Drug product
Pravastatin Sodium Tablets USP, 20 mg, 500-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd. Plot No. 2, Phase-2, Pharma zone SEZ, Pithampur, Dist-Dhar, Madhya Pradesh 454 775, India. Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430. NDC 68462-196-05
D-1120-2019
Product summary
- Event
- Event 82461
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2076 500-count Bottles
- Official record key
drug-enforcement:D-1120-2019
Official wording
Reason: Presence Of Foreign Tablet: in a bottle of Pravastatin Sodium Tablets 20 mg.
Code information: Lot 17181491 Exp. Aug. 2021
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Foreign material or chemical contamination
Foreign Tablet