D-1829-2019 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- August 28, 2019
- Initiation Date
- July 26, 2019
- Termination Date
- March 10, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 124,038 bottles
Product Description
Clear Eyes Redness Relief Club Pack Display; each display contains 18 3-Pack bottles (UPC 6 78112 10552 6) of Clear eyes REDNESS RELIEF (Glycerin 0.25%, Naphazoline hydrochloride 0.12%) eye drops, 0.5 FL OZ (15 mL) bottle (individual bottle UPC 6 78112 25415 6); Distributed by Medtech Products Inc., Tarrytown, NY 10591, A Prestige Brands Company.
Reason for Recall
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.
Distribution Pattern
Nationwide in the USA and Puerto Rico, St. Michael, Barbados, Guyana, St. Johns, Antigua and Barbuda, Kingston 5, and Jamaica.
Code Information
Lot #: 3-pack Q16299D2, Exp 07/19; Q162300D1, Q16260B1, Q16261B1, Q16263B1, Q16301D1, Q16302D1, Q16303D1, Q16308D1, Q16309D1, Q16336D1, Q16337D1, Q16340D1, Q16342D1, Q16343D1, Q16344D1, Exp 08/19; lot and expiry for individual products within this display are captured in each individual product Code Information