Gabapentin Oral Solution
Failed Impurities/Degradation Specifications; out of specification for unknown impurity observed during 6 month stability testing
National Drug Code
Gabapentin Oral Solution
1 FDA recall names the code 50383-0311-07 directly. A recall still applies to particular lot numbers — compare the lot on your package with the FDA notice below, and talk to your pharmacist before stopping a prescribed medication.
This code is not in the current FDA NDC directory — usual for a product that has since been discontinued or repackaged. The details below come from the recall notices themselves.
Failed Impurities/Degradation Specifications; out of specification for unknown impurity observed during 6 month stability testing
CGMP Deviations: Inadvertent release of a drug product with unapproved active ingredient manufacturer.
Where to find this code. The NDC is printed on the pharmacy label and on the manufacturer's carton, usually as three groups of digits after “NDC”. The last group is the package size — two bottles of the same medicine can differ only in that group, and a recall may cover one but not the other.
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