Reported Jul 31, 2019 · Terminated
Atorvastatin Calcium Tablet USP 80 mg, a) 90 count (NDC 67877-0514-90) and b) 500 count (NDC 67877-0514-05) bottles, Rx…
Ascend Laboratories LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Ascend Laboratories LLC · 339 Jefferson Rd Ste 101 · Parsippany, NJ · 07054-3707
Is this the product you have?
- 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 byAlkem Laboratories, Ltd, Mumbai INDIA
- Distributed byAscend Laboratories, LLC, Parsippany, NJ
- Lot codes and dates
a) Lot# 19140443exp. date 12/2020Lot# 1914052519140535exp. date 01/2021 and b) Lot# 19140756exp. date 12/2020Lot# 19140757Lot# 19140758exp. date 01/2021Lot# 19141696Lot# 19141793exp. date 03/2021
- Amount recalled
- a) 5,472 bottles and b) 5,880 bottles
Why it was recalled
Failed Dissolution Specifications
This product could cause temporary or reversible health problems — stop using it.
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