Atorvastatin Calcium Tablets USP, 80 mg, Rx Only, a). 90-count(NDC 67877-514-90), b). 500-count(NDC 67877-514-05), Manufactured by: Alkem Laboratories, Ltd. India, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054
Reported: October 22, 2025 Initiated: September 19, 2025 #D-0020-2026
Product Description
Atorvastatin Calcium Tablets USP, 80 mg, Rx Only, a). 90-count(NDC 67877-514-90), b). 500-count(NDC 67877-514-05), Manufactured by: Alkem Laboratories, Ltd. India, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054
Reason for Recall
Failed Dissolution Specifications
Details
- Recalling Firm
- Ascend Laboratories, LLC
- Distribution
- U.S. Nationwide
- Location
- Bedminster, NJ
Frequently Asked Questions
What product was recalled? ▼
Atorvastatin Calcium Tablets USP, 80 mg, Rx Only, a). 90-count(NDC 67877-514-90), b). 500-count(NDC 67877-514-05), Manufactured by: Alkem Laboratories, Ltd. India, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054. Recalled by Ascend Laboratories, LLC.
Why was this product recalled? ▼
Failed Dissolution Specifications
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on October 22, 2025. Severity: Moderate. Recall number: D-0020-2026.
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