Drug recall D-0032-2016

Class III Terminated reported Oct 21, 2015

Product

Ohm Loratadine Orally Disintegrating Tablets, USP, 10 mg, 30-count tablets, Distributed by Ohm Laboratories, Inc. 1385 Livingston Avenue, North Brunswick, NJ 08902, NDC 51660-527-31, UPC 3 5166052731 5

Reason for recall

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

Lots and codes

Batch Numbers: 2544486, Exp 7/31/2016; 2617891, Exp 5/31/2016; 2644272, Exp 9/30/2016

Recall details

Recalling firm
Ohm Laboratories, Inc., North Brunswick, NJ
Quantity
311 boxes
Distribution
Nationwide.
Type
Voluntary: Firm initiated
Recall initiated
July 28, 2015
Terminated
October 28, 2016

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