FDAClass IIIMay 27, 2020

Gabapentin Tablets USP recall: Impurity Out of Spec

Gabapentin Tablets USP, 600 mg, Rx Only, 500-count bottle, Manufactured for: Exelan Pharmaceuticals, Inc., Lawrenceville, GA 30046, Manufactured by…

Why was Gabapentin Tablets USP recalled?

Failed Impurities/Degradation Specifications; failure of Impurity A test at the 12-month long-term stability testing.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot # NB900413, Exp. 12/2020

Product
Gabapentin Tablets USP, 600 mg, Rx Only, 500-count bottle, Manufactured for: Exelan Pharmaceuticals, Inc., Lawrenceville, GA 30046, Manufactured by…
Recalling firm
InvaGen Pharmaceuticals, Inc.
Quantity
2,202 bottles
Distribution
Nationwide in the U.S.
Recall date
May 27, 2020
Classification
Class III
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls