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.

FDA recall notice · announced June 10, 2015 · Mylan Lab

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The 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.

Reason for recall

Failed Dissolution Specifications: Low out of specification dissolution results.

Notes

Distribution: Nationwide
Lot/code information: Lot #: 3059043, Exp 08/16
Quantity: 7,722 bottles
Status: Terminated
Products in this recall event:
- 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. (D-1111-2015)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.