Atorvastatin Calcium Tablet USP 80 mg, a) 90 count (NDC 67877-0514-90) and b) 500 count (NDC 67877-0514-05) bottles, Rx only, Manufactured by: Alkem Laboratories, Ltd, Mumbai INDIA, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ
Reported: July 31, 2019 Initiated: July 19, 2019 #D-1515-2019
Product Description
Atorvastatin Calcium Tablet USP 80 mg, a) 90 count (NDC 67877-0514-90) and b) 500 count (NDC 67877-0514-05) bottles, Rx only, Manufactured by: Alkem Laboratories, Ltd, Mumbai INDIA, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ
Reason for Recall
Failed Dissolution Specifications
Details
- Recalling Firm
- Ascend Laboratories LLC
- Units Affected
- a) 5,472 bottles and b) 5,880 bottles
- Distribution
- Product was shipped to wholesalers throughout the United States.
- Location
- Parsippany, NJ
Frequently Asked Questions
What product was recalled? ▼
Atorvastatin Calcium Tablet USP 80 mg, a) 90 count (NDC 67877-0514-90) and b) 500 count (NDC 67877-0514-05) bottles, Rx only, Manufactured by: Alkem Laboratories, Ltd, Mumbai INDIA, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ. Recalled by Ascend Laboratories LLC. Units affected: a) 5,472 bottles and b) 5,880 bottles.
Why was this product recalled? ▼
Failed Dissolution Specifications
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on July 31, 2019. Severity: Moderate. Recall number: D-1515-2019.
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