Reported Dec 9, 2020 · Terminated
Tizanidine Tablets, USP 4mg, Rx Only, 150 Tablets per Bottle, Manufactured by Alkem Laboratories Ltd, Mumbai - 400 013,…
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?
- Tizanidine Tablets, USP 4mg, Rx Only, 150 Tablets per Bottle, Manufactured by Alkem Laboratories Ltd, Mumbai - 400 013, INDIA
- Distributed byAscend Laboratories, LLC Parsippany, NJ 07054
- NDC67877-614-15
- Lot codes and dates
Lot #19143017Exp. 05/31/2021
- Amount recalled
- 1200 bottles
Where it was sold
Why it was recalled
Failed Dissolution Specifications; Out of Specification (low) results were obtained.
This product could cause temporary or reversible health problems — stop using it.
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