Status
Ongoing
Drug Enforcement D-0668-2024
Failed Dissolution Specifications
Classification
Class II
Report Date
October 2, 2024
Termination Date
—
Product Information
- 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.
- Product quantity
- 117,493 bottles
- Reason for recall
- Failed Dissolution Specifications
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide in the USA and PR
Location & Firm
- Recalling firm
- Ascend Laboratories, LLC
- Address
-
339 Jefferson Rd Ste 101
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0668-2024
- Event ID
- 95275
- Recall initiation date
- September 3, 2024
- Center classification date
- September 24, 2024
- 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.
- More code info
- —