FDA recall D-1110-2015

Product

Clarithromycin Tablets, USP, 500 mg, 20 Tablets, Rx Only, Dist. By: Wockhardt USA LLC, Parsippany, NJ 07054, Repackaged By: Blenheim Pharmacal Inc. North Blenheim, NY 12131, NDC 10544-522-20, MFG: 64679-904-02

Reason for recall

cGMP Deviations; products being recalled in response to a recall notice from the manufacturer, Wockhardt Limited, following a FDA inspection which noted inadequate investigation of market complaints, resulting in unsuccessful identification of root causes, and the investigation not being expanded to prevent repeat failure

Distribution

Indiana

Key facts

Status

Terminated

Initiation date

2015-05-22

Report date

2015-06-03

Termination date

2016-01-15

Voluntary/Mandated

Voluntary: Firm initiated

Location

North Blenheim, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1110-2015