K C Pharmaceuticals Inc recalls Eye Drops Industrial Strength (Polyethylene glycol 400 1%, Tetrahydrozoline HCl 0.05%), 0.5 FL OZ (15 mL) Bottles, Over

Recalled December 31, 2014 · FDA recall D-0322-2015 · K C Pharmaceuticals

Hazard

CGMP Deviations: Active Pharmaceutical Ingredient (API) used for manufacture was stored in a non-GMP compliant warehouse at S.I.M.S., Italy. · FDA Class III

Units

71904 Bottles

Sold at

U.S. Nationwide and Canada (Ontario).

Description

CGMP Deviations: Active Pharmaceutical Ingredient (API) used for manufacture was stored in a non-GMP compliant warehouse at S.I.M.S., Italy.

Product

Eye Drops Industrial Strength (Polyethylene glycol 400 1%, Tetrahydrozoline HCl 0.05%), 0.5 FL OZ (15 mL) Bottles, Over the Counter. Labeled: a) Manufactured for: Petragon, Inc., Edwardsville, KS 66111; b) SWIFT, Distributed by Swift First Aid, Inc., Valencia, Calif. 91355, UPC: 6 69635 24082 5; c) Xpect First aid, Manufactured for Cintas First Aid & Safety, Mason, OH 45040; d) ZEE, Distributed by ZEE MEDICAL, INC., Irvine, CA 92606, UPC: 6 90689 00609 9.

Manufacturer(s)

K C Pharmaceuticals Inc

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →