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.
- 2015-02-25FDA-DrugHospira Inc.Class IIVancomycin Hydrochloride for Injection, USP, 1 g Sterile Powder per Fliptop Vial, packaged in 10 Units per carton, Rx only, Hospira Inc., Lake Forest, IL 60045, NDC 0409-6533-01.
Temperature Abuse: Products experienced uncontrolled temperature excursions during transit.
- 2015-02-25FDA-DrugHospira Inc.Class IPropofol Injectable Emulsion, 1%, 200 mg/20 mL (10 mg/mL), 20 mL Single patient infusion vials, packaged in 5 Units per carton, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-4699-30.
Temperature Abuse: Products experienced uncontrolled temperature excursions during transit.
- 2015-02-25FDA-DrugHospira Inc.Class IIKetorolac Tromethamine Inj., USP, 60 mg (30 mg/mL), 2 mL Single-dose Fliptop Vial, packaged in 25 Units per carton, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-3796-01.
Temperature Abuse: Products experienced uncontrolled temperature excursions during transit.
- 2015-02-25FDA-DrugHospira Inc.Class IIVancomycin Hydrochloride for Injection, USP, 500 mg Sterile Powder per Fliptop Vial, packaged in 10 Units per carton, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-4332-01.
Temperature Abuse: Products experienced uncontrolled temperature excursions during transit.
- 2015-02-18FDA-DrugAnazaoHealth CorporationClass IICompounded Plaquex, intravenous injection, 50 ML vial. Each ml contains: Phosphatidyl Choline 50 mg, Sodium Deoxycholate 25 mg, Benzyl Alcohol 0.9%, Ethanol (95%) 2.4 mg di Alpha Tocopheryl Acetate 0.2 mg in Sterile Water for injection.
Good Manufacturing Practices Deviations: The product has an active pharmaceutical ingredient from an unapproved source.
- 2015-02-18FDA-DrugSun Pharma Global FzeClass IILevetiracetam, extended release tablets, 750 mg, 60-count bottle, Rx only, Manufactured by Sun Pharmaceutical Ind. Ltd Halol-Baroda Highway, Halol-389 350, Gujarat, India, NDC Number: 47335-576-86
Failed Dissolution Specifications: 6 month time point.
- 2015-02-18FDA-DrugAkorn, Inc.Class IIErythromycin Pledgets USP, 2%, 60-count jar,Rx only, Manufactured by Ei LLC, Kannapolis, NC 28083, Marketed by VersaPharm Incorporated, Marietta, GA 30062, NDC 61748-202-60 .
Microbial Contamination of Non-Sterile Products: Active Pharmaceutical Ingredient (API) failed USP microbial tests.
- 2015-02-11FDA-DrugTaro Pharmaceuticals U.S.A., Inc.Class IIChildren's Loratadine Syrup (Loratadine Oral Solution) 5 mg/5 mL, Antihistamine, Grape Flavored Syrup, 24 Hour Non-Drowsy Allergy Relief Sugar Free, 4 FL OZ (120 mL) Bottles, Distributed by: Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532. NDC: 51672-2092-8.
Presence of Foreign Substance: Presence of blue plastic floating in loratadine syrup.
- 2015-02-11FDA-DrugHospira Inc.Class I1% LIDOCAINE HCl Injection, USP, Preservative-Free, 10 mg/mL, 30 mL Single-dose vials, packaged in 25-count cartons, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-4279-02.
Presence of Particulate Matter: Confirmed customer complaint that orange and black particulates, identified as iron oxide, were found embedded within the glass vial and floating in solution.
- 2015-02-04FDA-DrugHospira Inc.Class IIPropofol Injectable Emulsion, 1%, 200 mg/20 mL, (10mg/mL), 20 mL, Single patient infusion vial, Contains Benzyl Alcohol, For I.V. Administration, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-4699-30
Presence of Particulate Matter: The firm received a complaint of an embedded particulate in the neck of one vial composed primarily of iron.
- 2015-02-04FDA-DrugBaxter Healthcare Corp.Class IIFluconazole Injection, USP, 200 mg/100 mL (2 mg/mL), 100 mL Single-Dose INTRAVIA Container bag, packaged in 10 x 100 mL Single Dose INTRAVIA container bags per carton, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA, NDC 0338-6046-48, Product Code 2J1446.
