FDA-Drug2015-06-10Class II

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.

Mylan Lab Inc
Hazard

Failed Dissolution Specifications: Low out of specification dissolution results.

Sold states
Nationwide
Affected count
7,722 bottles
Manufactured in
1500 Corporate Dr Ste 400, N/A, Canonsburg, PA, United States
Products
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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1111-2015

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