Recall D-0612-2024

US Class II Ongoing · initiated 2024-06-28

Recalling firm

Glenmark Pharmaceuticals Inc., USA, NJ

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,

Reason for recall

Failed Dissolution Specifications: results below specifications

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