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.
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 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
- 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
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