FDA-Drug2020-12-09Class II
Tizanidine Tablets, USP 4mg, Rx Only, 150 Tablets per Bottle, Manufactured by Alkem Laboratories Ltd, Mumbai - 400 013, INDIA, Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054, NDC: 67877-614-15.
Ascend Laboratories LLC
Hazard
Failed Dissolution Specifications; Out of Specification (low) results were obtained.
Sold states
MI
Affected count
1200 bottles
Manufactured in
339 Jefferson Rd Ste 101, N/A, Parsippany, NJ, United States
Products
Tizanidine Tablets, USP 4mg, Rx Only, 150 Tablets per Bottle, Manufactured by Alkem Laboratories Ltd, Mumbai - 400 013, INDIA, Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054, NDC: 67877-614-15.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0173-2021Don't want to check this manually?
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