Ascend Laboratories recalls Alkem Atorvastatin Calcium Tablets USP 20 mg for dissolution failures in 2025. Distributed by Ascend Laboratories, Parsippany, NJ, nationwide. The issue: dissolution specifications not met. Stop use immediately and follow recall instructions. Check your NDC numbers to identify affected lots.
Failed Dissolution Specifications
Consumers and healthcare providers should stop using this product immediately. Contact Ascend Laboratories, LLC or your healthcare provider for guidance. Notification method: Letter
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Atorvastatin calcium tablets are prescribed to lower cholesterol and reduce cardiovascular risk. The recalled lots were distributed nationwide in the United States.
Dissolution failure can lead to inconsistent absorption, potentially reducing efficacy and impacting lipid control.
This recall is not described as part of a broader industry pattern.
Patients may experience subtherapeutic dosing which could affect cholesterol management and cardiovascular risk.
NDC codes on the bottle label and packaging; recall notification letters to healthcare facilities
Recall notifications may lead to refunds or replacements; processing times vary
Retain recall notices, packaging, prescription records, and correspondence with the manufacturer
Product: Atorvastatin Calcium Tablets USP, 20 mg, Rx Only. 90-count NDC 67877-512-90; 500-count NDC 67877-512-05; 1000-count NDC 67877-512-10. Manufactured by: Alkem Laboratories, Ltd. India. Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054. Sold nationwide in the U.S.
No injuries or incidents have been reported.
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