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FDA Drug Recalls

1,523 recalls · Class III, newest first

Class III · Low risk Terminated Jul 28, 2015

Safeway Care Loratadine Orally Disintegrating Tablets, USP, 10 mg, packaged in a) 10-count tablets per box (NDC 21130-527-69, UPC…

Reason Superpotent Drug: Out Of Specification (OOS) result for Assay.

Ohm Laboratories, Inc. NDC 21130-527-69 D-0034-2016

Class III · Low risk Terminated Jul 28, 2015

Premier Value Loratadine Orally Disintegrating Tablets, USP, 10 mg, 30-count tablets per box; Distributed by Chain Drug…

Reason Superpotent Drug: Out Of Specification (OOS) result for Assay.

Ohm Laboratories, Inc. NDC 68016-527-31 D-0033-2016

Class III · Low risk Terminated Jul 28, 2015

Ohm Loratadine Orally Disintegrating Tablets, USP, 10 mg, 30-count tablets, Distributed by Ohm Laboratories, Inc. 1385 Livingston…

Reason Superpotent Drug: Out Of Specification (OOS) result for Assay.

Ohm Laboratories, Inc. NDC 51660-527-31 D-0032-2016

Class III · Low risk Terminated Jul 28, 2015

Major loratadine orally disintegrating tablets, USP, 10 mg, 10-count tablets per box, Distributed by Major Pharmaceuticals 31778…

Reason Superpotent Drug: Out Of Specification (OOS) result for Assay.

Ohm Laboratories, Inc. NDC 0904-5806-15 D-0031-2016

Class III · Low risk Terminated Jul 28, 2015

Leader Loratadine Orally Disintegrating Tablets, USP, 10 mg, 30-count tablets per box, Distributed by Cardinal Health, Dublin, OH…

Reason Superpotent Drug: Out Of Specification (OOS) result for Assay.

Ohm Laboratories, Inc. NDC 37205-745-65 D-0030-2016

Class III · Low risk Terminated Jul 28, 2015

HEB Loratadine Orally Disintegrating Tablets, USP, 10 mg, 10-count tablets per box, Made with pride & care for HEB, San Antonio…

Reason Superpotent Drug: Out Of Specification (OOS) result for Assay.

Ohm Laboratories, Inc. D-0029-2016

Class III · Low risk Terminated Jul 28, 2015

Health Mart Pharmacy loratadine orally disintegrating tablets, USP, 10 mg, 10-count tablets per box, Distributed by: McKesson…

Reason Superpotent Drug: Out Of Specification (OOS) result for Assay.

Ohm Laboratories, Inc. NDC 62011-0073-1 D-0028-2016

Class III · Low risk Terminated Jul 28, 2015

Good Neighbor Pharmacy Loratadine Orally Disintegrating Tablets, USP, 10 mg, packaged in a) For kids 10-count tablets per box…

Reason Superpotent Drug: Out Of Specification (OOS) result for Assay.

Ohm Laboratories, Inc. NDC 24385-0161-52 D-0027-2016

Class III · Low risk Terminated Jul 28, 2015

Fred's Loratadine Orally Disintegrating Tablets, USP, 10 mg, 30-counts tablets per box, Distributed by: fred's, Inc., 4300 New…

Reason Superpotent Drug: Out Of Specification (OOS) result for Assay.

Ohm Laboratories, Inc. D-0026-2016

Class III · Low risk Terminated Jul 28, 2015

Equaline Original Prescription Strength, loratadine orally disintegrating tablets, USP, 10 mg, packaged in a) 10-count tablets…

Reason Superpotent Drug: Out Of Specification (OOS) result for Assay.

Ohm Laboratories, Inc. NDC 41163-528-69 D-0025-2016

Class III · Low risk Terminated Jul 28, 2015

Discount Drug Mart Food Fair, Original Prescription Strength, Loratadine Orally Disintegrating Tablets, USP, 10 mg, 30-count…

Reason Superpotent Drug: Out Of Specification (OOS) result for Assay.

Ohm Laboratories, Inc. D-0024-2016

Class III · Low risk Terminated Jul 28, 2015

CVS Pharmacy, Original Prescription Strength, LORATADINE ORALLY DISINTEGRATING TABLETS, USP, 10 mg, packaged in a) 10-count…

Reason Superpotent Drug: Out Of Specification (OOS) result for Assay.

Ohm Laboratories, Inc. D-0023-2016

Class III · Low risk Terminated Jul 28, 2015

CareOne Original Prescription Strength, Allergy Relief, Loratadine Orally Disintegrating Tablets, USP, 10 mg, packaged in a)…

Reason Superpotent Drug: Out Of Specification (OOS) result for Assay.

