mg/mL, injectable, 5 mL glass vial, RX,… Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to… Oregon Compounding Centers, Inc. dba Creative Compounds Terminated
Class II November 12, 2014 TRIESENCE, 8mg/2.0mL, Injectable, 0.2 mL plastic syringe, RX, Creative Compounds,… Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to… Oregon Compounding Centers, Inc. dba Creative Compounds Terminated
Class II November 12, 2014 AVASTIN, 1.25mg/0.5mL, injectable, 0.05 mL plastic syringe, RX, Creative Compounds,… Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to… Oregon Compounding Centers, Inc. dba Creative Compounds Terminated
Class II November 12, 2014 EPINEPHRINE/WATER, preservative free 1:1000, injectable, 1 mL glass vial, RX, Creative… Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to… Oregon Compounding Centers, Inc. dba Creative Compounds Terminated
Class III November 12, 2014 Candesartan Cilexetil Tablets, 4 mg, 30-count bottle, Rx Only, Manufactured by Apotex… Failed Impurities/Degradation Specifications: Out of specification (OOS) results were observed for CAD-II, CAD-V and… Apotex Inc. Terminated
Class II November 12, 2014 GANCICLOVIR -preservative free, 2mg/0.1mL, injectable, 0.1 mL plastic syringe, RX,… Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to… Oregon Compounding Centers, Inc. dba Creative Compounds Terminated
Class II November 12, 2014 DEXAMETHASONE (AS SOD PHOS), 24 mg/mL, injectable, 1 mL glass vial, RX, Creative… Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to… Oregon Compounding Centers, Inc. dba Creative Compounds Terminated
Class II November 12, 2014 PAPAV HCL/PHENTOL/PROSTAGL, 12mg/1mg/10mcg, injectable, 1.25 mL glass vial or 1.7 ml… Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to… Oregon Compounding Centers, Inc. dba Creative Compounds Terminated
Class II November 12, 2014 PAPAVERINE/PHENTOLAMINE/PROSTAGLANDIN, 17.64mg/0.58mg/5.8mcg, injectable, 1.7 mL glass… Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to… Oregon Compounding Centers, Inc. dba Creative Compounds Terminated
Class II November 12, 2014 CITRIC ACID/GLUCONOLACTONE MAGNES CARB (RENACIDIN), 66/1.98/31.77 mg/mL, solution for… Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to… Oregon Compounding Centers, Inc. dba Creative Compounds Terminated
Class II November 12, 2014 GLUTATHIONE, 100 mg/mL, injectable, 100 mL glass vial, RX, Creative Compounds,… Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to… Oregon Compounding Centers, Inc. dba Creative Compounds Terminated
Class III November 12, 2014 Candesartan Cilexetil Tablets, 32 mg, a) 30-count bottle (NDC 60505-3621-3) b) 90-count… Failed Impurities/Degradation Specifications: Out of specification (OOS) results were observed for CAD-II, CAD-V and… Apotex Inc. Terminated
Class II November 12, 2014 HYDROXYPROGESTERONE CAPROATE (SESAME OIL), 250mg/mL, injectable, 5 mL glass vial, RX,… Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to… Oregon Compounding Centers, Inc. dba Creative Compounds Terminated
Class II November 12, 2014 PROCAINE HCL (BUFF), 1%, injectable, 10 mL glass vial, RX, Creative Compounds,… Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to… Oregon Compounding Centers, Inc. dba Creative Compounds Terminated
Class II November 12, 2014 METHYCOBALAMIN, preservative free, 10mg/mL, injectable, 1 mL glass vial, RX, Creative… Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to… Oregon Compounding Centers, Inc. dba Creative Compounds Terminated
Class II November 12, 2014 Venlafaxine Hydrochloride Extended-Release Tablets, 37.5 mg, 30-count bottles and… Failed Dissolution Specifications; 12 month stability time point Sun Pharma Global Inc. Terminated
Class II November 12, 2014 PAPAVERINE/PHENTOLAMINE/PROSTAGLANDIN, 17.44mg/0.64mg/5.8mcg, injectable, 1.7 mL glass… Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to… Oregon Compounding Centers, Inc. dba Creative Compounds Terminated
Class II November 12, 2014 MITOMYCIN, 0.3mg/mL, injectable, 1 mL glass vial, RX, Creative Compounds, Wilsonville, OR… Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to… Oregon Compounding Centers, Inc. dba Creative Compounds Terminated
Class II November 12, 2014 PAPAVERINE/PHENTOLAMINE/ALPROSTADIL, 26.5mg/0.98mg/58.9mcg, injectable, 1.25 mL glass… Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to… Oregon Compounding Centers, Inc. dba Creative Compounds Terminated
Class II November 12, 2014 ALPROSTADIL/LIDOCAINE HCL, 20mcg/5mg/mL, 1.25 mL glass vial, RX, Creative Compounds,… Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to… Oregon Compounding Centers, Inc. dba Creative Compounds Terminated
Class II November 12, 2014 METHYCOBALAMIN, preservative, 1mg/mL, injectable, 10 mL glass vial, RX, Creative… Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to… Oregon Compounding Centers, Inc. dba Creative Compounds Terminated