Recalls / Class III
Class IIID-0175-2025
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.
- Brand name
- Carboxymethylcellulose Sodium
- Generic name
- Carboxymethylcellulose Sodium
- Active ingredient
- Carboxymethylcellulose Sodium, Unspecified Form
- Route
- Ophthalmic
- NDC
- 50268-068
- 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
- 16,677 cartons
- 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-0175-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.