Recalls / Class II
Class IID-1515-2019
Product
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
- Affected lot / code info
- a) Lot# 19140443, exp. date 12/2020, Lot# 19140525, 19140535, exp. date 01/2021 and b) Lot# 19140756, exp. date 12/2020, Lot# 19140757, Lot# 19140758, exp. date 01/2021, Lot# 19141696, Lot# 19141793, exp. date 03/2021
Why it was recalled
Failed Dissolution Specifications
Recalling firm
- Firm
- Ascend Laboratories LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 339 Jefferson Rd Ste 101, N/A, Parsippany, New Jersey 07054-3707
Distribution
- Quantity
- a) 5,472 bottles and b) 5,880 bottles
- Distribution pattern
- Product was shipped to wholesalers throughout the United States.
Timeline
- Recall initiated
- 2019-07-19
- FDA classified
- 2019-07-24
- Posted by FDA
- 2019-07-31
- Terminated
- 2021-06-07
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1515-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.