Why it was recalled
Defective Container: powder may leak out of the pouch
Product description
Vigabatrin for Oral Solution, USP 500 mg per packet, 50 packets per box, Rx Only, Manufactured by: InvaGen Pharmaceuticals, Inc., (a subsidiary of Cipla Ltd.), Hauppauge, NY, 11788, Manufactured for: Cipla USA, Inc., Warren, NJ 07059, NDC 69097-964-53
Lot numbers, UPCs & expiration codes
Lot #: NB301030, Exp. Date 03/31/2025
Where it was sold
Nationwide within the United States
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-0220-2024
- Classification
- Class I
- Status
- Completed
- Recall initiated
- Nov 17, 2023
- FDA report date
- Jan 17, 2024
- Quantity
- 1240 boxes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- InvaGen Pharmaceuticals, Inc.
Original FDA data
Every field from FDA enforcement report D-0220-2024, exactly as published.
Show all FDA fields
- City
- Central Islip
- State
- NY
- Status
- Completed
- Country
- United States
- Event ID
- 93422
- Address
- 550 S Research Pl
- Code information
- Lot #: NB301030, Exp. Date 03/31/2025
- Postal code
- 11722-4415
- Report date
- Jan 17, 2024
- Product type
- Drugs
- Recall number
- D-0220-2024
- Classification
- Class I
- Recalling firm
- InvaGen Pharmaceuticals, Inc.
- Product quantity
- 1240 boxes
- Reason for recall
- Defective Container: powder may leak out of the pouch
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Vigabatrin for Oral Solution, USP 500 mg per packet, 50 packets per box, Rx Only, Manufactured by: InvaGen Pharmaceuticals, Inc., (a subsidiary of Cipla Ltd.), Hauppauge, NY, 11788, Manufactured for: Cipla USA, Inc., Warren, NJ 07059, NDC 69097-964-53
- Distribution pattern
- Nationwide within the United States
- Recall initiation date
- Nov 17, 2023
- Initial firm notification
- Letter
- Center classification date
- Jan 8, 2024