Recalls / Class II
Class IID-0612-2024
Product
Pravastatin Sodium Tablets, USP 80mg, packaged in a) 90-count bottle, NDC 68462-198-90; b) 500-count bottle, NDC 68462-198-05, Rx only, Manufactured by: Glenmark Pharmaceuticals Limited Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430,
- 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#: a) 17211249, 17211264, 17211266,17211286, Exp 6/30/24; 17211525, 17211535, 17211549, Exp 7/31/24; 17211787, 17211801, 8/31/24; 17212041, 9/30/24; 17212088, 17212106, Exp 10/31/24; 17212346, 17212345, 11/30/24; 17220053, 17220054, 17220055 12/31/24; 17220309, 17220310, Exp 1/31/25; b) 17211290, 6/30/2024
Why it was recalled
Failed Dissolution Specifications: results below specifications
Recalling firm
- Firm
- Glenmark Pharmaceuticals Inc., USA
- Type
- Voluntary: Firm initiated
- Address
- 750 Corporate Dr, Mahwah, New Jersey 07430-2009
Distribution
- Quantity
- a) 145,800 bottles; b) 1,368 bottles
- Distribution pattern
- USA Nationwide
Timeline
- Recall initiated
- 2024-06-28
- FDA classified
- 2024-07-18
- Posted by FDA
- 2024-07-24
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0612-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.