Drug 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
D-0975-2015
Product summary
- Event
- Event 70740
- Status
- Terminated
- Classification
- Class II
- Quantity
- 93,393 bottles
- Official record key
drug-enforcement:D-0975-2015
Official wording
Reason: Failed Tablet/Capsule Specifications: out of specification for thickness.
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
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
out of specification