Drug and pharmaceutical recalls
17747 federal recalls on file. Federal recalls for prescription drugs, OTC medications, supplements, and pharmaceuticals. Sourced from the FDA and translated into plain English.
- 2015-04-01FDA-DrugMylan Institutional LLCClass IIHaloperidol Decanoate Injection, 100 mg/mL, For Intra Muscular Use Only, 1 mL single dose vials (NDC 67457-409-00) packaged in cartons of five (NDC 67457-409-13), Rx only, Manufactured in India for: Mylan Institutional LLC Rockford, IL 61103
Lack of Assurance of Sterility; due to leaking vials
- 2015-04-01FDA-DrugWest-Ward Pharmaceutical CorporationClass IIIFentanyl Citrate Inj., USP, CII, 250 mcg/5 mL (50 mcg/mL) (0.05 mg/mL) 25 x 5 mL Single Dose Vials, For Intravenous or Intramuscular Use, Preservative Free, Rx Only, Manufactured by: West-Ward Pharmaceuticals, Eatontown, NJ 07724, NDC 0641-6028-25.
Failed Impurities/Degradation Specifications; 12 month stability testing.
- 2015-03-25FDA-DrugTarmac Products, Inc.Class IIAntacid Liquid Regular Strength Antacid & Anti-Gas (Aluminum hydroxide 200 mg, Magnesium hydroxide 200 mg, Simethicone 20 mg (in each 5 mL, 1 teaspoon), Mint flavor, 12 fl oz (355 mL) bottle, Distributed By: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015, NDC 0363-0073-02, UPC 3 11917 15114 4.
Microbial Contamination of Non-Sterile Products: Lots failed microbiological testing at the 12-month time point.
- 2015-03-25FDA-DrugHospira Inc.Class II5% DEXTROSE Injection, USP, 250 mL ADD-Vantage Unit bag (NDC 0409-7100-02), UPC (01)0030404097100026; packaged in 24 bags per case pack (NDC 0409-7100-02), UPC (01)30304097100027(30)01, Rx ONLY, Hospira, Inc., Lake Forest, IL 60045.
Lack of Assurance of Sterility: there is a potential for solution to leak at the administrative port of the primary container.
- 2015-03-25FDA-DrugHeritage Pharmaceuticals, Inc.Class IIRIFAMPIN for Injection,USP, 600 mg per vial, Rx Only, Manufactured by: Emcure Pharmaceuticals Ltd., Hinjwadi, Pune, India Manufactured for: Heritage Pharmaceuticals Inc., Eatontown, NJ 07724 NDC 23155-340-31
Lack of Assurance of Sterility: Firm is recalling two injectable products due to concerns with quality control processes.
- 2015-03-25FDA-DrugHeritage Pharmaceuticals, Inc.Class IIColistimethate for Injection USP, 150 mg per vial, Rx Only, Manufactured by: Emcure Pharmaceuticals Ltd., Hinjwadi, Pune, India Manufactured for: Heritage Pharmaceuticals Inc. NDC 23155-193-31
Lack of Assurance of Sterility: Firm is recalling two injectable products due to concerns with quality control processes.
- 2015-03-25FDA-DrugMutual Pharmaceutical Company, Inc.Class IIErgoloid Mesylates ,1 mg tablets, 100 count bottle, Rx only, Manufactured by MUTUAL PHARMACEUTICAL CO., INC., PHILADELPHIA, PA 19124 USA for Sun Pharmaceutical Industries, Inc. 270 Prospect Plains Road, Cranbury, NJ 08512. NDC 53489-281-01
Failed Impurities/Degradation Specifications: during long-term stability testing.
- 2015-03-25FDA-DrugMylan Institutional LLCClass IIINicardipine Hydrochloride Injection, 25 mg/10 ml (2.5 mg/mL),10 mL single dose vial, Rx only, Manufactured in India for: Mylan Institutional LLC, Rockford, IL 61103, NDC 67457-224-10
Subpotent Drug and Failed Impurities/Degradation Specifications
- 2015-03-25FDA-DrugMylan Institutional LLCClass IIIDOXOrubicin Hydrochloride Injection, USP, 200 mg/100 mL (2 mg/mL), For IV Use Only, Sterile, ISOTONIC SOLUTION, Caution: Cytotoxic Agent, 100 mL Multi-Dose Vial, Rx Only, Manufactured By: Onco Therapies Limited, Bangalore, 560105, INDIA, Distributed By: Amneal-Agila, LLC, Glasgow, KY, 42141, NDC 53150-317-01.
