The Recall Desk
ModerateFDA (Drugs)·D-1111-2015·Announced 2015-06-10

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.

What this means for you

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.

Related recalls

Same hazard · dissolution failure

See all →