Recalls / Class II
Class IID-0668-2024
Product
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.
- Brand name
- Mycophenolic Acid
- Generic name
- Mycophenolic Acid
- Active ingredient
- Mycophenolate Sodium
- Route
- Oral
- NDCs
- 67877-426, 67877-427
- FDA application
- ANDA208315
- Affected 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.
Why it was recalled
Failed Dissolution Specifications
Recalling firm
- Firm
- Ascend Laboratories, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 339 Jefferson Rd Ste 101, Parsippany, New Jersey 07054-3707
Distribution
- Quantity
- 117,493 bottles
- Distribution pattern
- Nationwide in the USA and PR
Timeline
- Recall initiated
- 2024-09-03
- FDA classified
- 2024-09-24
- Posted by FDA
- 2024-10-02
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0668-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.