Correct Labeled Product Mispack: Ifosfamide Injection 50 mg/mL, 60 mL, correctly labeled vial may have been mis-packaged in a carton labeled Doxorubicin Hydrochloride Injection 2 mg/mL, 100 mL
- 2015-03-18FDA-DrugQualitest PharmaceuticalsClass IIPROMETHAZINE DM SYRUP (Promethazine Hydrochloride, USP and Dextromethorphan Hydrobromide, USP), EACH 5 ml (ONE TEASPOONFUL) CONTAINS: Promethazine Hydrochloride 6.25 mg, Dextromethorphan Hydrobromide 15 mg, alcohol 7%, ONE PINT (574 mL), Rx only, Manufactured for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811, NDC: 0603-1586-58.
Presence of Foriegn Substance: Plastic cap closure particulates may be present in the product.
- 2015-03-18FDA-DrugFusion Pharmaceuticals, LLCClass IIDICOPANOL (diphenhydramine hydrochloride in 5 mg/mL oral suspension kit) FusePaq, 150 mL Kits, Rx Only. Fusion Pharmaceuticals LLC., 768 Calle Plano, Camarillo, CA 93012. NDC: 43093-104-01.
Microbial Contamination of a Non-Sterile Product: Kit component is contaminated with Burkholderia multivorans.
- 2015-03-18FDA-DrugMicro Labs Usa, Inc SClass IIISimvastatin Tablets, USP, 80mg, Rx Only, 90 count bottles, Manufactured by: Micro Labs Limited Goa-403 722, India, Manufactured for: Micro Labs USA Inc., Princeton, NJ 08540 NDC 42571-080-90.
Failed Impurities/Degradation Specifications: Product failed a known impurity specification.
- 2015-03-18FDA-DrugMicro Labs Usa, Inc SClass IIISimvastatin Tablets, USP, 40mg, Rx Only, 90 count bottles, Manufactured by: Micro Labs Limited Goa-403 722, India, Manufactured for: Micro Labs USA Inc., Princeton, NJ 08540 NDC 42571-0040-90.
Failed Impurities/Degradation Specifications: Product failed a known impurity specification.
- 2015-03-18FDA-DrugMicro Labs Usa, Inc SClass IIISimvastatin Tablets, USP, 20mg a) 90- count bottle (42517-0020-10), b) 1000-count-bottle (NDC 42571-0020-10), Rx only, Manufactured by: Micro Labs Limited Goa-403 722, India, Manufactured for: Micro Labs USA Inc.,Princeton, NJ 08540
Failed Impurities/Degradation Specifications: Product failed a known impurity specification.
- 2015-03-11FDA-DrugActavis IncClass IIVancomycin Hydrochloride Capsules, USP, 250 mg, 2 x 10 count blister pack, Rx Only, Manufactured for Watson Pharma Inc., Parsippany, NJ 07054, by Patheon Pharmaceuticals Inc., Cincinnati, OH. NDC 0591-3561-15
Subpotent Drug
- 2015-03-11FDA-DrugAkorn, Inc.Class IIFluticasone Propionate Nasal Spray, USP, 50 mcg per spray, in amber glass bottle with net fill weight of 16 g that provides 120 actuations, Rx only, Manufactured by HI-TECH PHARMACAL CO., INC. Amityville, NY 11701 for Akorn Inc. 1925 W. Field Court, Suite 300 Lake Forest Illinois, 60045. NDC 50383-700-16.
Failed Stability Specifications: Out of specification for preservative, benazalkonium chloride.
- 2015-03-11FDA-DrugPfizer Inc.Class IIIOxecta(TM) (oxycodone HCl) tablets, 7.5 mg, 100 count bottles, Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc. Bristol, TN, NDC 60793-526-01
Failed Impurities/Degradation Specifications
- 2015-03-11FDA-DrugPfizer Inc.Class IIIOxecta(TM) (oxycodone HCl) tablets, 5 mg, 100 count bottles, Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc. Bristol, TN, NDC 60793-525-01
Failed Impurities/Degradation Specifications
- 2015-03-11FDA-DrugAVKARE Inc.Class IIIQuinapril Tablets USP, 40 mg, Rx only, 50 tablets (5 X 10) unit dose pack, Manufactured for: AvKARE, Inc., Pulaski, TN 38478, UPC 5026869115, NDC 50268-691-15
Subpotent Drug
- 2015-03-11FDA-DrugAVKARE Inc.Class IIIQuinapril Tablets USP, 5 mg, Rx only, 50 tablets (5 X 10) unit dose pack, Manufactured for: AvKARE, Inc., Pulaski, TN 38478, UPC 5026868815, NDC 50268-688-15
Subpotent Drug
- 2015-03-11FDA-DrugNanophase Technologies CorporationClass IIIZ-COTE HP 1 TRANSPARENT ZINC OXIDE, Zinc Oxide (and) Triethoxycaprylylsilane, powder, Net: 22 kg, Packaged in double plastic liners in a single fiber carton, For manufacturing, processing, or repackaging. Nano Technologies Corporation 1319 Marquettte Drive, Romeoville, IL 60446. NDC 10117-3004
Labeling: Illegible label. Writing is rubbing off of labels.
