PlainRecalls
FDA Drug Moderate Class II Terminated

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.

Reported: January 28, 2015 Initiated: September 26, 2013 #D-0377-2015

Product Description

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.

Reason for Recall

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

Details

Units Affected
11,650 cartons
Distribution
Nationwide and Puerto Rico.
Location
Rockford, IL

Frequently Asked Questions

What product 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.. Recalled by Mylan Institutional, Inc. (d.b.a. UDL Laboratories). Units affected: 11,650 cartons.
Why was this product recalled?
CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices
Which agency issued this recall?
This recall was issued by the FDA Drug on January 28, 2015. Severity: Moderate. Recall number: D-0377-2015.