Why it was recalled
CGMP Deviations: Firm did not adequately investigate customer complaints.
Product description
Famotodine Tablets, USP, 40 mg Tablets, Packaged in A) 30 Count Bottles (NDC: 64679-937-01), B) 100 Count Bottles (NDC: 64679-937-02), and C) 1000 Count Bottles (NDC: 64679-937-03), Rx only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA.
Lot numbers, UPCs & expiration codes
A) Lot #: LM10806, Expiry: 5/31/2015; Lot #: LM11099, Expiry: 6/30/2015; Lot #: LM11297, Expiry: 7/31/2015; Lot #: LM11933, Expiry: 10/31/2015; Lot #: LN10180, Expiry: 12/31/2015; Lot #: LN10547, Expiry: 2/29/2016. B) Lot #: LM10784, Expiry: 5/31/2015; Lot #: LM10791, Expiry: 5/31/2015; Lot #: LM10812, Expiry: 5/31/2015; Lot #: LM11112, Expiry: 6/30/2015; Lot #: LM11298, Expiry: 7/31/2015; Lot #: LM11299, Expiry: 7/31/2015; Lot #: LM11625, Expiry: 8/31/2015; Lot #: LN10182, Expiry: 12/31/2015; Lot #: LN10548, Expiry: 2/29/2016; Lot #: LN11115, Expiry: 5/31/2016; Lot #: LN11367, Expiry: 8/31/2016; Lot #: LN11369, Expiry: 8/31/2016. C) Lot #: LM10813, Expiry: 5/31/2015; Lot #: LM11085, Expiry: 6/30/2015; Lot #: LM11088, Expiry: 6/30/2015; Lot #: LM11296, Expiry: 7/31/2015; Lot #: LM11932, Expiry: 10/31/2015; Lot #: LN10181, Expiry: 12/31/2015; Lot #: LN10549, Expiry: 2/29/2016; Lot #: LN11114, Expiry: 5/31/2016; Lot #: LN11359, Expiry: 8/31/2016.
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-1250-2015
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Apr 22, 2015
- FDA report date
- Jul 29, 2015
- Quantity
- A) 70,428 Bottles, B) 128,420 Bottles, and C) 8,101 Bottles.
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Wockhardt Usa Inc.
Original FDA data
Every field from FDA enforcement report D-1250-2015, 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
- A) Lot #: LM10806, Expiry: 5/31/2015; Lot #: LM11099, Expiry: 6/30/2015; Lot #: LM11297, Expiry: 7/31/2015; Lot #: LM11933, Expiry: 10/31/2015; Lot #: LN10180, Expiry: 12/31/2015; Lot #: LN10547, Expiry: 2/29/2016. B) Lot #: LM10784, Expiry: 5/31/2015; Lot #: LM10791, Expiry: 5/31/2015; Lot #: LM10812, Expiry: 5/31/2015; Lot #: LM11112, Expiry: 6/30/2015; Lot #: LM11298, Expiry: 7/31/2015; Lot #: LM11299, Expiry: 7/31/2015; Lot #: LM11625, Expiry: 8/31/2015; Lot #: LN10182, Expiry: 12/31/2015; Lot #: LN10548, Expiry: 2/29/2016; Lot #: LN11115, Expiry: 5/31/2016; Lot #: LN11367, Expiry: 8/31/2016; Lot #: LN11369, Expiry: 8/31/2016. C) Lot #: LM10813, Expiry: 5/31/2015; Lot #: LM11085, Expiry: 6/30/2015; Lot #: LM11088, Expiry: 6/30/2015; Lot #: LM11296, Expiry: 7/31/2015; Lot #: LM11932, Expiry: 10/31/2015; Lot #: LN10181, Expiry: 12/31/2015; Lot #: LN10549, Expiry: 2/29/2016; Lot #: LN11114, Expiry: 5/31/2016; Lot #: LN11359, Expiry: 8/31/2016.
- Postal code
- 07054-1271
- Report date
- Jul 29, 2015
- Product type
- Drugs
- Recall number
- D-1250-2015
- Classification
- Class II
- Recalling firm
- Wockhardt Usa Inc.
- Product quantity
- A) 70,428 Bottles, B) 128,420 Bottles, and C) 8,101 Bottles.
- 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, 40 mg Tablets, Packaged in A) 30 Count Bottles (NDC: 64679-937-01), B) 100 Count Bottles (NDC: 64679-937-02), and C) 1000 Count Bottles (NDC: 64679-937-03), Rx only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA.
- Distribution pattern
- U.S. Nationwide including Puerto Rico.
- Recall initiation date
- Apr 22, 2015
- Initial firm notification
- Letter
- Center classification date
- Jul 17, 2015