PlainRecalls
FDA Drug Low Class III Terminated

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

Reported: October 21, 2015 Initiated: July 28, 2015 #D-0019-2016

Product Description

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

Reason for Recall

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

Details

Recalling Firm
Ohm Laboratories, Inc.
Units Affected
8,735 units
Distribution
Nationwide.
Location
North Brunswick, NJ

Frequently Asked Questions

What product was recalled?
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. Recalled by Ohm Laboratories, Inc.. Units affected: 8,735 units.
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-0019-2016.