The Recall Desk
ModerateFDA (Drugs)·D-0320-2015·Announced 2014-12-31

Sunmark Eye Drops Recalled for Non-GMP API Storage

K C Pharmaceuticals is recalling Sunmark Eye Drops because the active ingredient was stored in a non-GMP compliant warehouse in Italy.

What this means for you

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 FDA classified this as a Class III recall, which indicates a remote possibility 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

K C Pharmaceuticals Inc is recalling 751,440 bottles of Sunmark Eye Drops Original Formula (Tetrahydrozoline HCl 0.05%). The product is an over-the-counter ophthalmic solution available in 0.5 FL OZ (15 mL) bottles.

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. This storage condition may affect the quality of the medication.

The affected products were distributed nationwide in the United States and in Ontario, Canada, under various store brands including Sunmark, Good Neighbor Pharmacy, H-E-B, and Kroger. Consumers should check their lot numbers against the following: 3A001, 3A002, 3B004, 3B003, 3C005, 3C006, 3D007, and 3D008. All affected lots have expiration dates ranging from January 2016 to April 2016. Consumers should stop using the product and contact their pharmacist or the manufacturer for a refund or replacement.

The recalled product

Product
SUNMARK EYE DROPS ORIGINAL FORMULA (TETRAHYDROZOLINE HCL)
Brand
SUNMARK EYE DROPS ORIGINAL FORMULA
Manufacturer
K C Pharmaceuticals Inc
Category
Drug — Ophthalmic
Hazard
Affected units
751,440

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 (13)

  • Lot #: 3A001
  • Expiry: 01/16
  • Lot #: 3A002
  • Lot #: 3B004
  • Expiry: 02/16
  • Lot #: 3B003
  • Lot #: 3C005
  • Expiry: 03/16
  • Lot #: 3C006
  • Lot #: 3D007
  • Expiry: 04/16
  • Lot #: 3D008
  • Expiry: 04/16.

UPCs (27)

  • 0010939167330
  • 070038470113
  • 761706165003
  • 041163251106
  • 060383736132
  • 032251004599
  • 087701149757
  • 180410000156
  • 041220947317
  • 052569134726
  • 725439933803
  • 075450296044
  • 011110385970
  • 057800196167
  • 041310620427
  • 041250829164
  • 070253966842
  • 041415010765
  • 321130700609
  • 771058101604
  • 015127000666
  • 720007780360
  • 010939167330
  • 669635240610
  • 036800036390
  • 015400034203
  • 690689006143

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 →

Related recalls

Same brand · SUNMARK EYE DROPS ORIGINAL FORMULA

Same manufacturer · K C Pharmaceuticals Inc

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Same hazard · cgmp deviation

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