FDA Recall D-0175-2025
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
Carboxymethylcellulose Sodium Ophthalmic Solution 0.5% Moisturizing Lubricant Eye Drops, 0.5 FL OZ (15 mL) bottles, Distributed by: AvKARE, Pulaski, TN, 38478, NDC 50268-068-15.
Reason for recall
LABELING: LABEL MIX-UP
Recall record
- Recall number
D-0175-2025- 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)
- CARBOXYMETHYLCELLULOSE SODIUM
- Generic name(s)
- CARBOXYMETHYLCELLULOSE SODIUM
- Manufacturer(s)
- AvPAK
- NDC(s)
50268-068- 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.