D-1515-2019 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- July 31, 2019
- Initiation Date
- July 19, 2019
- Termination Date
- June 7, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- a) 5,472 bottles and b) 5,880 bottles
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
Distribution Pattern
Product was shipped to wholesalers throughout the United States.
Code Information
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