Home / Recalls / Ohm Laboratories, Inc. / D-0030-2016

D-0030-2016 Class III Terminated

Recalled by Ohm Laboratories, Inc. — North Brunswick, NJ

Recall Details

Product Type: Drugs
Report Date: October 21, 2015
Initiation Date: July 28, 2015
Termination Date: October 28, 2016
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 9,624 boxes

Product Description

Leader Loratadine Orally Disintegrating Tablets, USP, 10 mg, 30-count tablets per box, Distributed by Cardinal Health, Dublin, OH 43017, NDC 37205-745-65, UPC 0 9629512322 7

Reason for Recall

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

Distribution Pattern

Nationwide.

Code Information

Batch Numbers: 2617891, Exp 5/31/2016; 2625092, Exp 6/30/2016

Other recalls by Ohm Laboratories, Inc.

D-0022-2016 Class III — CareOne Original Prescription Strength, Allergy Relief, Loratadine Orally Disint (July 28, 2015)
D-0027-2016 Class III — Good Neighbor Pharmacy Loratadine Orally Disintegrating Tablets, USP, 10 mg, pac (July 28, 2015)
D-0026-2016 Class III — Fred's Loratadine Orally Disintegrating Tablets, USP, 10 mg, 30-counts tablets p (July 28, 2015)
D-0039-2016 Class III — Meijer Loratadine Orally Disintegrating Tablets, USP, 10 mg, 30-count tablets pe (July 28, 2015)
D-0034-2016 Class III — Safeway Care Loratadine Orally Disintegrating Tablets, USP, 10 mg, packaged in a (July 28, 2015)
D-0028-2016 Class III — Health Mart Pharmacy loratadine orally disintegrating tablets, USP, 10 mg, 10-co (July 28, 2015)
D-0038-2016 Class III — Wal-itin Loratadine Orally Disintegrating Tablets, USP, 10 mg, packaged in a) 10 (July 28, 2015)
D-0024-2016 Class III — Discount Drug Mart Food Fair, Original Prescription Strength, Loratadine Orally (July 28, 2015)
D-0021-2016 Class III — Health Best Choice Care, Loratadine Orally Disintegrating Tablets, USP, 10 mg, (July 28, 2015)
D-0029-2016 Class III — HEB Loratadine Orally Disintegrating Tablets, USP, 10 mg, 10-count tablets per b (July 28, 2015)