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.
- 2013-01-30FDA-DrugWest-ward Pharmaceutical Corp.Class IILisinopril and Hydrochlorothiazide Tablets, 20 mg/25 mg, packaged in a) 100-count tablets per bottle (NDC 0143-1264-01) and b) 1000-count tablets per bottle (NDC 0143-1264-10), Rx only, Manufactured by: West-ward Pharmaceutical Corp., Eatontown, NJ 07724.
Presence of Foreign Substance: Reports of gray smudges identified as minute stainless steel particulates were found in the recalled tablets.
- 2013-01-30FDA-DrugWest-ward Pharmaceutical Corp.Class IIPropylthiouracil Tablets, USP, 50 mg, packaged in a) 100-count tablets per bottle (NDC 0143-1480-01) and b) 1000-count tablets per bottle (NDC 0143-1480-10), Rx only, Manufactured by: West-ward Pharmaceuticals Corp. Eatontown, NJ 07724.
Presence of Foreign Substance: Uncharacteristic spots identified as steel corrosion, degraded tablet material and hydrocarbon oil with trace amounts of iron were found in tablets.
- 2013-01-30FDA-DrugWest-ward Pharmaceutical Corp.Class IILisinopril Tablets, USP 40 mg, packaged in a) 100-count tablets per bottle (NDC 0143-1270-01); b) 1000-count tablets per bottle (NDC 0143-1270-10); Rx only, Manufactured by: West-ward Pharmaceutical Corp., Eatontown, NJ 07724; and c) 1000-count tablets per bottle (NDC 24658-245-10); Rx only, Manufactured for: Blu Pharmaceuticals, Franklin, KY 42134; Manufactured By: West-ward Pharmaceutical Corp., Eatontown, N.J. 07724.
Presence of Foreign Substance: Uncharacteristic black spots identified as a food grade lubricant with trace amounts of foreign particulates and stainless steel inclusions have been found in the tablets.
- 2013-01-23FDA-DrugJames G. Cole, Inc.Class III-C Drops, Eye Cleansing Agent, 15 ml ASN/Maxam P.O. Box 1277 Hood River, OR 97031
Lack of Assurance of Sterility: The product is being recalled because the product label does not state sterile in accordance with 21 CFR Part 200.50(a)(1), Ophthalmic Preparations and Dispensers, and it is not in compliance with 21 CFR Part 349, Ophthalmic Drug Products for Over-The-Counter Use.
- 2013-01-23FDA-DrugTeva Pharmaceuticals USA, Inc.Class IIICABERGOLINE Tablets, 0.5 mg, RX only, 8 count bottles, Manufactured For: TEVA PHARMACEUTICALS USA, Sellersville, PA 18960 NDC 0093-5420-88
Impurities/Degradation Products: This lot of product will not meet the impurity specification over shelf life
- 2013-01-23FDA-DrugUpsher Smith Laboratories, Inc.Class IIIDivalproex Sodium Delayed-Release Tablets, USP, 500 mg Valproic Acid Activity, 100-count tablets per bottle, Rx only, Manufactured by Upsher-Smith Laboratories, Inc., Minneapolis, MN 55447, NDC 0245-0182-11.
Labeling: Label Error On Declared Strength; Some bottles of product were missing the color-coded strength on the primary display panel of the label.
- 2013-01-23FDA-DrugBoehringer Ingelheim Roxane IncClass IIIPerindopril Erbumine Tablets, 8mg, 100 Tablets per Bottle, Rx Only, Boehringer Ingelheim, Roxane Laboratories Inc., Columbus, OH 43216, NDC 0054-0112-25.
Impurities/Degradation Products: Out of Specification results found for impurity B, identified as the drug's metabolite.
- 2013-01-23FDA-DrugL. Perrigo Co.Class IIPrednisone tablets, USP, 10mg, Rx Only, Units of Use, NDC: a) 45802-303-67, 48-count Cartons, b) 45802-303-21, 21-count Cartons, Manufactured by: West-Ward Pharmaceutical Corporation, Eastown, NJ 07724, Distributed by: Perrigo, Allegan, MI 49040.
