Agency classClass IIOur severity:High FDA (Drugs)·D-0668-2024·Announced 2024-10-02

Prescription immunosuppressant tablets recalled due to failed dissolution specifications

Ascend Laboratories recalled 117,493 bottles of Mycophenolic Acid tablets nationwide because the tablets failed to meet dissolution specifications. Patients taking this medication should consult their doctor.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is a Class II FDA recall with no reported illnesses or hospitalizations. Per the severity rubric, products with risk of harm where injury has not yet been reported score as High (3). Failed dissolution specifications create a potential risk to therapeutic efficacy in immunosuppressed patients.

Plain-English summary

Ascend Laboratories is recalling 117,493 bottles of Mycophenolic Acid Delayed-Release Tablets USP, 360 mg, distributed nationwide in the United States and Puerto Rico. This is a prescription immunosuppressant medication.

The tablets failed to meet dissolution specifications, which led to this recall.

The affected lot numbers are 22123437, 22123438, 22123535, 22123536, 22123537, 22123538, 22123646, 22123647, 23120529, 23120530, 23120703, 23120705, 23121429, 23121726, 23122049, 23122097, 23121984, 23121985, 23121986, 23122325, 23122329, 23122330, 23122331, 23122776, 23122852, 23122853, 23123154, 23123155, and 23123458, with expiration dates from September 2024 through September 2026. The product carries NDC 67877-427-12 and was manufactured by Alkem Laboratories in India.

Patients currently taking this medication should verify their prescription bottle's lot number and expiration date. Those with affected bottles should contact their healthcare provider or pharmacist for instructions.

The recalled product

Product: MYCOPHENOLIC ACID (MYCOPHENOLIC ACID)
Brand: MYCOPHENOLIC ACID
Manufacturer: Ascend Laboratories, LLC
Category: Drug — Immunosuppressant
Hazard: dissolution-failure
efficacy-risk
Affected units: 117,493

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

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

UPCs (1)

0367877427126

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Same manufacturer · Ascend Laboratories, LLC

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