FDA Drug Class II — Moderate

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.

Hazard

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

Products

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.
Brand
Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
UPC
Lot Number: 3034630; Expiration Date: 12/13; NDC: 51079-182-20

Units Affected

11,650 cartons