Recall: D-0032-2016

Class III - Minor Violations

Class IIIClassification

2015-07-28Initiated

TerminatedStatus

Ohm Laboratories, Inc.Firm

Product

Ohm Loratadine Orally Disintegrating Tablets, USP, 10 mg, 30-count tablets, Distributed by Ohm Laboratories, Inc. 1385 Livingston Avenue, North Brunswick, NJ 08902, NDC 51660-527-31, UPC 3 5166052731 5

Reason

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

Distribution

Nationwide.

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.