Class II
Terminated
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
This recall has been terminated (originally issued July 31, 2019).
- Company
- Ascend Laboratories, Llc
- Recall Initiated
- July 19, 2019
- Posted
- July 31, 2019
- Recall Number
- D-1515-2019
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- a) 5,472 bottles and b) 5,880 bottles
- Firm Location
- Parsippany, NJ, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Failed Dissolution Specifications
Distribution
Product was shipped to wholesalers throughout the United States.
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
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