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.
What this means for you
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
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.
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