Why it was recalled
CGMP Deviations: Firm did not adequately investigate customer complaints.
Product description
Extended Phenytoin Sodium Capsules, USP, 100 mg Capsules, Packaged as A) 100 Count Bottles (NDC: 64679-720-01) and B) 1000 Count Bottles (NDC: 64679-720-02), 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 #: DM11488, Expiry: 4/30/2015; Lot #: DM12093, Expiry: 6/30/2015; Lot #: DM12540, Expiry: 7/31/2015. B) Lot #: DM11412, Expiry: 4/30/2015; Lot #: DM11642, Expiry: 5/31/2015; Lot #: DM11682, Expiry: 5/31/2015; Lot #: DM12094, Expiry: 6/30/2015; Lot #: DM12533, Expiry: 7/31/2015; Lot #: DM12609, Expiry: 7/31/2015; Lot #: DM12898, Expiry: 9/30/2015, Lot #: DM12899, Expiry: 9/30/2015; Lot #: DN10163, Expiry: 11/30/2015; Lot #: DN10273, Expiry: 11/30/2015; Lot #: DN10487, Expiry: 12/31/2015.
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-1246-2015
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Apr 22, 2015
- FDA report date
- Jul 29, 2015
- Quantity
- 53,894 Bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Wockhardt Usa Inc.
Original FDA data
Every field from FDA enforcement report D-1246-2015, 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 #: DM11488, Expiry: 4/30/2015; Lot #: DM12093, Expiry: 6/30/2015; Lot #: DM12540, Expiry: 7/31/2015. B) Lot #: DM11412, Expiry: 4/30/2015; Lot #: DM11642, Expiry: 5/31/2015; Lot #: DM11682, Expiry: 5/31/2015; Lot #: DM12094, Expiry: 6/30/2015; Lot #: DM12533, Expiry: 7/31/2015; Lot #: DM12609, Expiry: 7/31/2015; Lot #: DM12898, Expiry: 9/30/2015, Lot #: DM12899, Expiry: 9/30/2015; Lot #: DN10163, Expiry: 11/30/2015; Lot #: DN10273, Expiry: 11/30/2015; Lot #: DN10487, Expiry: 12/31/2015.
- Postal code
- 07054-1271
- Report date
- Jul 29, 2015
- Product type
- Drugs
- Recall number
- D-1246-2015
- Classification
- Class II
- Recalling firm
- Wockhardt Usa Inc.
- Product quantity
- 53,894 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
- Extended Phenytoin Sodium Capsules, USP, 100 mg Capsules, Packaged as A) 100 Count Bottles (NDC: 64679-720-01) and B) 1000 Count Bottles (NDC: 64679-720-02), 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