February 2023 FDA Recall Gabapentin by Sciegen Pharmaceuticals Inc
D-0354-2023 - Presence of Foreign Tablets/Capsules
This Class III drug recall was voluntarily initiated by Sciegen Pharmaceuticals Inc on February 17, 2023 for the product Gabapentin. The FDA reported the reason for recall as presence of foreign tablets/capsules. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: 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.
02-17-2023
03-08-2023
4,392 bottles
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Sciegen Pharmaceuticals Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide in the USA and Puerto Rico
06-17-2024
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Gabapentin Tablets, USP 600 mg, 500 tablets per bottle, RX Only, Manufactured by ScieGen Pharmaceuticals Inc., Hauppauge, NY 11788, NDC: 50228-177-05.
Batch or Lot Expiration Information
Lot# G177092, Exp. 11/24
