Home / Recalls / Ohm Laboratories, Inc. / D-0031-2016

D-0031-2016 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
29,360 boxes

Product Description

Major loratadine orally disintegrating tablets, USP, 10 mg, 10-count tablets per box, Distributed by Major Pharmaceuticals 31778 Enterprise Drive, Livonia, MI 48150, USA, NDC 0904-5806-15, UPC 3 0904580615 9

Reason for Recall

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

Distribution Pattern

Nationwide.

Code Information

Batch Numbers: 2644265, Exp 9/30/2016; 2658140, Exp 11/30/2016; 2625092, 2617891, Exp 5/31/2016; 2600127, Exp 2/29/2016; 2544488, 2544486, Exp 7/31/2016

Other recalls by Ohm Laboratories, Inc.

  • D-0032-2016 Class III — Ohm Loratadine Orally Disintegrating Tablets, USP, 10 mg, 30-count tablets, Dist (July 28, 2015)
  • 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-0036-2016 Class III — Up&Up loratadine orally disintegrating tablets, USP, 10 mg, 30-count tablets per (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-0030-2016 Class III — Leader Loratadine Orally Disintegrating Tablets, USP, 10 mg, 30-count tablets pe (July 28, 2015)