Recalls / Class II
Class IID-1823-2019
Product
Clear eyes REDNESS RELIEF (Glycerin 0.25%, Naphazoline hydrochloride 0.012%) eye drops, Handy Pocket Pal, 0.2 FL OZ (6 mL) bottle, Dist. by Lil' Drug Store Products Inc., 1201 Continental Place NE, Cedar Rapids, IA 52402; Medtech Products Inc., Tarrytown, NY 10591, UPC 7 92554 70103 7.
- Affected lot / code info
- Lot #: 16321, Exp 11/19; 16336, Exp 12/19; 17012, Exp 01/20; 17034, 17051, Exp 02/20; 17147, Exp 05/20
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
- 1,621,200 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-1823-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.