Presence of Foreign Substance(s); Perrigo has been notified of a recall by the manufacturer of this product, West-Ward Pharmaceuticals. This is a sub-recall due to tablets contaminated with trace amounts of food-grade lubricant, as well as stainless steel inclusions
- 2013-01-09FDA-DrugNew England Compounding CenterClass IITriamcinolone 10 mg/mL P, 40mg/mL P, 40mg/mL PF and 80 mg/mL PF in 1 mL, 2 mL, 5 mL, and 10 mL vials, manufactured by New England Compounding Center, Framingham, MA
Lack of Assurance of Sterility
- 2013-01-09FDA-DrugNew England Compounding CenterClass IISaline 10% and 3%, in 5 mL and 10 mL vials, manufactured by New England Compounding Center, Framingham, MA
Lack of Assurance of Sterility
- 2013-01-09FDA-DrugNew England Compounding CenterClass IIOmnipaque 240mg/mL PF, 300mg/mL PF, in 3 mL, 5 mL, and 10 mL, vials, manufactured by New England Compounding Center, Framingham, MA
Lack of Assurance of Sterility
- 2013-01-09FDA-DrugNew England Compounding CenterClass IILidocaine 1% PF, 2% PF, and 4% PF, in 1 mL, 2 mL, 5 mL, and 10 mL vials, manufactured by New England Compounding Center, Framingham, MA
Lack of Assurance of Sterility
- 2013-01-09FDA-DrugNew England Compounding CenterClass IILidocaine/Dextrose 5%/7.5% PF, manufactured by New England Compounding Center, Framingham, MA
Lack of Assurance of Sterility
- 2013-01-09FDA-DrugNew England Compounding CenterClass IIIsovue 200 mg/mL PF and 300 mg/mL PF, Vials, manufactured by New England Compounding Center, Framingham, MA
Lack of Assurance of Sterility
- 2013-01-09FDA-DrugNew England Compounding CenterClass IIHyaluronidase 150 u/ml PF, 1 mL, 5 mL, and 10 mL vials, manufactured by New England Compounding Center, Framingham, MA
Lack of Assurance of Sterility
- 2013-01-09FDA-DrugNew England Compounding CenterClass IIGlycerin 100% PF, 1mL, 2 mL, and 5 mL vials, manufactured by New England Compounding Center, Framingham, MA
Lack of Assurance of Sterility
- 2013-01-09FDA-DrugNew England Compounding CenterClass IIDexamethasone Sodium Phosphate 4 mg/mL vials PF, 6 mg/mL PF vials, and 8 mg/mL PF vials, manufactured by New England Compounding Center, Framingham, MA
Lack of Assurance of Sterility
- 2013-01-09FDA-DrugNew England Compounding CenterClass IIClonidine 100 mcg/mL PF, 1mL and 2 mL vials, manufactured by New England Compounding Center, Framingham, MA
Lack of Assurance of Sterility
- 2013-01-09FDA-DrugNew England Compounding CenterClass IIBupivacaine 0.25% PF, Bupivacaine 0.5% PF, and Bupivacaine 0.75% PF, manufactured by New England Compounding Center, Framingham, MA
Lack of Assurance of Sterility
- 2013-01-09FDA-DrugNew England Compounding CenterClass IIBetamethasone Sodium Phosphate 6 mg/mL P Injection, Betamethasone Sodium Phosphate 6 mg/mL PF Injection, Betamethasone Sodium Phosphate 8 mg/mL PF Injection, Betamethasone Sodium Phosphate 12 mg/mL PF Injection, manufactured by New England Compounding Center, Framingham, MA
Lack of Assurance of Sterility
- 2013-01-09FDA-DrugNew England Compounding CenterClass IIBetamethasone Repository 6 mg/mL PF Injection and Betamethasone Repository 6 mg/mL P Injection, manufactured by New England Compounding Center, Framingham, MA
Lack of Assurance of Sterility
- 2013-01-09FDA-DrugNew England Compounding CenterClass IMethylprednisolone Acetate 80 mg/mL Injection, Preserved, supplied in 5 mL and 10 mL vials, manufactured by New England Compounding Center, Framingham, MA
Non-Sterility
- 2013-01-09FDA-DrugNew England Compounding CenterClass IMethylprednisolone Acetate 40 mg/mL Injection, Preserved, supplied in 5 mL and 10 mL vials, manufactured by New England Compounding Center, Framingham, MA
Non-Sterility
- 2013-01-09FDA-DrugNew England Compounding CenterClass IMethylprednisolone Acetate (PF) 40 mg/ml Injection, supplied in 1 mL, 2 mL and 5 mL vials, manufactured by New England Compounding Center, Framingham, MA
Non-Sterility
- 2013-01-09FDA-DrugNew England Compounding CenterClass IMethylprednisolone Acetate (PF) 80 mg/ml Injection, supplied in 1 mL, 2 mL and 5 mL vials, manufactured by New England Compounding Center, Framingham, MA
Non-Sterility
- 2013-01-09FDA-DrugAbbott LaboratoriesClass IISynthroid (Levothyroxine Sodium) tablets, 150 mcg (0.15 mg), 90 tablets per bottle, Rx Only, NDC 0074-7069-90; ABBOTT LABORATORIES NORTH CHICAGO, IL 60064 U.S.A.
Labeling: Error on Declared Strength. Product labeled to contain 150 mcg tablets actually contained 75 mcg tablets.
- 2013-01-09FDA-DrugHospira Inc.Class IIEpinephrine Injection USP, 1 mL, USP 1:1000 (1 mg/mL), SQ/IM, Hospira, Inc., Lake Forest, IL --- NDC 0409-7241-01
Presence of Particulates; may contain glass particles
- 2013-01-02FDA-DrugF. Hoffmann-LaRoche Ltd.Class IICymevene 500 mg Powder for Infusion, (ganciclovir), 50 mg/mL ganciclovir (reconstructed), Rx only, 10 mL vials, Roche Products Limited, Welwyn Garden City, AL7 1TW, United Kingdom
Lack of Assurance of Sterility; container closure issues with the bulk batch.
- 2013-01-02FDA-DrugAlara Pharmaceutical CoClass IILevothyroxine Sodium Tablets, USP, 175 mcg in 90 ct bottles, Manufactured by Patheon Puerto Rico Inc., for Alara Pharmaceutical Corp, San Juan, PR
Subpotent; 15 month stability
- 2013-01-02FDA-DrugLloyd Inc. of IowaClass IILevothroid (levothyroxine sodium tablets, USP), 75 mcg., 100-count bottles, Rx only, NDC 0456-1322-01, Manufactured for Forest Pharmaceuticals, Inc., Subsidiary of Forest Laboratories, Inc., St. Louis, MO, by Lloyd Pharmaceutical, Shenandoah, IA.
Subpotent; 9-month stability interval
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