Lack of Assurance of Sterility: Complaints of leaks due to an incomplete seal at the bag seam.
- 2015-01-28FDA-DrugValeant Pharmaceuticals North America LLCClass IIVirazole (Ribavirin for Inhalation Solution, USP), Sterile Lyophilized For Administration by Aerosol Inhalation Only, Rx only, Contents: Four 6 g vials, 100 mL, Distributed by: Valeant Pharmaceuticals North America, Bridgewater, NJ 08807 USA, NDC 0187-0007-14.
Non-Sterility: Valeant's laboratory observed a positive microbial contamination of Virazole lot 340353F, during testing at the 12 month stability pull.
- 2015-01-28FDA-DrugMylan Institutional, Inc. (d.b.a. UDL Laboratories)Class IILAMOTRIGINE TABLETS, 200 mg, 100 Tablets (10 tablets per blister card x 10 blister cards per carton), Rx only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV --- NDC 51079-866-20
CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices
- 2015-01-28FDA-DrugMylan Institutional, Inc. (d.b.a. UDL Laboratories)Class IICIPROFLOXACIN TABLETS, USP, 500 mg, 100 Tablets (10 tablets per blister card. 10 blister cards per carton), Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV --- NDC 51079-182-20.
CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices
- 2015-01-28FDA-Drug3M Company/3m Espe Dental ProductsClass III3M ESPE Clinpro 5000 (1.1% Sodium Flouride), Anti-Cavity Toothpaste, 4 oz tube (NDC 48878-3130-04), Rx Only, Manufactured for 3M ESPE Dental Products, St. Paul, MN 55144
Labeling: Incorrect or Missing Lot and/or Exp. Date - The subject lot is missing the lot number and expiration date stamp on the primary box..
- 2015-01-28FDA-DrugWalgreens Infusion ServicesClass IITotal parenteral nutrition various strengths
Lack of sterility assurance.
- 2015-01-28FDA-DrugWalgreens Infusion ServicesClass IIL-cysteine various strengths
Lack of sterility assurance.
- 2015-01-28FDA-DrugWalgreens Infusion ServicesClass IIImmune globulin g human various strengths
Lack of sterility assurance.
- 2015-01-28FDA-DrugWalgreens Infusion ServicesClass IIDiphenhydramine 50 mg/ml vials
Lack of sterility assurance.
- 2015-01-28FDA-DrugWalgreens Infusion ServicesClass IIDehydrated alcohol vials
Lack of sterility assurance.
- 2015-01-28FDA-DrugWalgreens Infusion ServicesClass IIIDeferoxamine various strengths in normal saline
Lack of sterility assurance.
- 2015-01-28FDA-DrugWalgreens Infusion ServicesClass IIMagnesium sulfate various strengths in sodium chloride
Lack of sterility assurance.
- 2015-01-28FDA-DrugWalgreens Infusion ServicesClass IIRanitidine various strengths in syringes
Lack of sterility assurance.
- 2015-01-28FDA-DrugWalgreens Infusion ServicesClass IIThiamine 100 mg/ ml vials
Lack of sterility assurance.
- 2015-01-28FDA-DrugWalgreens Infusion ServicesClass IIFolic acid 1 mg/ 0.2 ml pre-drawn syringes
Lack of sterility assurance.
- 2015-01-28FDA-DrugWalgreens Infusion ServicesClass IIDopamine various strengths in dextrose
Lack of sterility assurance.
- 2015-01-28FDA-DrugWalgreens Infusion ServicesClass IIDobutamine various strengths in dextrose
Lack of sterility assurance.
- 2015-01-28FDA-DrugWalgreens Infusion ServicesClass IICaspofungin various strengths in normal saline
Lack of sterility assurance.
- 2015-01-28FDA-DrugWalgreens Infusion ServicesClass IIMilrinone various strengths in dextrose
Lack of sterility assurance.
- 2015-01-28FDA-DrugWalgreens Infusion ServicesClass IIAcyclovir various strengths in normal saline
Lack of sterility assurance.
Get notified about new drug recalls
Free weekly digest. We email when a new federal recall in this category — or anything else affecting your household — is published.
Get the Sunday Brief