FDA Recall D-0668-2024

Ascend Laboratories, LLC · Parsippany, NJ

Class II Ongoing 618 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

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.

Lot / code: 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.

Quantity: 117,493 bottles

Reason for recall

Failed Dissolution Specifications

Recall record

Recall number: D-0668-2024
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Nationwide in the USA and PR
Recall initiated: 2024-09-03
Classified by FDA Center: 2024-09-24
FDA published: 2024-10-02
Recalling firm: Ascend Laboratories, LLC
Firm location: Parsippany, NJ

Drug identification

Brand name(s): MYCOPHENOLIC ACID
Generic name(s): MYCOPHENOLIC ACID
Manufacturer(s): Ascend Laboratories, LLC
NDC(s): 67877-426, 67877-427
Route(s): ORAL

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

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