CIPROFLOXACIN TABLETS recalled over manufacturing violations

Recall date

September 26, 2013

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Mylan Institutional, Inc. (d.b.a. UDL Laboratories) recalls CIPROFLOXACIN TABLETS, USP, 500 mg, 100 Tablets (10 tablets per blister card. 10 blister cards per carton), Manufacture…

Recall number

D-0377-2015

FDA classification

Class II

Brand / firm

Mylan Institutional, Inc. (d.b.a. UDL Laboratories)

Sold / distributed

Nationwide and Puerto Rico.

Why it was recalled

CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices

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

What was recalled

CIPROFLOXACIN TABLETS, USP, 500 mg, 100 Tablets (10 tablets per blister card. 10 blister cards per carton), Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV --- NDC 51079-182-20.