Why it was recalled
CGMP Deviations: Firm did not adequately investigate customer complaints.
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.
Lot numbers, UPCs & expiration codes
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.
Where it was sold
U.S. Nationwide including Puerto Rico.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1267-2015
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Apr 22, 2015
- FDA report date
- Jul 29, 2015
- Quantity
- 1,002 Drums
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Wockhardt Usa Inc.
Original FDA data
Every field from FDA enforcement report D-1267-2015, exactly as published.
Show all FDA fields
- City
- Parsippany
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 71104
- Address
- 20 Waterview Blvd Ste 3
- 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.
- Postal code
- 07054-1271
- Report date
- Jul 29, 2015
- Product type
- Drugs
- Recall number
- D-1267-2015
- Classification
- Class II
- Recalling firm
- Wockhardt Usa Inc.
- Product quantity
- 1,002 Drums
- Termination date
- May 9, 2018
- Reason for recall
- CGMP Deviations: Firm did not adequately investigate customer complaints.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Distribution pattern
- U.S. Nationwide including Puerto Rico.
- Recall initiation date
- Apr 22, 2015
- Initial firm notification
- Letter
- Center classification date
- Jul 17, 2015