Reported Dec 31, 2014 · Terminated

Eye Drops Industrial Strength (Polyethylene glycol 400 1%, Tetrahydrozoline HCl 0.05%), 0.5 FL OZ (15 mL) Bottles, Over…

K C Pharmaceuticals Inc.

Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: K C Pharmaceuticals Inc · 3201 Producer Way · Pomona, CA · 91768-3916

Is this the product you have?

Eye Drops Industrial Strength (Polyethylene glycol 400 1%, Tetrahydrozoline HCl 0.05%), 0.5 FL OZ (15 mL) Bottles, Over the Counter. Labeled

4 of 4 products

Products covered by this recall
#Product as published
1Manufactured for: Petragon, Inc., Edwardsville, KS 66111
2SWIFT, Distributed by Swift First Aid, Inc., Valencia, Calif. 91355, UPC: 6 69635 24082 5
3Xpect First aid, Manufactured for Cintas First Aid & Safety, Mason, OH 45040
4ZEE, Distributed by ZEE MEDICAL, INC., Irvine, CA 92606, UPC: 6 90689 00609 9.
Lot codes and dates
  • Lot #: 3A450
  • Expiry01/06
Amount recalled
71904 Bottles

This recall covers 4 products

The agency filed one notice per product. You are reading one of them; the other 3 are below.

Where it was sold

  • Nationwide

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.

This product is unlikely to cause harm, but it breaks a safety or labelling rule.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Oct 26, 2015 · Data as of Sep 19, 7:53 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.