Class II
Ongoing
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,
This recall is currently active, issued July 24, 2024. It was issued by Glenmark Pharmaceuticals Inc., Usa.
- Recall Initiated
- June 28, 2024
- Posted
- July 24, 2024
- Recall Number
- D-0612-2024
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- a) 145,800 bottles; b) 1,368 bottles
- Firm Location
- Mahwah, NJ, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Failed Dissolution Specifications: results below specifications
Distribution
USA Nationwide
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
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