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.
Reported: May 27, 2020 Initiated: May 14, 2020 #D-1272-2020
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.
Details
- Recalling Firm
- InvaGen Pharmaceuticals, Inc.
- Units Affected
- 2,202 bottles
- Distribution
- Nationwide in the U.S.
- Location
- Hauppauge, NY
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by InvaGen Pharmaceuticals, Inc.. Units affected: 2,202 bottles.
Why was this product recalled? ▼
Failed Impurities/Degradation Specifications; failure of Impurity A test at the 12-month long-term stability testing.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on May 27, 2020. Severity: Low. Recall number: D-1272-2020.
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