FDA Recall D-0176-2025
AvKARE · Pulaski, TN
Class III Ongoing 512 days on record
Lower impact — Class III recall — product violates FDA labeling or manufacturing standards but is unlikely to cause adverse health consequences.
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
Reason for recall
LABELING: LABEL MIX-UP
Recall record
- Recall number
D-0176-2025- Classification
- Class III
- Status
- Ongoing
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- Nationwide within the United States
- Recall initiated
- 2024-12-18
- Classified by FDA Center
- 2025-01-02
- FDA published
- 2025-01-08
- Recalling firm
- AvKARE
- Firm location
- Pulaski, TN
Drug identification
- Brand name(s)
- POLYVINYL ALCOHOL
- Generic name(s)
- POLYVINYL ALCOHOL
- Manufacturer(s)
- AvPAK
- NDC(s)
50268-678- Route(s)
- OPHTHALMIC
Operational response
Class III recalls are unlikely to cause adverse health consequences but indicate a violation of FDA labeling or manufacturing standards. Pull from active dispensing per your operational policy.
For the official FDA enforcement record, see FDA's Recall Search.