FDA recall D-0239-2015

Physicians Total Care, Inc. · Class III · drug

Product

Loratadine 24 HR-OTC,10 mg, 30-count bottle, Manufactured by Novartis Consumer Health, Parsippany, NJ 07054, Distributed by Physicians Total Care, Tulsa OK 74146, NDC 54868-5268-00

Reason for recall

Failed Tablet/Capsule Specifications: Affected lot numbers may contain chipped or broken tablets.

Distribution

Nationwide

Key facts

Status: Terminated
Initiation date: 2013-09-11
Report date: 2014-11-12
Termination date: 2015-02-04
Voluntary/Mandated: Voluntary: Firm initiated
Location: Tulsa, OK, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0239-2015