D-0354-2023 Class III Terminated
FDA drug recall D-0354-2023 was initiated by Sciegen Pharmaceuticals Inc on February 17, 2023 and is designated Class III. 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. The recall status is terminated (terminated June 17, 2024). Affected quantity: 4,392 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- March 8, 2023
- Initiation Date
- February 17, 2023
- Termination Date
- June 17, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4,392 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.
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.
Distribution Pattern
Nationwide in the USA and Puerto Rico
Code Information
Lot # G177092, Exp. 11/24