Recalls / Class III

Class IIID-0322-2015

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.

Affected lot / code info

Lot #: 3A450, Expiry: 01/06.

Why it was recalled

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

Recalling firm

Firm

K C Pharmaceuticals Inc

Notification channel

Letter

Type

Voluntary: Firm initiated

Address

3201 Producer Way, Pomona, California 91768-3916

Distribution

Quantity

71904 Bottles

Distribution pattern

U.S. Nationwide and Canada (Ontario).

Timeline

Recall initiated

2014-12-04

FDA classified

2014-12-23

Posted by FDA

2014-12-31

Terminated

2015-10-26

Status

Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-0322-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.