FDA recall D-0028-2016

Product

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

Nationwide.

Key facts

Status

Terminated

Initiation date

2015-07-28

Report date

2015-10-21

Termination date

2016-10-28

Voluntary/Mandated

Voluntary: Firm initiated

Location

North Brunswick, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0028-2016