Mylan Recalls Mycophenolic Acid Tablets for Dissolution Failures
Mylan Pharmaceuticals is recalling 7,722 bottles of Mycophenolic Acid Delayed-release Tablets, 180 mg, because they failed to meet dissolution specifications.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity score.
Plain-English summary
Mylan Pharmaceuticals, Inc. is recalling 7,722 bottles of Mycophenolic Acid Delayed-release Tablets, 180 mg, 120-count bottle. The product is identified by NDC 0378-4201-78 and UPC 3 0378-4201-78 7. The specific lot affected is Lot # 3059043 with an expiration date of 08/16.
The recall was initiated because the tablets failed to meet dissolution specifications, resulting in low out-of-specification dissolution results. This means the tablets may not release the medication as intended.
The affected product was distributed nationwide. Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider or pharmacist for a replacement or further instructions.
The recalled product
- Product
- Mycophenolic Acid Delayed-release Tablets, 180 mg, 120-count bottle, Rx only, Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A., NDC 0378-4201-78, UPC 3 0378-4201-78 7.
- Manufacturer
- Mylan Lab Inc
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 7,722
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 (2)
- Lot #: 3059043
- Exp 08/16
Distribution
Distributed nationwide across the United States.
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