InvaGen Recalls Gabapentin Tablets Due to Impurity Test Failure
InvaGen Pharmaceuticals is recalling 2,202 bottles of Gabapentin 600 mg tablets because they failed an impurity test during stability testing.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classified this as a Class III recall, which by definition is unlikely to cause adverse health consequences, aligning with the 'Low' severity criterion for documentation or minor specification issues.
Plain-English summary
InvaGen Pharmaceuticals, Inc. is recalling 2,202 bottles of Gabapentin Tablets USP, 600 mg, 500-count. The product is manufactured for Exelan Pharmaceuticals, Inc. and was distributed nationwide in the U.S. The specific lot number is NB900413, with an expiration date of 12/2020.
The recall was initiated because the product failed the Impurity A test at the 12-month long-term stability testing. This constitutes a failure of impurities/degradation specifications.
Consumers should stop using the recalled product and contact their healthcare provider or pharmacist for guidance on obtaining a replacement or alternative medication.
The recalled product
- Product
- GABAPENTIN (GABAPENTIN)
- Brand
- GABAPENTIN
- Manufacturer
- InvaGen Pharmaceuticals, Inc.
- Category
- Drug — Prescription Drug
- Hazard
- Affected units
- 2,202
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot # NB900413
- Exp. 12/2020
UPCs (2)
- 0376282405902
- 0376282406909
Distribution
Distributed nationwide across the United States.
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