D-0233-2021 Class II Terminated
FDA drug recall D-0233-2021 was initiated by Allergan, PLC. on Dec 30, 2020 and is designated Class II. Reason for recall: Labeling: Missing instructions for use insert The recall status is terminated (terminated Jun 21, 2023). Affected quantity: 100,634 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- Jan 27, 2021
- Initiation Date
- Dec 30, 2020
- Termination Date
- Jun 21, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 100,634 bottles
Product Description
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.
Reason for Recall
Labeling: Missing instructions for use insert
Distribution Pattern
Nationwide.
Code Information
Lots: T0392 Exp. Jul. 2022, T0843 Exp. Aug. 2022
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0233-2021
- openFDA file date
- Oct 6, 2026
- Loaded by RegDataLab
- Oct 12, 2026