drugs Class III Updated 2014-12-31

K C Pharmaceuticals Inc recalls Eye Drops Industrial Strength (Polyethylene glycol 400 1%, T

Recalled 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.

Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot #: 3A450, Expiry: 01/06.
View official government recall

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