Ohm Laboratories, Inc. NDC 41520-525-69 D-0022-2016

Class III · Low risk Terminated Jul 28, 2015

Health Best Choice Care, Loratadine Orally Disintegrating Tablets, USP, 10 mg, 10-count tablets per box, Proudly Distributed…

Reason Superpotent Drug: Out Of Specification (OOS) result for Assay.

Ohm Laboratories, Inc. D-0021-2016

Class III · Low risk Terminated Jul 28, 2015

Rite Aid Pharmacy loratadine orally disintegrating tablets USP, 10 mg, packaged in a) 30-count tablets per box, Item 352712, UPC…

Reason Superpotent Drug: Out Of Specification (OOS) result for Assay.

Ohm Laboratories, Inc. D-0020-2016

Class III · Low risk Terminated Jul 28, 2015

QC Quality Choice Loratadine Orally Disintegrating Tablets, USP 10 mg, 10-count tablets per box, Distributed by C.D.M.A., Inc…

Reason Superpotent Drug: Out Of Specification (OOS) result for Assay.

Ohm Laboratories, Inc. NDC 63868-157-10 D-0019-2016

Class III · Low risk Terminated Jul 24, 2015

Nisoldipine Extended Release Tablets, 17 mg, packaged as a) Sular (nisoldipine) Extended Release tablets, 100-count bottle (NDC…

Reason Failed Dissolution Specifications

Shionogi Inc. NDC 59630-501-10 D-1284-2015

Class III · Low risk Terminated Jul 21, 2015

Verapamil Hydrochloride Extended-Release tablets, USP, 240 mg, 500-count bottles, Rx Only, Apotex Corp. Manufactured by Apotex…

Reason Failed Dissolution Specification: One lot of product did not meet the first stage dissolution specification limits.

Apotex Inc. NDC 60505-2742-5 D1834-2015

Class III · Low risk Terminated Jul 21, 2015

Phentermine Hydrochloride Capsules, USP, 15 mg, packaged in a) 7-count (NDC 55289-791-07), b) 14-count (NDC 55289-791-14), c)…

Reason Failed impurities/Degradation specifications: out of specification results for individual unknown and total impurity at the 12th month room…

PD-Rx Pharmaceuticals, Inc. NDC 55289-791-07 D-0574-2016

Class III · Low risk Terminated Jul 20, 2015

ALLOPURINOL TABLETS, USP, 300 mg, 500 count bottle, Rx only, Manufactured for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811…

Reason Failed Tablet/Capsule Specifications; report of oversized and discolored tablets

Qualitest Pharmaceuticals NDC 0603-2116-28 D-1405-2015

Class III · Low risk Terminated Jul 17, 2015

buPROPion Hydrochloride Extended-¿release Tablets USP (SR), 200 mg, Twice-A-Day, Rx Only, 60 count Bottle, Distributed by: Sun…

Reason Failed Dissolution Specification: During analysis of the 18 month long term stability testing, it was noticed that the drug release results at the 4…

Sun Pharma Global Fze NDC 47335-738-86 D-1345-2015

Class III · Low risk Terminated Jul 16, 2015

Imipramine HCl Tablets, USP, 50 mg, 100 count bottles, Mfd By: Mutual Pharmaceutical Co., Inc., Philadelphia, PA --- NDC…

Reason Chemical Contamination; benzophenone leached from the product label varnish

Mutual Pharmaceutical Company, Inc. NDC 54738-914-01 D-1425-2015

Class III · Low risk Terminated Jul 16, 2015

Imipramine HCl Tablets, USP, 25 mg, 100 count bottles, Mfd By: Mutual Pharmaceutical Co., Inc., Philadelphia, PA --- NDC…

Reason Chemical Contamination; benzophenone leached from the product label varnish

Mutual Pharmaceutical Company, Inc. NDC 54738-913-01 D-1424-2015

Class III · Low risk Terminated Jul 16, 2015

Imipramine HCl Tablets, USP, 10 mg, 100 count bottles, Rx only, Mfd By: Mutual Pharmaceutical Co. Inc., Philadelphia, PA --- NDC…

Reason Chemical Contamination; benzophenone leached from the product label varnish

Mutual Pharmaceutical Company, Inc. NDC 54738-912-01 D-1423-2015

Class III · Low risk Terminated Jul 16, 2015

Felodipine Extended-Release Tablets, 10 mg, 100 count bottles, Rx only, Mutual Pharmaceutical Co Inc., Philadelphia, PA --- NDC…

Reason Chemical Contamination; benzophenone leached from the product label varnish

Mutual Pharmaceutical Company, Inc. NDC 53489-370-01 D-1422-2015