Recalls / Class III
Class IIID-0176-2025
Product
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
- Brand name
- Polyvinyl Alcohol
- Generic name
- Polyvinyl Alcohol
- Active ingredient
- Polyvinyl Alcohol
- Route
- Ophthalmic
- NDC
- 50268-678
- FDA application
- M018
- Affected lot / code info
- Lot #: 0160, Exp. Date April 26 2026
Why it was recalled
LABELING: LABEL MIX-UP
Recalling firm
- Firm
- AvKARE
- Manufacturer
- AvPAK
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 615 N 1st St, Pulaski, Tennessee 38478-2403
Distribution
- Quantity
- 0
- Distribution pattern
- Nationwide within the United States
Timeline
- Recall initiated
- 2024-12-18
- FDA classified
- 2025-01-02
- Posted by FDA
- 2025-01-08
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0176-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.