D-1272-2020 Class III Terminated
FDA drug recall D-1272-2020 was initiated by InvaGen Pharmaceuticals, Inc. on May 14, 2020 and is designated Class III. Reason for recall: Failed Impurities/Degradation Specifications; failure of Impurity A test at the 12-month long-term stability testing. The recall status is terminated (terminated August 31, 2020). Affected quantity: 2,202 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- May 27, 2020
- Initiation Date
- May 14, 2020
- Termination Date
- August 31, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2,202 bottles
Product Description
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.
Reason for Recall
Failed Impurities/Degradation Specifications; failure of Impurity A test at the 12-month long-term stability testing.
Distribution Pattern
Nationwide in the U.S.
Code Information
Lot # NB900413, Exp. 12/2020