Why it was recalled
LABELING: LABEL MIX-UP
Product description
Polyvinyl Alcohol Ophthalmic Solution 1.4%, Moisturizing Lubricant Eye Drops, 0.5 FL OZ (15 mL) bottles, Distributed by AvKARE, Pulaski, TN 38478, www.avkare.com, NDC 50268-678-15
Lot numbers, UPCs & expiration codes
Lot #: 0160, Exp. Date April 26 2026
Where it was sold
Nationwide within the United States
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-0176-2025
- Classification
- Class III
- Status
- Ongoing
- Recall initiated
- Dec 18, 2024
- FDA report date
- Jan 8, 2025
- Quantity
- 0
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- AvKARE
Original FDA data
Every field from FDA enforcement report D-0176-2025, exactly as published.
Show all FDA fields
- City
- Pulaski
- State
- TN
- Status
- Ongoing
- Country
- United States
- Event ID
- 96032
- Address
- 615 N 1st St
- Code information
- Lot #: 0160, Exp. Date April 26 2026
- Postal code
- 38478-2403
- Report date
- Jan 8, 2025
- Product type
- Drugs
- Recall number
- D-0176-2025
- Classification
- Class III
- Recalling firm
- AvKARE
- Product quantity
- 0
- Reason for recall
- LABELING: LABEL MIX-UP
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Polyvinyl Alcohol Ophthalmic Solution 1.4%, Moisturizing Lubricant Eye Drops, 0.5 FL OZ (15 mL) bottles, Distributed by AvKARE, Pulaski, TN 38478, www.avkare.com, NDC 50268-678-15
- Distribution pattern
- Nationwide within the United States
- Recall initiation date
- Dec 18, 2024
- Initial firm notification
- Letter
- Center classification date
- Jan 2, 2025