- 2015-03-11FDA-DrugSagent Pharmaceuticals IncClass IIAtracurium Besylate Injection, USP, 100 mg per 10 mL (10 mg per mL), Rx Only, 10 mL Multi-Dose Vial, For Intravenous Injection, Mfd. for: Sagent Pharmaceuticals, Schaumberg, IL 60195, NDC 25021-672-10
Lack of Assurance of Sterility: Recall initiated due to FDA observations pertaining to aseptic and GMP practices at the manufacturers site potentially impacting product sterility.
- 2015-03-11FDA-DrugSagent Pharmaceuticals IncClass IIAtracurium Besylate Injection, USP, 50 mg per 5 mL (10 mg per mL), Rx Only, 5 mL Single-Dose Vial, For Intravenous Injection, Mfd. for: Sagent Pharmaceuticals, Schaumberg, IL 60195, NDC 25021-659-05
Lack of Assurance of Sterility: Recall initiated due to FDA observations pertaining to aseptic and GMP practices at the manufacturers site potentially impacting product sterility.
- 2015-03-11FDA-DrugQualitest PharmaceuticalsClass IIAMLODIPINE BESYLATE TABLETS USP, 10 mg*, 1000 count bottles (NDC 0603-2110-32), Rx only, Manufactured for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811
Failed tablet specifications: One lot was found to contain oversized tablets.
- 2015-03-11FDA-DrugActavis IncClass IIVancomycin Hydrochloride Capsules, USP, 125 mg, 2 x 10 count blister pack, Rx Only, Manufactured for Watson Pharma Inc., Parsippany, NJ 07054, by Patheon Pharmaceuticals Inc., Cincinnati, OH. NDC 0591-3560-15
Subpotent Drug
- 2015-03-11FDA-DrugActavis Elizabeth LLCClass IIDextroamphetamine Sulfate Extended-Release Capsules, 15 mg, 90-count bottles, Rx Only, Manufactured by: Actavis Elizabeth LLC, Elizabeth, NJ 07201 USA; Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054 USA; NDC 45963-305-09, UPC 3 45963-305-09 1.
Failed Dissolution Specifications
- 2015-03-04FDA-DrugSun Pharma Global FzeClass IIKetorolac Tromethamine Ophthalmic Solution, 0.5%, 3 mL bottle, Rx only, Distributed by: Caraco Pharmaceutical Laboratories Ltd., 1150 Elijah Mccoy Drive, Detroit, MI 48202; Manufactured at: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India; NDC 41616-219-90, UPC 3 41616 21990 6.
Presence of Particulate Matter: lot is not meeting the specification limit for number of particles present in the solution.
- 2015-03-04FDA-DrugPar Pharmaceutical Inc.Class IIMafenide Acetate, USP, For 5% Topical Solution, STERILE, Net Wt. 50 grams sterile powder per packet, Rx only, PAR Pharmaceuticals label --- Distributed by: Par Pharmaceutical Companies, Inc. Spring Valley, NY 10977 Made in India -- NDC 49884-902-52 (packets of 50 g) and NDC 49884-902-78 (cartons of five 50 g packets)
Presence of Foreign Substance; oxidized steel, organic material and shredded polypropylene
- 2015-02-25FDA-DrugHospira Inc.Class ILACTATED RINGER'S and 5% DEXTROSE Injection USP, 1000 mL, flexible containers, Rx Only, Hospira, Inc., Lake Forest, IL 600045, NDC 0409-7929-09
Non-Sterility: Confirmed customer complaint of particulate matter floating within the solution of the primary container, consistent with mold.
- 2015-02-25FDA-DrugHospira Inc.Class I1% LIDOCAINE HCl Injection, USP, 10 mg/mL, 30 mL Single-dose, Preservative-Free glass vial (Twenty-five (25) units per box/fifty (50) units per case, NDC 0409-4279-02, Hospira, Inc., Lake Forest, IL 60045
Presence of particulate matter: A returned customer sample was evaluated and found to have human hair attached to a pinched area of the stopper.
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