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  1. FDA Recalls
  2. ›Drug Recalls

FDA Drug Recalls

Recalls of prescription drugs, over-the-counter medications, and compounded pharmaceuticals.

Classification
AllClass IClass IIClass III
Status
AllOngoingCompletedTerminated
Date
All timePast 30 daysPast 12 months

Showing 14741–14760 of 17,832 recalls

Class IITerminated

Whitfield's OINTMENT B.P., Net Contents: 15g. Manufactured by: NEW GPC INC. A1 Farm, EBD. Country of Origin Guyana.

New Gpc Inc.

Does Not Meet Monograph: NEW GPC INC. has recalled multiple Over-the-Counter Drug Products due to lack of drug listing, lack of OTC drug labeling requirements and labeled Not Approved for sale in U.S.A.

August 7, 2014 · FDAView details →
Class IITerminated

Rector's Remedy OINTMENT, Net Contents: 15g. Manufactured by: NEW GPC INC. A1 Farm, EBD. Country of Origin Guyana.

New Gpc Inc.

Does Not Meet Monograph: NEW GPC INC. has recalled multiple Over-the-Counter Drug Products due to lack of drug listing and lack of OTC drug labeling requirements.

August 7, 2014 · FDAView details →
Class IITerminated

WHITFIELD LOTION, Net Contents: 60 mL. Manufactured by: NEW GPC INC. A1 Farm, EBD. Country of Origin Guyana.

New Gpc Inc.

Does Not Meet Monograph: NEW GPC INC. has recalled multiple Over-the-Counter Drug Products due to lack of drug listing, lack of OTC drug labeling requirements and labeled Not Approved for sale in U.S.A..

August 7, 2014 · FDAView details →
Class IITerminated

Ferrol EXPECTORANT, Net Contents: 100 mL. Product packaged within a plastic bottle individually placed in small blue carton. Manufactured by: NEW GPC INC. A1 Farm, EBD. Country of Origin Guyana.

New Gpc Inc.

Does Not Meet Monograph: NEW GPC INC. has recalled multiple Over-the-Counter Drug Products due to lack of drug listing, lack of OTC drug labeling requirements and labeled Not Approved for sale in U.S.A..

August 7, 2014 · FDAView details →
Class IITerminated

Alcohol-Free Hand Sanitizer, 1. fl. oz. (30 ml) bottles capped with white sprayer, OTC, contains Benzalkonium chloride. Mfg. for HLI, Portland, OR 97222 NDC: 19392-120-03. Labeled A) Anne Arundel County Mental Health Agency, Inc., B) Family Advocacy Program, and C) Henderson Community College Nursing.

HLI dba Humphreyline Inc

Microbial Contamination of Non-Sterile Product

August 6, 2014 · DrugView details →
Class IITerminated

CHILDREN'S Q-PAP, Acetaminophen, ORAL SUSPENSION, GRAPE FLAVOR, Active ingredient (in each 5 mL = 1 tsp) Acetaminophen USP 160 mg, 4 FL OZ (118 mL), Made in the USA for Qualitest Pharmaceuticals, Huntsville, AL 35811, NDC 0603-0843-54, OTC

Qualitest Pharmaceuticals

Superpotent Drug: Qualitest Pharmaceuticals is initiating a recall of three flavors of Acetaminophen Oral Suspension Liquid 160mg/5mL for failure of the product assay at the 12 month timepoint.

August 6, 2014 · DrugView details →
Class IITerminated

CHILDREN'S Q-PAP, Acetaminophen, ORAL SUSPENSION, BUBBLE GUM FLAVOR, Active ingredient (in each 5 mL = 1 tsp) Acetaminophen USP 160 mg, 4 FL OZ (118 mL), Made in the USA for Qualitest Pharmaceuticals, Huntsville, AL 35811, NDC 0603-0841-54, OTC

Qualitest Pharmaceuticals

Superpotent Drug: Qualitest Pharmaceuticals is initiating a recall of three flavors of Acetaminophen Oral Suspension Liquid 160mg/5mL for failure of the product assay at the 12 month timepoint.

August 6, 2014 · DrugView details →
Class IITerminated

CHILDREN'S Q-PAP, Acetaminophen, ORAL SUSPENSION, CHERRY FLAVOR, Active ingredient (in each 5 mL = 1 tsp) Acetaminophen USP 160 mg, 4 FL OZ (118 mL), Made in the USA for Qualitest Pharmaceuticals, Huntsville, AL 35811, NDC 0603-0842-54, OTC

Qualitest Pharmaceuticals

Superpotent Drug: Qualitest Pharmaceuticals is initiating a recall of three flavors of Acetaminophen Oral Suspension Liquid 160mg/5mL for failure of the product assay at the 12 month timepoint.

August 6, 2014 · DrugView details →
Class IIITerminated

Rifampin for Injection USP, 600 mg*/vial (Sterile), supplied in sterile glass vials, Rx only For IV Infusion only, individually boxed, Mfd. for: Akorn, Inc., Lake Forest, IL --- NDC 17478-151-42

Akorn, Inc.

