FDAClass IIIOctober 21, 2015

Premier Value Loratadine Orally Disintegrating Tablets recall: Superpotent

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

Why was Premier Value Loratadine Orally Disintegrating Tablets recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Batch Numbers: 2600126, Exp 2/29/2016; 2644273, Exp 9/30/2016

Product
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
Recalling firm
Ohm Laboratories, Inc.
Quantity
11,232 boxes
Distribution
Nationwide.
Recall date
October 21, 2015
Classification
Class III
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls