CLASS III Drug recall · Reported 31 Dec 2014 · FDA Enforcement Report
Eye Drops Industrial Strength (Polyethylene glycol recalled
K C Pharmaceuticals is recalling Eye Drops Industrial Strength (Polyethylene glycol 400 1%, Tetrahydrozoline HCl 0.05%), distributed nationwide in the US. The recall was initiated on 4 Dec 2014 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0322-2015
- FDA event ID
- 69945
- Recalling firm
- K C Pharmaceuticals, Pomona, CA
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 4 Dec 2014
- FDA classified
- 23 Dec 2014
- Reported
- 31 Dec 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Manufacturing (CGMP) Deviations
- Drug class
- Stomach & Acid Reflux Medication
Timeline
| 4 Dec 2014 | Recall initiated by company | |
| 23 Dec 2014 | Classified by FDA | +19 days |
| 31 Dec 2014 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
CGMP Deviations: Active Pharmaceutical Ingredient (API) used for manufacture was stored in a non-GMP compliant warehouse at S.I.M.S., Italy.
Product as listed by the FDA
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.
Where it was distributed
U.S. Nationwide and Canada (Ontario).
Questions about this recall
Why was it recalled?
CGMP Deviations: Active Pharmaceutical Ingredient (API) used for manufacture was stored in a non-GMP compliant warehouse at S.I.M.S., Italy.
Which lots are affected?
Lot #: 3A450, Expiry: 01/06.
Where was it sold?
U.S. Nationwide and Canada (Ontario).
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
3 other products · FDA event 69945This product is part of a recall event; the main page for the event is Eye Drops A.C. (Tetrahydrozoline HCl recalled by K C Pharmaceuticals.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS III | Eye Drops A.C. (Tetrahydrozoline HCl recalled by K C Pharmaceuticals | K C Pharmaceuticals | Manufacturing (CGMP) Deviations | Nationwide | |
| CLASS III | Eye Drops Advanced Relief (Dextran recalled by K C PharmaceuticalsSunmark Eye Drops Advanced Moisturizer/lubricant | K C Pharmaceuticals | Manufacturing (CGMP) Deviations | Nationwide | |
| CLASS III | Eye Drops (Tetrahydrozoline HCl 0.05%), Over the Counter recalledSunmark Eye Drops Original Formula | K C Pharmaceuticals | Manufacturing (CGMP) Deviations | Nationwide |
More recalls from K C Pharmaceuticals
All 15| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Sterile Eye Drops Soothing Tears recalled by K.C. Pharmaceuticals | K.C. Pharmaceuticals | Sterility | Nationwide |
| Drug | CLASS II | Sterile EYE Drops AC (tetrahydrozoline HCl recalledQuality Choice Eye Drops Irritation Relief | K.C. Pharmaceuticals | Sterility | Nationwide |
| Drug | CLASS II | EYE Drops Advanced Relief, (dextran recalled by K.C. PharmaceuticalsQuality Choice Moisturizing Relief Eye Drops | K.C. Pharmaceuticals | Sterility | Nationwide |
| Drug | CLASS II | Sterile Eye Drops Redness Lubricant (glycerin recalledLeader Eye Drops Redness Relief | K.C. Pharmaceuticals | Sterility | Nationwide |
| Drug | CLASS II | Dry Eye Relief Eye Drops, (glycerin recalled by K.C. PharmaceuticalsArtificial Tears | K.C. Pharmaceuticals | Sterility | Nationwide |