Why it was recalled
Presence of Foreign Tablets/Capsules: Pharmacist reported presence of some Gabapentin tablets 800 mg comingled in Gabapentin 600 mg 500 count bottles.
Product description
Gabapentin Tablets, USP 600 mg, 500 tablets per bottle, RX Only, Manufactured by ScieGen Pharmaceuticals Inc., Hauppauge, NY 11788, NDC: 50228-177-05.
Lot numbers, UPCs & expiration codes
Lot # G177092, Exp. 11/24
Where it was sold
Nationwide in the USA and 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-0354-2023
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Feb 17, 2023
- FDA report date
- Mar 8, 2023
- Quantity
- 4,392 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Sciegen Pharmaceuticals Inc
Original FDA data
Every field from FDA enforcement report D-0354-2023, exactly as published.
Show all FDA fields
- City
- Hauppauge
- State
- NY
- Status
- Terminated
- Country
- United States
- Event ID
- 91717
- Address
- 89 Arkay Dr
- Code information
- Lot # G177092, Exp. 11/24
- Postal code
- 11788-3727
- Report date
- Mar 8, 2023
- Product type
- Drugs
- Recall number
- D-0354-2023
- Classification
- Class III
- Recalling firm
- Sciegen Pharmaceuticals Inc
- Product quantity
- 4,392 bottles
- Termination date
- Jun 17, 2024
- Reason for recall
- Presence of Foreign Tablets/Capsules: Pharmacist reported presence of some Gabapentin tablets 800 mg comingled in Gabapentin 600 mg 500 count bottles.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Gabapentin Tablets, USP 600 mg, 500 tablets per bottle, RX Only, Manufactured by ScieGen Pharmaceuticals Inc., Hauppauge, NY 11788, NDC: 50228-177-05.
- Distribution pattern
- Nationwide in the USA and Puerto Rico
- Recall initiation date
- Feb 17, 2023
- Initial firm notification
- Letter
- Center classification date
- Feb 27, 2023