Drug product
Pravastatin Sodium Tablets, USP, 20 mg, 30-count bottles, packaged in 12 x 30 tablets for individual patient dispensing per pharmacy dispenser carton, Rx only, Packaged for: International Laboratories, LLC. St. Petersburg, FL 33710, NDC 54458-926-16.
D-0234-2018
Product summary
- Event
- Event 78939
- Status
- Terminated
- Classification
- Class II
- Quantity
- 13,403 cartons
- Official record key
drug-enforcement:D-0234-2018
Official wording
Reason: Presence of Foreign Tablets/Capsules: bottles could contain both pravastatin sodium 10 mg and 20 mg tablets in the same bottle.
Code information: Lot: 117103A, Exp. 03/19
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Foreign material or chemical contamination
Foreign Tablets