The Recall Desk
Agency classClass IIIOur severity:ModerateFDA (Drugs)·D-0321-2015·Announced 2014-12-31

KC Pharmaceuticals Recalls Eye Drops Due to Non-GMP API Storage

KC Pharmaceuticals is recalling 302,976 bottles of Eye Drops A.C. 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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class III, which indicates a low probability of adverse health consequences. The hazard is a CGMP deviation regarding API storage, which is a quality control issue rather than a direct contamination or mislabeling of a common allergen.

Plain-English summary

KC Pharmaceuticals Inc. is voluntarily recalling 302,976 bottles of Eye Drops A.C. (Tetrahydrozoline HCl 0.05%, Zinc sulfate 0.25%), 0.5 FL OZ (15 mL) bottles. The product is available over the counter under various brand names, including Safeway, Best Choice, Equaline, GoodSense, H-E-B, and Kroger.

The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. Specifically, the Active Pharmaceutical Ingredient (API) used for the manufacture of these eye drops was stored in a non-GMP compliant warehouse located at S.I.M.S. in Italy. The affected lots include 3B251, 3B250, 3C252, and 3C253, all with expiration dates of 02/16 or 03/16.

The product was distributed nationwide in the United States and in Ontario, Canada. Consumers who have purchased these products should stop using them and return them to the place of purchase for a refund.

The recalled product

Product
Eye Drops A.C. (Tetrahydrozoline HCl 0.05%, Zinc sulfate 0.25%), 0.5 FL OZ (15 mL) Bottles, Over the Counter. Labeled: a) Astringent Redness Reliever, Distributed by Safeway Inc., P.O. Box 99, Pleasanton, CA 94566-0009, UPC: 3 21130 70067 8; b) Best Choice, Distributed By: Valu…
Manufacturer
K C Pharmaceuticals Inc
Category
Drug — Ophthalmic
Hazard
Affected units
302,976

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 (7)

  • Lot #: 3B251
  • Expiry: 02/16
  • Lot #: 3B250
  • Lot #: 3C252
  • Expiry: 03/16
  • Lot #: 3C253
  • Expiry: 03/16.

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.

See all 4 products in this recall →

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