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.
Hazard
CGMP Deviations: Firm did not adequately investigate customer complaints.
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Products
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 W
- Brand
- Wockhardt Usa Inc.
- UPC
- 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.
Units Affected
1,002 Drums