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

FDA recall notice · announced May 13, 2015 · Wockhardt

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The 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.

Notes

Distribution: Nationwide
Lot/code information: 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
Quantity: 93,393 bottles
Status: Terminated
Products in this recall event:
- 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 (D-0975-2015)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.