Status
Terminated
Drug Enforcement D-0354-2023
Presence of Foreign Tablets/Capsules: Pharmacist reported presence of some Gabapentin tablets 800 mg comingled in Gabapentin 600 mg 500 count bottles.
Classification
Class III
Report Date
March 8, 2023
Termination Date
June 17, 2024
Product Information
- 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.
- Product quantity
- 4,392 bottles
- 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.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide in the USA and Puerto Rico
Location & Firm
- Recalling firm
- Sciegen Pharmaceuticals Inc
- Address
-
89 Arkay Dr, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0354-2023
- Event ID
- 91717
- Recall initiation date
- February 17, 2023
- Center classification date
- February 27, 2023
- Code info
- Lot # G177092, Exp. 11/24
- More code info
- —