Eye drops Equate and private-label brands recalled for manufacturing documentation deficiency
K.C. Pharmaceuticals is recalling 397,430 bottles of Equate and private-label dry eye relief drops nationwide due to Current Good Manufacturing Practice deficiencies related to fill line documentation.
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: FDA Class II recall for Current Good Manufacturing Practice deficiency regarding fill line documentation. No illnesses or specific product contamination have been reported; the recall addresses a manufacturing process control gap rather than a confirmed safety hazard.
Plain-English summary
K.C. Pharmaceuticals, Inc. is recalling 397,430 bottles of Equate Eye Drops Dry Eye Relief and related private-label versions distributed nationwide. The recalled products are lubricant eye drops containing glycerin, hypromellose, and polyethylene glycol 400.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. The manufacturer identified deficiencies related to a lack of documentation of the fill line during production.
The affected products were distributed under multiple brand names including Equate, DG Health, Sunmark, TopCare Health, HealthMart, Exchange Select, Meijer, H.E.B, and GeriCare. The affected lot numbers are LT21F02 and LT21F03, both expiring in June 2023.
The recalled product
- Product
- EQUATE EYE DROPS DRY EYE RELIEF (GLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400)
- Brand
- EQUATE EYE DROPS DRY EYE RELIEF
- Manufacturer
- K.C. Pharmaceuticals, Inc
- Category
- Drug — Ophthalmic
- Hazard
- cgmp-deviation
- documentation-gap
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 (11)
- Lot #: a) LT21FO2
- LT21F03
- Exp 6/2023
- b) LT21FO2
- c) LT21FO2
- d) LT21FO2
- e) LT21F02
- f) LT21F02
- g) LT21F03
- h) LT21F03
- i) LT21F03
UPCs (13)
- 0681131349864
- 0010939167330
- 0713733296922
- 0357896184056
- 681131367011
- 095072026560
- 010939621443
- 036800361003
- 052569137154
- 614299056206
- 713733296922
- 041220437412
- 357896184056
Distribution
Distributed nationwide across the United States.
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