FDA Drug Class II — Moderate

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

Hazard

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

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Products

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
Brand
Wockhardt Usa Inc.
UPC
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

Units Affected

93,393 bottles

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