Class III
Terminated
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.
- Company
- Invagen Pharmaceuticals, Inc.
- Recall Initiated
- May 14, 2020
- Posted
- May 27, 2020
- Recall Number
- D-1272-2020
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 2,202 bottles
- Firm Location
- Hauppauge, NY, United States
Reason for Recall
Failed Impurities/Degradation Specifications; failure of Impurity A test at the 12-month long-term stability testing.
Distribution
Nationwide in the U.S.
Lot / Code Info
Lot # NB900413, Exp. 12/2020
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