Recalls / Class II
Class IID-1120-2019
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
- Brand name
- Pravastatin Sodium
- Generic name
- Pravastatin Sodium
- Active ingredient
- Pravastatin Sodium
- Route
- Oral
- NDCs
- 68462-195, 68462-196, 68462-197, 68462-198
- FDA application
- ANDA077987
- Affected lot / code info
- Lot 17181491 Exp. Aug. 2021
Why it was recalled
Presence Of Foreign Tablet: in a bottle of Pravastatin Sodium Tablets 20 mg.
Recalling firm
- Firm
- Glenmark Pharmaceuticals Inc., USA
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 750 Corporate Dr, N/A, Mahwah, New Jersey 07430-2009
Distribution
- Quantity
- 2076 500-count Bottles
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2019-03-25
- FDA classified
- 2019-04-11
- Posted by FDA
- 2019-04-17
- Terminated
- 2020-09-14
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1120-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.