FDAClass IIIOctober 21, 2015

QC Quality Choice Loratadine Orally Disintegrating recall: Superpotent

QC Quality Choice Loratadine Orally Disintegrating Tablets, USP 10 mg, 10-count tablets per box, Distributed by C.D.M.A., Inc., 43157 W. Nine Mile, Novi, MI 48376-0995, NDC 63868-157-10, UPC 6 35515 95777 0

Why was QC Quality Choice Loratadine Orally Disintegrating 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: 2644273, Exp 9/30/2016; 2600127, Exp 3/20/2016; 2544486, Exp 7/31/2016

Product
QC Quality Choice Loratadine Orally Disintegrating Tablets, USP 10 mg, 10-count tablets per box, Distributed by C.D.M.A., Inc., 43157 W. Nine Mile, Novi, MI 48376-0995, NDC 63868-157-10, UPC 6 35515 95777 0
Recalling firm
Ohm Laboratories, Inc.
Quantity
8,735 units
Distribution
Nationwide.
Recall date
October 21, 2015
Classification
Class III
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls