FDA Recall D-0612-2024

Glenmark Pharmaceuticals Inc., USA · Mahwah, NJ

Class II Ongoing 685 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

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,

Lot / code: 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

Quantity: a) 145,800 bottles; b) 1,368 bottles

Reason for recall

Failed Dissolution Specifications: results below specifications

Recall record

Recall number: D-0612-2024
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Distribution: USA Nationwide
Recall initiated: 2024-06-28
Classified by FDA Center: 2024-07-18
FDA published: 2024-07-24
Recalling firm: Glenmark Pharmaceuticals Inc., USA
Firm location: Mahwah, NJ

Drug identification

Brand name(s): PRAVASTATIN SODIUM
Generic name(s): PRAVASTATIN SODIUM
Manufacturer(s): Glenmark Pharmaceuticals Inc., USA
NDC(s): 68462-195, 68462-196, 68462-197, 68462-198
Route(s): ORAL

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

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