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.
FDA recall notice · announced January 28, 2015 · Mylan Institutional, Inc. (d.b.a. Udl Laboratories)
Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.
The product
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
Notes
Distribution: Nationwide and Puerto Rico.
Lot/code information: Lot Number: 3034630; Expiration Date: 12/13; NDC: 51079-182-20
Quantity: 11,650 cartons
Status: Terminated
Products in this recall event:
- LAMOTRIGINE TABLETS, 200 mg, 100 Tablets (10 tablets per blister card x 10 blister cards per carton), Rx only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV --- NDC 51079-866-20 (D-0378-2015)
- 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. (D-0377-2015)
Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.