Home / Recalls / Ohm Laboratories, Inc. / D-0037-2016

D-0037-2016 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

Sunmark loratadine Orally Disintegrating Tablets, USP, 10 mg, packaged in a) 10-count tablets per box (NDC 49348-930-01, UPC 0 1093936544 6); and b) 30-count tablets per box (NDC 49348-930-44, UPC 0 1093934944 6) Distributed by McKesson, One Post Street, San Francisco, CA 94104

Reason for Recall

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

Distribution Pattern

Nationwide.

Code Information

Batch Numbers: (a) 2544488, Exp 7/31/2016; 26917891, Exp 5/31/2016. (b) 2544488, Exp 7/31/2016; 2617893, Exp 5/31/2016; 2644273, Exp 9/30/2016

Other recalls by Ohm Laboratories, Inc.

  • D-0021-2016 Class III — Health Best Choice Care, Loratadine Orally Disintegrating Tablets, USP, 10 mg, (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-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-0022-2016 Class III — CareOne Original Prescription Strength, Allergy Relief, Loratadine Orally Disint (July 28, 2015)