Drug and pharmaceutical recalls
17628 federal recalls on file. Federal recalls for prescription drugs, OTC medications, supplements, and pharmaceuticals. Sourced from the FDA and translated into plain English.
- 2016-07-13FDA-DrugLyne Laboratories, Inc.Class IIICyproheptadine Hydrochloride Syrup, Oral Solution USP, 2 mg/5 mL, packaged in an amber glass 473 mL (one pint) bottle with child-resistant screw closure, Rx only, Distributed by: Rising Pharmaceuticals, Inc., Allendale, NJ 07401, Manufactured by: Lyne Laboratories, Inc., Brockton, MA 02301, NDC 64980-0504-48
Subpotency: product assayed and found OOS for cyproheptadine
- 2016-07-06FDA-DrugAidarex Pharmaceuticals LLCClass IIICiprofloxacin OPTH 0.3% SOL, generic for: Ciloxan, Rx Only, 2.5 mL Bottle, Repackaged by: Aidarex Pharmaceuticals, MFG: Hi-Tech Pharmacal Co., Inc., Amityville, NY, 11701, NDC a) 33261-0910-01, b) 33261-0614-01
Failed Impurities/Degradation Specifications: Out of specification results for unknown impurity.
- 2016-07-06FDA-DrugActavis Pharma IncClass IIICiprofloxacin Ophthalmic Solution (0.3% as base), Sterile, Rx only, a) 2.5 mL Bottle, b) 5 mL Bottle, c) 10 mL Bottle, For Topical Ophthalmic Use Only, Hi-Tech Pharmacal Co. Inc., Amityville, NY 11701, NDC: a) 50383-0282-02, b) 50383-282-05, c) 50383-0282-10
Failed Impurities/Degradation Specifications: Firm voluntarily recalled products due to out-of-specification results for an unknown impurity at or near the expiration (24-month).
- 2016-07-06FDA-DrugValeant Pharmaceuticals North America LLCClass IIISECONAL SODIUM (secobarbital sodium) Capsules, USP, 100 mg, 100 Ct. Bottles, Rx Only. Distributed by: Valeant Pharmaceuticals North America, LLC, Bridgewater, NJ 08807. NDC: 0187-4220-10.
Labeling: Incorrect or Missing Package Insert: Package insert is missing warning regarding anaphylaxis.
- 2016-07-06FDA-DrugDr. Reddy's Laboratories, Inc.Class IIICVS pharmacy Original Strength Acid Controller tablets, 10 mg, 30-count bottle, OTC, Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895, UPC 150049523
Failed impurities/degradation specification: An out of specification results has been determined for an individual related substance during stability testing at the 18th month interval for the Famotidine 10 mg Tablet, USP.
- 2016-07-06FDA-DrugKVK-Tech, Inc.Class IIIBenzphetamine Hydrochloride Tablets, 50 mg, 30-count bottle, RX only, Mfd by: KVK-TECH, INC., Newtown, PA 18940, NDC 10702-0040-03
Discoloration: presence of scuffing marks on tablets.
- 2016-07-06FDA-DrugVital Care CompounderClass IITrypan Blue 0.3%, 0.5 mL Vial, Vital Care Compounder, Hattiesburg, MS
Lack of Assurance of Sterility: Aluminum crimps do not fully seal the rubber stopper to the vials.
- 2016-07-06FDA-DrugVital Care CompounderClass IIBrilliant Blue G BBG, 0.025%, Sterile Injection, 0.5 mL Single Dose Vial, Vital Care Compounder, Hattiesburg, MS
Lack of Assurance of Sterility: Aluminum crimps do not fully seal the rubber stopper to the vials.
- 2016-07-06FDA-DrugVital Care CompounderClass IIMethylcobalamin 5,000 mcg/ml, Sodium Chloride 0.9%,1 mL SDV, Vital Care Compounder, Hattiesburg, MS
Lack of Assurance of Sterility: Aluminum crimps do not fully seal the rubber stopper to the vials.
