InvaGen Pharmaceuticals, Inc. has voluntarily recalled 2,202 bottles of Gabapentin (Neurontin), a medication used to treat seizures and nerve pain, because the product failed a long-term stability test for a specific impurity. Specifically, the tablets exceeded the allowed limit for 'Impurity A' after 12 months of testing, which means the drug's quality and chemical composition may have degraded over time. The recall affects 500-count bottles of Gabapentin 600 mg tablets distributed nationwide under the Exelan Pharmaceuticals label. Consumers who have this medication should contact their doctor or pharmacist to discuss their treatment and obtain a safe replacement.
The failure of the stability test indicates that the medication may contain higher-than-permitted levels of degradation products (impurities) as it ages. This could potentially reduce the effectiveness of the medication or introduce unknown health risks from the chemical impurities themselves.
Drug recall stability failure remedy
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Sources: FDA iRES · Raw API Response
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