Glenmark Pharmaceuticals Inc., USA: 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 Ph

Hazard

Failed Dissolution Specifications: results below specifications

Details from the source

Reason for recall: Failed Dissolution Specifications: results below specifications Distribution: USA Nationwide Quantity: a) 145,800 bottles; b) 1,368 bottles 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

Source

Official record: FDA (Drug enforcement) ↗

Republished from the official source above; details can change — the source record controls.