Recalls / Class II
Class IID-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
- Affected lot / code info
- Lot #s: a) LM10525, Exp 03/15; LM10727, Exp 04/15; LM11519, Exp 08/15; LN10008, Exp 11/15; LN10121, Exp 12/15; LN10887, Exp 04/16; LM11248, Exp 06/16 Lot #s: b) LM10522, Exp 03/15; LM10726, Exp 04/15; LN10007, Exp 11/15; LN10116, Exp 12/15; LN10888, Exp 04/16; LN11281 Exp 07/16
Why it was recalled
Failed Tablet/Capsule Specifications: out of specification for thickness.
Recalling firm
- Firm
- Wockhardt Usa Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 20 Waterview Blvd Ste 3, N/A, Parsippany, New Jersey 07054-1271
Distribution
- Quantity
- 93,393 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2015-03-12
- FDA classified
- 2015-05-01
- Posted by FDA
- 2015-05-13
- Terminated
- 2017-12-14
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0975-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.