FDA recall D-0022-2016

Ohm Laboratories, Inc. · Class III · drug

Product

CareOne Original Prescription Strength, Allergy Relief, Loratadine Orally Disintegrating Tablets, USP, 10 mg, packaged in a) 10-count tablets per box, NDC 41520-525-69, UPC 3 41520 31346 2; b) Children's 10-count tablets per box NDC 41520-527-69, UPC 3 41520 31455 1; Distributed by: American Sales Company, 4201 Walden Avenue, Lancaster, NY 14086

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-0022-2016