PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: May 13, 2015 Initiated: March 12, 2015 #D-0975-2015

Product Description

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.

Details

Recalling Firm
Wockhardt Usa Inc.
Units Affected
93,393 bottles
Distribution
Nationwide
Location
Parsippany, NJ

Frequently Asked Questions

What product was recalled?
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. Recalled by Wockhardt Usa Inc.. Units affected: 93,393 bottles.
Why was this product recalled?
Failed Tablet/Capsule Specifications: out of specification for thickness.
Which agency issued this recall?
This recall was issued by the FDA Drug on May 13, 2015. Severity: Moderate. Recall number: D-0975-2015.