Home / Recalls / Ohm Laboratories, Inc. / D-0027-2016

D-0027-2016 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
N/A

Product Description

Good Neighbor Pharmacy Loratadine Orally Disintegrating Tablets, USP, 10 mg, packaged in a) For kids 10-count tablets per box, NDC 24385-0161-52, ABC # 042-226, UPC 0 8770140650 8; b) For adults 10-count tablets, NDC 46122-0140-52, ABC# 059-535, UPC 0877014065546, Distributed by: AmerisourceBergen, 1300 Morris Drive, Chesterbrook, PA 19087

Reason for Recall

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

Distribution Pattern

Nationwide.

Code Information

Batch Numbers: a) 2625092, Exp 6/30/2016; 2610783, Exp 4/30/2016 b) 2625093, Exp 6/30/2016, 2610783, Exp 4/30/2016

Other recalls by Ohm Laboratories, Inc.

  • D-0022-2016 Class III — CareOne Original Prescription Strength, Allergy Relief, Loratadine Orally Disint (July 28, 2015)
  • D-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-0030-2016 Class III — Leader Loratadine Orally Disintegrating Tablets, USP, 10 mg, 30-count tablets pe (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)