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.
What this means for you
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
- 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.
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