Why it was recalled
Labeling: Missing instructions for use insert
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.
Lot numbers, UPCs & expiration codes
Lots: T0392 Exp. Jul. 2022, T0843 Exp. Aug. 2022
Where it was sold
Nationwide.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0233-2021
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Dec 30, 2020
- FDA report date
- Jan 27, 2021
- Quantity
- 100,634 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Allergan, PLC.
Original FDA data
Every field from FDA enforcement report D-0233-2021, exactly as published.
Show all FDA fields
- City
- Madison
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 87016
- Address
- 5 Giralda Farms
- Code information
- Lots: T0392 Exp. Jul. 2022, T0843 Exp. Aug. 2022
- Postal code
- 07940-1027
- Report date
- Jan 27, 2021
- Product type
- Drugs
- Recall number
- D-0233-2021
- Classification
- Class II
- Recalling firm
- Allergan, PLC.
- Product quantity
- 100,634 bottles
- Termination date
- Jun 21, 2023
- Reason for recall
- Labeling: Missing instructions for use insert
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Distribution pattern
- Nationwide.
- Recall initiation date
- Dec 30, 2020
- Initial firm notification
- Letter
- Center classification date
- Jan 19, 2021