Home / Recalls / Wockhardt Usa Inc. / D-1267-2015

D-1267-2015 Class II Terminated

Recalled by Wockhardt Usa Inc. — Parsippany, NJ

FDA drug recall D-1267-2015 was initiated by Wockhardt Usa Inc. on Apr 22, 2015 and is designated Class II. Reason for recall: CGMP Deviations: Firm did not adequately investigate customer complaints. The recall status is terminated (terminated May 9, 2018). Affected quantity: 1,002 Drums.

Recall details

Product Type: Drugs
Report Date: Jul 29, 2015
Initiation Date: Apr 22, 2015
Termination Date: May 9, 2018
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 1,002 Drums

Product description

Famotodine Tablets, USP, 10 mg Tablets, For Repacking Only, Packaged in 50,000 Count Drums, Over the Counter. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. NDC: 64679-0972-00.

Reason for recall

CGMP Deviations: Firm did not adequately investigate customer complaints.

Distribution pattern

U.S. Nationwide including Puerto Rico.

Code information

Lot #: LM10826, Expiry: 5/31/2015; Lot #: LM10999, Expiry: 5/31/2015; Lot #: LM11016, Expiry: 6/30/2015; Lot #: LM11032, Expiry: 6/30/2015; Lot #: LM11038, Expiry: 6/30/2015; Lot #: LM11087, Expiry: 6/30/2015; Lot #: LM11149, Expiry: 4/30/2015; Lot #: LM11156, Expiry: 4/30/2015; Lot #: LM11615, Expiry: 8/31/2015; Lot #: LN10195, Expiry: 12/31/2015; Lot #: LN10323, Expiry: 12/31/2015; Lot #: LN10500, Expiry: 1/31/2016; Lot #: LN10507, Expiry: 1/31/2016; Lot #: LN10514, Expiry: 2/29/2016; Lot #: LN10555, Expiry: 2/29/2016; Lot #: LN10556, Expiry: 2/29/2016; Lot #: LN10565, Expiry: 2/29/2016; Lot #: LN10784, Expiry: 3/31/2016; Lot #: LN10788, Expiry: 3/31/2016; Lot #: LN10831, Expiry: 3/31/2016; Lot #: LN10839, Expiry: 3/31/2016; Lot #: LN10846, Expiry: 3/31/2016; Lot #: LN10856, Expiry: 3/31/2016; Lot #: LN10884, Expiry: 3/31/2016; Lot #: LN10916, Expiry: 4/30/2016; Lot #: LN10931, Expiry: 4/30/2016; Lot #: LN10934, Expiry: 4/30/2016; Lot #: LN11067, Expiry: 5/31/2016; Lot #: LN11072, Expiry: 5/31/2016.

Source

Dataset: openFDA drug recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for D-1267-2015
openFDA file date: Nov 10, 2026
Loaded by RegDataLab: Nov 11, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

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