Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Labeling: Label Mixup: GABAPENTIN, Tablet, 600 mg may have potentially been mislabeled as the following drug: ARIPiprazole, Tablet, 15 mg, NDC 59148000913, Pedigree: AD21965_1, EXP: 5/1/2014.
GABAPENTIN, Tablet, 600 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00228263611.
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Reason Failed Impurities/Degradation Specifications: an out of specification result obtained during routine stability testing for Highest Unknown Impurity .
Reason Failed Impurities/Degradation Specifications: an out of specification result obtained during routine stability testing for Highest Unknown Impurity .
Reason Defective container; blister packaging inadequately sealed.
Reason Defective container; blister packaging inadequately sealed.
Reason CGMP Deviations
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