- 2016-07-06FDA-DrugThe Aloe SourceClass IIaloe SPORT liniment TOPICAL ANALGESIC 8 fl oz. tube, ALOE VERA Liniment Topical Analgesic 8 fl oz. bottle, Manufactured by Coats International, Inc., the ALOE SOURCE SPORT Sport Thermogenic Eucalyptus Cream 1 fl oz. plastic bottle, Dallas, TX 75243, NDC 58826-704-08, UPC 732295704089
CGMP Deviations
- 2016-07-06FDA-DrugLupin Pharmaceuticals Inc.Class IIILisinopril & Hydrochlorothiazide Tables, USP 20mg/12.5mg, packaged in a)100-count bottles and b) 5000-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, Manufactured by: Lupin Limited Pithampur (M.P.) 454 775 India, a) NDC 68180-519-01, b) 68180-519-30
CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.
- 2016-06-29FDA-DrugPrinston Pharmaceutical IncClass IIIIrbesartan and Hydrochlorothiazide Tablets, USP, 300/12.5 mg, Rx only, Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd, Xunqiao, Linhai, Zhejiang 317024, China; Distributed by: Solco Healthcare U.S., LLC, Cranbury, NJ 08512, NDC 43547-331-09.
Labeling: Incorrect or Missing Lot and/or Exp Date: Incorrect lot number, 327B160012, appears on the case label, the correct lot number, 327B16002 appears on the immediate container.
- 2016-06-29FDA-DrugVirtus Pharmaceuticals, LlcClass IIIVP-CH-PNV Prenatal/Postnatal capsules, prenatal supplement, 30-count bottle, Rx only, Manufactured for: Virtus Pharmaceuticals, LLC, Tampa, FL 33619, NDC 69543-224-30
Defective delivery system: Softgel capsules are leaking.
- 2016-06-29FDA-DrugAttix Pharmaceuticals IncClass IIIMycophenolate Mofetil, Bulk Powder, Quantity 1000 g, For prescription compounding use and medical manufacturing or processing only, Attix Pharmaceuticals, Toronto, Canada
cGMP deviation; manufacturer is Not Registered with the Food and Drug Administration
- 2016-06-29FDA-DrugSandoz, IncClass IIIDicloxacillin Sodium Capsules USP, 500mg, Rx Only, 100 Capsule bottle, Manufactured in Austria by Sandoz Gmbh, Distributed by Sandoz Inc. , Princeton, NJ 08540, Product of Spain, NDC 0781-2258-01
Failed Impurities/Degradation Specifications:Out of specification result for a known impurity obtained during testing.
- 2016-06-29FDA-DrugSandoz, IncClass IIIDicloxacillin Sodium Capsules, USP 250mg, Rx Only, 100 Capsule Bottle, Manufactured in Austria by Sandoz Gmbh, Distributed by Sandoz Inc., Princeton, NJ 08540, Product of Spain, NDC 0781-2248-01
Failed Impurities/Degradation Specifications:Out of specification result for a known impurity obtained during testing.
