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Recall Observatory FDA recall evidence

Drug 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,

D-0612-2024

June 28, 2024

Class II

Product summary

Firm
Glenmark Pharmaceuticals Inc., USA
Event
Event 94899
Status
Ongoing
Classification
Class II
Quantity
a) 145,800 bottles; b) 1,368 bottles
Official record key
drug-enforcement:D-0612-2024

Official wording

Reason: Failed Dissolution Specifications: results below specifications

Code information: 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

Distribution pattern: USA Nationwide

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Failed Dissolution Specifications