Failed Impurity/Degradation Specification; high out of specification result for 23 transacetyl impurity at the 22 month stability time point

August 5, 2014 · DrugView details →
Class IITerminated

ZyGenerics ATENOLOL Tablets, USP 25 mg 1000 count bottle, Rx Only Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08634 USA NDC 68382-022-01

Zydus Pharmaceuticals USA Inc

Superpotent Drug: A complaint was reported by a pharmacist who stated several tablets were noticeably thicker in appearance.

August 5, 2014 · DrugView details →
Class IITerminated

ProSol - sulfite-free (Amino Acid) Injection, 20%, 2000 mL VIAFLEX container bag, Rx only, Baxter Healthcare Corporation, Clinitec Nutrition Division, Deerfield, IL 60015 USA, Product Code 2B6186, NDC 0338-0499-06.

Baxter Healthcare Corp

Presence of Particulate Matter: identification of particulates in a retention sample that have been identified as a mixture of the amino acid leucine and inorganic material (containing iron, silicone and chlorine).

August 4, 2014 · DrugView details →
Class ITerminated

CUBICIN (daptomycin for injection), 500 mg single-use vial, Rx only, Manufactured for: Cubist Pharmaceuticals, Inc., Lexington, MA 02421, NDC 67919-011-01, UPC 3 67919-011-01 6.

Cubist Pharmaceuticals, Inc.

Presence of Particulate Matter: Potential presence of glass particulate matter in the vials.

August 1, 2014 · DrugView details →
Class IITerminated

CYTARAbine for Injection USP, lyophiled in glass vials, 1 gram per vial, Rx only, Distributed by Bedford Laboratories, Bedford, OH 44146, Manufactured by Ben Venue Labs, Inc., Bedford, OH 44146, NDC 55390-808-01

Ben Venue Laboratories Inc

Lack of Assurance of Sterility: Crimp defects during visual inspection could affect container closure integrity.

July 31, 2014 · DrugView details →
Class IITerminated

Alprazolam Tablets, USP 0.25 mg, UD 100 Tablets (10 x 10), Rx Only, Mfg By: Sandoz, Inc., Princeton, NJ 08540 --- NDC 63739-644-10

Mckesson Packaging Services

Presence of Foreign Substance; tablets may contain stainless steel metal particulates

July 30, 2014 · DrugView details →
Class IITerminated

0.9% Sodium Chloride Injection, USP, 500 mL, VIAFLEX Plastic Container, Baxter Healthcare Corporation, Deerfield, IL NDC 0338-0049-03

Baxter Healthcare Corp.

Lack of Assurance of Sterility; complaints of mold in the overpouch

July 30, 2014 · DrugView details →
Class IIITerminated

Depo-Medrol (methylprednisolone acetate injectable suspension USP), 40 mg/ mL, 1 mL Single-Dose Vial, Rx only, Distributed by Pharmacia & Upjohn Co Division of Pfizer Inc, New York NY 10017 NDC 0009-3073-03 DEPO-MEDROL methylprednisolone acetate Injectable Suspension USP, 40 mg per mL, 1 mL Single-Dose Vial, Rx ONLY, Distributed by Pharmacia & Upjohn Co Division of Pfizer Inc, New York NY 10017, NOVAPLUS is a registered trademark of Novation, LLC NDC 0009-3073-23

Pfizer Inc.

Failed pH Specification: A pH result of 2.9 was obtained at the 9 month stability test interval at 25C/60%RH. The registered specification for pH is 3.0 - 7.0

July 30, 2014 · DrugView details →
Class IIITerminated

Cataflam (diclofenac potassium) tablets, 50 mg, 100-count bottles, Rx only, Manufactured by: Patheon Inc., Whitby Operations, Ontario, Canada L1N 5Z5; Distributed by: Novartis Pharmaceuticals Corp., East Hanover, New Jersey 07936; NDC 0078-0436-05, UPC 3 0078-0436-05 2.

Novartis Pharmaceuticals Corp.

Failed Tablet/Capsule Specifications: Ink identification had rubbed off tablets in transit making them illegible to pharmacists and consumers.

July 30, 2014 · DrugView details →
Class ITerminated

Lidocaine HCl Injection, USP, 2%, 20 mg per mL, Preservative-Free, 5 mL Single-Dose Vial, Rx only, For Infiltration and Nerve Block including Epidural and Caudal, Manufactured by: Hospira, Inc., Lake Forest, IL, 60045, NDC 0409-2066-05

Hospira Inc.

Presence of Particulate Matter: The product was discolored and contained visible particulates (iron oxide) in the solution and embedded in the glass vial.

July 29, 2014 · DrugView details →
Class IIITerminated

OXYCODONE HYDROCHLORIDE C II Oral Solution USP, 5 mg/5 mL, 15 mL Vial, Rx only. Boehringer Ingelheim, Roxane Laboratories. Roxane Laboratories, Inc. Columbus, Ohio 43216. NDC: 0054-0523-41.

Boehringer Ingelheim Roxane Inc

Failed Stability Specifications: Out of specification result for preservative sodium benzoate.

July 28, 2014 · DrugView details →
Class IITerminated

Alprazolam Tablets, USP, 0.25mg, Rx only, 1000 tablets, Sandoz Inc., Princeton, NJ --- NDC 0781-1061-10

Sandoz Incorporated

Presence of Foreign Substance; tablets may contain stainless steel metal particulates

July 25, 2014 · DrugView details →
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