PlainRecalls
FDA Drug Low Class III Terminated

Premier Value Loratadine Orally Disintegrating Tablets, USP, 10 mg, 30-count tablets per box; Distributed by Chain Drug Consortium, 3301 NW Boca Raton Blvd. Suite 101, Boca Raton, FL 33431, NDC 68016-527-31, UPC 8 4098601899 2

Reported: October 21, 2015 Initiated: July 28, 2015 #D-0033-2016

Product Description

Premier Value Loratadine Orally Disintegrating Tablets, USP, 10 mg, 30-count tablets per box; Distributed by Chain Drug Consortium, 3301 NW Boca Raton Blvd. Suite 101, Boca Raton, FL 33431, NDC 68016-527-31, UPC 8 4098601899 2

Reason for Recall

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

Details

Recalling Firm
Ohm Laboratories, Inc.
Units Affected
11,232 boxes
Distribution
Nationwide.
Location
North Brunswick, NJ

Frequently Asked Questions

What product was recalled?
Premier Value Loratadine Orally Disintegrating Tablets, USP, 10 mg, 30-count tablets per box; Distributed by Chain Drug Consortium, 3301 NW Boca Raton Blvd. Suite 101, Boca Raton, FL 33431, NDC 68016-527-31, UPC 8 4098601899 2. Recalled by Ohm Laboratories, Inc.. Units affected: 11,232 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-0033-2016.