Drug & medication recalls Moderate risk

Mylan Lab Inc recalls Mycophenolic Acid Delayed-release Tablets, 180 mg, 120-count bottle, Rx only, Mylan Pharmaceuticals, Inc., Morgantown,…

Recall date
May 20, 2015
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
D-1111-2015
FDA classification
Class II
Brand / firm
Mylan Lab Inc
Sold / distributed
Nationwide

Why it was recalled

Failed Dissolution Specifications: Low out of specification dissolution results.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.

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