Recalls / Class II
Class IID-1826-2019
Product
Clear Eyes Assorted IRC Display; each display contains 6 each of a) Clear eyes REDNESS RELIEF (Glycerin 0.25%, Naphazoline hydrochloride 0.12%) eye drops, 0.5 FL OZ (15 mL) bottle (UPC 6 78112 25415 6); b) Clear eyes MAXIMUM REDNESS RELIEF (Glycerin 0.5%, Naphazoline hydrochloride 0.03%), 0.5 FL OZ (15 mL) bottle (UPC 6 78112 66577 8); and c) Clear eyes MAXIMUM ITCHY EYE RELIEF (Glycerin 0.25%, Naphazoline hydrochloride 0.012%, Zinc Sulfate 0.25%), 0.5 FL OZ (15 mL) bottle (UPC 6 78112 65920 3); Distributed by Medtech Products Inc., Tarrytown, NY 10591, A Prestige Brands Company, display UPC 6 78112 10452 9.
- Affected lot / code info
- Lot #: Display 17E23A, Exp 12/19; lot and expiry for individual products within this display are captured in each individual product Code Information
Why it was recalled
CGMP Deviations: concerns regarding the sufficiency of Quality Assurance controls over critical systems in the manufacturing facility that could impact the product quality of the finished products.
Recalling firm
- Firm
- Medtech Products, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 660 White Plains Rd Ste 250, N/A, Tarrytown, New York 10591-5171
Distribution
- Quantity
- 20,808 bottles
- Distribution pattern
- Nationwide in the USA and Puerto Rico, St. Michael, Barbados, Guyana, St. Johns, Antigua and Barbuda, Kingston 5, and Jamaica.
Timeline
- Recall initiated
- 2019-07-26
- FDA classified
- 2019-08-16
- Posted by FDA
- 2019-08-28
- Terminated
- 2021-03-10
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1826-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.