Recalls / Class II
Class IID-0233-2021
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.
- Brand name
- Refresh Relieva Preservative Free
- Generic name
- Carboxymethylcellulose Sodium And Glycerin
- Active ingredients
- Carboxymethylcellulose Sodium, Glycerin
- Route
- Ophthalmic
- NDC
- 0023-6634
- FDA application
- M018
- Affected lot / code info
- Lots: T0392 Exp. Jul. 2022, T0843 Exp. Aug. 2022
Why it was recalled
Labeling: Missing instructions for use insert
Recalling firm
- Firm
- Allergan, PLC.
- Manufacturer
- Allergan, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 5 Giralda Farms, N/A, Madison, New Jersey 07940-1027
Distribution
- Quantity
- 100,634 bottles
- Distribution pattern
- Nationwide.
Timeline
- Recall initiated
- 2020-12-30
- FDA classified
- 2021-01-19
- Posted by FDA
- 2021-01-27
- Terminated
- 2023-06-21
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0233-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.