Drug product
Gabapentin Tablets, USP, 800 mg, 500-count, Rx only, Made in India, PONDRUGS/16 134193, Distributed by: Solco Healthcare US, LLC, Cranbury, NJ, 08512, USA. NDC 43547-0333-50
D-0155-2018
Product summary
- Event
- Event 78697
- Status
- Terminated
- Classification
- Class II
- Quantity
- N/A
- Official record key
drug-enforcement:D-0155-2018
Official wording
Reason: Labeling: Label Mix-Up.some bottles labeled as Gabapentin 800 mg contain Gabapentin 600 mg
Code information: Lot # 7700656A
Distribution pattern: Product was distributed in Mason, OH.
Derived failure modes
-
Labeling or packaging
Labeling: Label Mix-Up