May 2020 FDA Recall Gabapentin by Invagen Pharmaceuticals, Inc.
D-1272-2020 - Failed Impurities/Degradation Specifications; failure of Impurity A test at the 12-month long-term stability testing.
This Class III drug recall was voluntarily initiated by Invagen Pharmaceuticals, Inc. on May 14, 2020 for the product Gabapentin. The FDA reported the reason for recall as failed impurities/degradation specifications; failure of impurity a test at the 12-month long-term stability testing.. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-1272-2020
Failed Impurities/Degradation Specifications; failure of Impurity A test at the 12-month long-term stability testing.
05-14-2020
05-27-2020
2,202 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.
InvaGen 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 U.S.
08-31-2020
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Gabapentin Tablets USP, 600 mg, Rx Only, 500-count bottle, Manufactured for: Exelan Pharmaceuticals, Inc., Lawrenceville, GA 30046, Manufactured by: InvaGen Pharmaceuticals, Inc., Hauppauge, NY 11788, NDC 76282-405-05.
Batch or Lot Expiration Information
Lot# NB900413, Exp. 12/2020