- 2016-06-29FDA-DrugVirtus Pharmaceuticals, LlcClass IIIHyoscyamine Sulfate Sublingual Tablets, 0.125 mg, packaged in 100-count bottles, Rx only, Manufactured for: Virtus Pharmaceuticals OPCO II, LLC. Nashville, TN 37217. NDC 76439-0309-10
Chemical Contamination: Bottles may contain broken dessicants
- 2016-06-29FDA-DrugProfarma Distributors LLCClass II1% Clotrimazol cream, 30 mg tube, UPC 501318644335
CGMP Deviations
- 2016-06-29FDA-DrugProfarma Distributors LLCClass IIVERMOX Tablets 500 mg, 1-count box, UPC 501109900596
CGMP Deviations
- 2016-06-29FDA-DrugProfarma Distributors LLCClass IIVERMOX Tablets 100 mg; 6-count box, UPC 7501109900619
CGMP Deviations
- 2016-06-29FDA-DrugProfarma Distributors LLCClass IItabcin NOCHE; Capsules,12-count box, UPC 501008485033
CGMP Deviations
- 2016-06-29FDA-DrugProfarma Distributors LLCClass IItabcin ACTIVE M.R. Capsules, 12-count box , UPC 7501008485057
CGMP Deviations
- 2016-06-22FDA-DrugPar PharmaceuticalClass IIIPramipexole Dihydrochloride Extended Release Tablets, 0.375 mg, Rx Only, 30 count bottles, Manufactured By: Par Pharmaceutical Companies, Inc., Chestnut Ridge, NY 10977, NDC 10370-251-11
Failed Impurities/Degradation Specifications: Par Pharmaceutical is recalling Pramipexole Dihydrochloride Extended Release tablets because it contains a known product impurity above currently approved specification levels.
- 2016-06-22FDA-DrugFresenius Kabi USA, LLCClass IISensorcaine- MPF (Bupivacaine HCI Injection, USP), 0.75% in a 30 mL Single Dose Vial, Rx only, Fresenius Kabi USA LLC, Lake Zurich, IL 60047, NDC 63323-472-37
Presence of Particulate Matter: Glass particulate found in sterile injectable product
- 2016-06-22FDA-DrugSandoz IncClass IIILisinopril Tablets USP, 30 mg, 100-count bottle, Rx Only, Manufactured by Sandoz Inc., Princeton, NJ 08540, NDC 0185-0630-01
Labeling: Incorrect or Missing Package Insert
- 2016-06-22FDA-DrugValeant Pharmaceuticals North America LLCClass IIIChlordiazepoxide HCl/Clidinium Bromide capsules, 5 /2.5 mg, 100-count bottle, Rx Only, Manufactured in Canada by: Valeant Pharmaceuticals International, Inc., Steinbach, MB R5G 1Z7 Canada; Manufactured for: Oceanside Pharmaceuticals, a division of Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807, NDC 68682-409-10.
Failed Impurities/Degradation Specifications
- 2016-06-22FDA-DrugValeant Pharmaceuticals North America LLCClass IIILibrax (5 mg chlordiazepoxide HCl and 2.5 mg clidinium bromide) capsules, 100-count bottle, Rx Only, Manufactured in Canada by: Valeant Pharmaceuticals International, Inc., Steinbach, MB R5G 1Z7 Canada; Manufactured for: Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807, NDC 0187-4100-10.
Failed Impurities/Degradation Specifications
- 2016-06-22FDA-DrugHospira Inc.Class IIVancomycin Hydrochloride for Injection, USP, 10 g, 100 mL vial, Rx only, Hospira, Lake Forest, IL, NDC 0409-6510-01
Presence of Particulate Matter: Cardboard
- 2016-06-22FDA-DrugValeant Pharmaceuticals North America LLCClass IIILodrane D (Brompheniramine maleate 4 mg and Pseudoephedrine HCl 60 mg) Capsules, 60-count bottles, Distributed by: Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807, UPC 0 00950 86006 8.
Labeling: Not Elsewhere Classified: correctly labeled bottles were packaged in cartons that were mislabeled with an incorrect active ingredient, phenylephrine rather than pseudoephedrine, on the carton face and carton top.
- 2016-06-22FDA-DrugGalderma Laboratories, L.P.Class IIIDoxycycline, USP Capsules 40 mg, Packaged in 30 ct Bottles, Rx Only. Marketed by: Prasco Laboratories, Mason, OH 45040 USA, Manufactured by: Catalent Pharma Solutions, LLC, Winchester, Kentucky 40391. NDC: 66993-815-30.
Labeling: Incorrect Or Missing Lot and/or Exp Date: Some expiries and lot numbers are missing.
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