K C Pharmaceuticals Recalls Eye Drops Due to Warehouse Storage Issues
K C Pharmaceuticals is recalling specific lots of Eye Drops Industrial Strength because the active ingredient was stored in a non-GMP compliant warehouse in Italy.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classified this as a Class III recall, which by definition is unlikely to cause adverse health consequences. The issue is a documentation and storage compliance deviation rather than a direct contamination or injury risk.
Plain-English summary
K C Pharmaceuticals Inc is voluntarily recalling 71,904 bottles of Eye Drops Industrial Strength (Polyethylene glycol 400 1%, Tetrahydrozoline HCl 0.05%), 0.5 FL OZ (15 mL). The affected product is Lot # 3A450 with an expiration date of 01/06. The recall is due to Current Good Manufacturing Practice (CGMP) deviations where the Active Pharmaceutical Ingredient (API) used for manufacture was stored in a non-GMP compliant warehouse at S.I.M.S., Italy.
The recalled product was distributed nationwide in the U.S. and in Ontario, Canada. It was sold under several labels, including Petragon, Inc., SWIFT (Swift First Aid, Inc.), Xpect First aid (Cintas First Aid & Safety), and ZEE (ZEE MEDICAL, INC.).
Consumers should stop using the recalled product and return it to the place of purchase for a refund or contact the recalling firm for instructions.
The recalled product
- 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…
- Manufacturer
- K C Pharmaceuticals Inc
- Category
- Drug — Ophthalmic
- Affected units
- 71,904
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #: 3A450
- Expiry: 01/06.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 recalled by K C Pharmaceuticals Inc under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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