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.
Reported: December 9, 2020 Initiated: November 24, 2020 #D-0173-2021
Product Description
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.
Reason for Recall
Failed Dissolution Specifications; Out of Specification (low) results were obtained.
Details
- Recalling Firm
- Ascend Laboratories LLC
- Units Affected
- 1200 bottles
- Distribution
- MI
- Location
- Parsippany, NJ
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Ascend Laboratories LLC. Units affected: 1200 bottles.
Why was this product recalled? ▼
Failed Dissolution Specifications; Out of Specification (low) results were obtained.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on December 9, 2020. Severity: Moderate. Recall number: D-0173-2021.
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