Class II
Ongoing
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.
This recall is currently active, issued October 2, 2024. It was issued by Ascend Laboratories, Llc.
- Company
- Ascend Laboratories, Llc
- Recall Initiated
- September 3, 2024
- Posted
- October 2, 2024
- Recall Number
- D-0668-2024
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 117,493 bottles
- Firm Location
- Parsippany, NJ, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Failed Dissolution Specifications
Distribution
Nationwide in the USA and PR
Lot / Code Info
Lots 22123437, 22123438, 22123535, Exp Date 9/30/24; 22123536, 22123537, 22123538, 22123646, 22123647, Exp Date 10/31/24; 23120529, 23120530, Exp Date 1/31/25; 23120703, 23120705, Exp Date 2/28/25; 23121429, 23121726, 23122049, 23122097, Exp Date, 4/30/25; 23121984, 23121985, 23121986, Exp Date 5/31/25; 23122325, 23122329, 23122330, 23122331, Exp Date 6/30/26; 23122776, 23122852, 23122853, 23123154, 23123155, Exp Date 8/31/26; 23123458, Exp Date 9/30/26.
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