Recalls / Class II
Class IID-1834-2019
Product
Clear eyes REDNESS RELIEF (Glycerin 0.25%, Naphazoline hydrochloride 0.012%) eye drops, Handy Pocket Pal, 0.2 FL OZ (6 mL) bottle, Distributed by Select Corporation, Carrolton, TX 75007; Medtech Products Inc., Tarrytown, NY 10591, A Prestige Brands Company, UPC 6 55708 01039 6.
- Affected lot / code info
- Lot #: 16192, 16203, Exp 07/19; 16321, Exp 11/19; 17002, Exp 01/20; 17034, Exp 02/20
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
- 1,030,128 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-1834-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.