Agency classClass IIIOur severity:Low FDA (Drugs)·D-0323-2015·Announced 2014-12-31

KC Pharmaceuticals Recalls Sunmark Eye Drops for CGMP Deviations

KC Pharmaceuticals is recalling Sunmark Eye Drops Advanced Moisturizer/Lubricant 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 recall as Class III, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences.

Plain-English summary

KC Pharmaceuticals Inc. is recalling 427,512 bottles of Sunmark Eye Drops Advanced Moisturizer/Lubricant (Dextran, Polyethylene Glycol 400, Povidone, Tetrahydrozoline). The product is an over-the-counter ophthalmic solution distributed in the U.S. nationwide and in Ontario, Canada, under various store brands including Safeway, Best Choice, Equaline, and Wal-Mart Canada.

The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. Specifically, the Active Pharmaceutical Ingredient (API) used for the manufacture of the eye drops was stored in a non-GMP compliant warehouse located in S.I.M.S., Italy. The affected lots are 3A350, 3B351, 3C352, 3C353, and 3C354, with expiration dates ranging from January 2016 to March 2016.

The FDA has classified this recall as Class III, indicating that use of or exposure to the violative product is not likely to cause adverse health consequences. Consumers should stop using the recalled product and return it to the place of purchase for a refund or follow instructions provided by the recalling firm.

The recalled product

Product: SUNMARK EYE DROPS ADVANCED MOISTURIZER/LUBRICANT (DEXTRAN, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE)
Brand: SUNMARK EYE DROPS ADVANCED MOISTURIZER/LUBRICANT
Manufacturer: K C Pharmaceuticals Inc
Category: Drug — Ophthalmic
Hazard: cgmp-deviation
Affected units: 427,512

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 (9)

Lot #: 3A350
Expiry: 01/16
Lot #: 3B351
Expiry: 02/16
Lot #: 3C352
Expiry: 03/16
Lot #: 3C353
Lot #: 3C354
Expiry: 03/16.

UPCs (22)

321130700647
070038470090
041163253926
183164000229
614299396258
087701106637
180410000194
041220891375
052569134740
725439933834
075450297782
011110385987
057800156406
041310620434
095072012518
041250829171
070253966835
041415067769
015127003643
010939168337
036800036413
015400032810

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 →

Same manufacturer · K C Pharmaceuticals Inc

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Same hazard · cgmp deviation