PlainRecalls
FDA Drug Moderate Class II Terminated

Ciprofloxacin Tablets, USP, 500 mg,100-count bottles, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A, NDC 0378-7098-01

Reported: November 13, 2013 Initiated: September 13, 2013 #D-66403-011

Product Description

Ciprofloxacin Tablets, USP, 500 mg,100-count bottles, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A, NDC 0378-7098-01

Reason for Recall

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

Details

Units Affected
941,270 bottles
Distribution
Nationwide and Puerto Rico
Location
Morgantown, WV

Frequently Asked Questions

What product was recalled?
Ciprofloxacin Tablets, USP, 500 mg,100-count bottles, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A, NDC 0378-7098-01. Recalled by Mylan Pharmaceuticals Inc.. Units affected: 941,270 bottles.
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 November 13, 2013. Severity: Moderate. Recall number: D-66403-011.