Mycophenolic Acid Delayed-Release Tablets USP, 360 mg, Rx Only, 120 Tablets per bottle, Manufactured by Alkem Laboratories, LTD, INDIA; Distributed by Ascend Laboratories, LLC, Parsippany, NJ 07054, NDC 67877-427-12.
Reported: October 2, 2024 Initiated: September 3, 2024 #D-0668-2024
Product Description
Mycophenolic Acid Delayed-Release Tablets USP, 360 mg, Rx Only, 120 Tablets per bottle, Manufactured by Alkem Laboratories, LTD, INDIA; Distributed by Ascend Laboratories, LLC, Parsippany, NJ 07054, NDC 67877-427-12.
Reason for Recall
Failed Dissolution Specifications
Details
- Recalling Firm
- Ascend Laboratories, LLC
- Units Affected
- 117,493 bottles
- Distribution
- Nationwide in the USA and PR
- Location
- Parsippany, NJ
Frequently Asked Questions
What product was recalled? ▼
Mycophenolic Acid Delayed-Release Tablets USP, 360 mg, Rx Only, 120 Tablets per bottle, Manufactured by Alkem Laboratories, LTD, INDIA; Distributed by Ascend Laboratories, LLC, Parsippany, NJ 07054, NDC 67877-427-12.. Recalled by Ascend Laboratories, LLC. Units affected: 117,493 bottles.
Why was this product recalled? ▼
Failed Dissolution Specifications
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on October 2, 2024. Severity: Moderate. Recall number: D-0668-2024.
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