FDA recall D-0975-2015

Product

Captopril Tablets, USP 12.5 mg, Rx Only, a) 100 count bottles NDC 64679-902-01, b) 1000 count bottles NDC 64679-902-02, Manufactured by Wockhardt Limited, Mumbai, India, Distributed by: Wockhardt USA LLC., 20 Waterview Boulevard, Parsippany, NJ 07054 USA

Reason for recall

Failed Tablet/Capsule Specifications: out of specification for thickness.

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2015-03-12

Report date

2015-05-13

Termination date

2017-12-14

Voluntary/Mandated

Voluntary: Firm initiated

Location

Parsippany, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0975-2015