Medtech Recalls Clear Eyes Itchy Eye Relief Due to Quality Control Issues
Medtech Products is recalling 1,752 bottles of Clear Eyes Maximum Itchy Eye Relief due to concerns about quality assurance controls in the manufacturing facility.
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 recall is classified as FDA Class II, which typically involves a situation that might cause temporary or medically reversible health consequences. The source cites CGMP deviations and quality assurance concerns without reporting specific illnesses or injuries, fitting the criteria for a moderate severity score.
Plain-English summary
Medtech Products, Inc. is recalling 1,752 bottles of Clear Eyes Maximum Itchy Eye Relief eye drops. The affected product is sold in 0.5 FL OZ (15 mL) bottles and is part of a Sidekick Floor Stand Display containing 12 bottles each. The recall covers specific lots with expiration dates of 12/19.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. Specifically, there are concerns regarding the sufficiency of Quality Assurance controls over critical systems in the manufacturing facility, which could impact the quality of the finished products. The agency has classified this as a Class II recall.
The product was distributed nationwide in the USA and Puerto Rico, as well as in St. Michael, Barbados, Guyana, St. Johns, Antigua and Barbuda, Kingston 5, and Jamaica. Consumers should stop using the product and contact the recalling firm for instructions on how to return it or obtain a refund.
The recalled product
- Product
- Clear Eyes Maximum Itchy Eye Relief Sidekick Floor Stand Display; each display contains 12 each of Clear eyes MAXIMUM ITCHY EYE RELIEF (Glycerin 0.25%, Naphazoline hydrochloride 0.012%, Zinc Sulfate 0.25%) eye drops, 0.5 FL OZ (15 mL) bottle, (UPC 6 78112 65920 30; Distributed by
- Manufacturer
- Medtech Products, Inc.
- Category
- Drug — Ophthalmic
- Affected units
- 1,752
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 (3)
- Lot #: 16331
- 16344
- EXP 12/19
Distribution
Part of a larger recall action
This product is one of 14 recalled by Medtech Products, 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 14 products in this recall →Related recalls
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