FDA recall D-0029-2016

Product

HEB Loratadine Orally Disintegrating Tablets, USP, 10 mg, 10-count tablets per box, Made with pride & care for HEB, San Antonio, TX 78204, Item code: 188330, UPC 0 4122081968 3

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-0029-2016