D-0028-2016 Class III Terminated
FDA drug recall D-0028-2016 was initiated by Ohm Laboratories, Inc. on July 28, 2015 and is designated Class III. Reason for recall: Superpotent Drug: Out Of Specification (OOS) result for Assay. The recall status is terminated (terminated October 28, 2016). Affected quantity: 35,712 boxes.
Recall Details
- Product Type
- Drugs
- Report Date
- October 21, 2015
- Initiation Date
- July 28, 2015
- Termination Date
- October 28, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 35,712 boxes
Product Description
Health Mart Pharmacy loratadine orally disintegrating tablets, USP, 10 mg, 10-count tablets per box, Distributed by: McKesson, One Post Street, San Francisco, CA 94104, NDC 62011-0073-1, UPC 0 5256913369 9
Reason for Recall
Superpotent Drug: Out Of Specification (OOS) result for Assay.
Distribution Pattern
Nationwide.
Code Information
Batch Numbers: 2544488, Exp, 7/31/2016; 2617892, Exp 5/31/2016; 2625092, Exp 6/30/2016