December 2020 FDA Recall Refresh Relieva Preservative Free by Allergan, Plc.
D-0233-2021 - Labeling
This Class II drug recall was voluntarily initiated by Allergan, Plc. on December 30, 2020 for the product Refresh Relieva Preservative Free. The FDA reported the reason for recall as labeling. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-0233-2021
Labeling: Missing instructions for use insert
12-30-2020
01-27-2021
100,634 bottles
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Allergan, PLC.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide.
06-21-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Refresh Relieva PF Preservative-Free Lubricant Eye Drops 0.33 fl oz (10 mL) Sterile Distributed by: Allergan, an AbbVie company Madison, NJ 07940 UPC 3 00236 63410 0, NDC 0023-6634-10.
Batch or Lot Expiration Information
Lot# Lots: T0392 Exp. Jul. 2022, T0843 Exp. Aug. 2022
