FDA recall D-1042-2014

Product

Pantaprazole Sodium Delayed Release Tablets , USP 40 mg, 1000 tablets bottle, Rx only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd Parsippany, NJ 07054 USA. NDC: 64679-0434-02.

Reason for recall

Failed Dissolution Specifications; 12 month acid dissolution test results were above upper limit specifications.

Distribution

Nationwide including Puerto Rico

Key facts

Status

Terminated

Initiation date

2013-11-27

Report date

2014-02-05

Termination date

2015-01-29

Voluntary/Mandated

Voluntary: Firm initiated

Location

Parsippany, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1042-2014