PlainRecalls
FDA Drug Low Class III Terminated

Fred's Loratadine Orally Disintegrating Tablets, USP, 10 mg, 30-counts tablets per box, Distributed by: fred's, Inc., 4300 New Getwell Road, Memphis, TN 38118, UPC 0 8457912198 4.

Reported: October 21, 2015 Initiated: July 28, 2015 #D-0026-2016

Product Description

Fred's Loratadine Orally Disintegrating Tablets, USP, 10 mg, 30-counts tablets per box, Distributed by: fred's, Inc., 4300 New Getwell Road, Memphis, TN 38118, UPC 0 8457912198 4.

Reason for Recall

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

Details

Recalling Firm
Ohm Laboratories, Inc.
Units Affected
12,960 boxes
Distribution
Nationwide.
Location
North Brunswick, NJ

Frequently Asked Questions

What product was recalled?
Fred's Loratadine Orally Disintegrating Tablets, USP, 10 mg, 30-counts tablets per box, Distributed by: fred's, Inc., 4300 New Getwell Road, Memphis, TN 38118, UPC 0 8457912198 4.. Recalled by Ohm Laboratories, Inc.. Units affected: 12,960 boxes.
Why was this product recalled?
Superpotent Drug: Out Of Specification (OOS) result for Assay.
Which agency issued this recall?
This recall was issued by the FDA Drug on October 21, 2015. Severity: Low. Recall number: D-0026-2016.