Polyvinyl Alcohol Ophthalmic Solution 1.4%, Lubricant Eye Drops, Moisturizing, Sterile, 0.5 FL OZ (15mL) per dropper bottle, Distributed by: AvKARE, Pulaski, TN 38478, NDC: 50268-678-15.
Reported: May 14, 2025 Initiated: April 23, 2025 #D-0408-2025
Product Description
Polyvinyl Alcohol Ophthalmic Solution 1.4%, Lubricant Eye Drops, Moisturizing, Sterile, 0.5 FL OZ (15mL) per dropper bottle, Distributed by: AvKARE, Pulaski, TN 38478, NDC: 50268-678-15.
Reason for Recall
cGMP deviations and lack of assurance of sterility.
Details
- Recalling Firm
- BRS Analytical Services, LLC
- Units Affected
- 14,333 cases (24 cartons per case)
- Distribution
- Nationwide in the USA
- Location
- Saint Louis, MO
Frequently Asked Questions
What product was recalled? ▼
Polyvinyl Alcohol Ophthalmic Solution 1.4%, Lubricant Eye Drops, Moisturizing, Sterile, 0.5 FL OZ (15mL) per dropper bottle, Distributed by: AvKARE, Pulaski, TN 38478, NDC: 50268-678-15.. Recalled by BRS Analytical Services, LLC. Units affected: 14,333 cases (24 cartons per case).
Why was this product recalled? ▼
cGMP deviations and lack of assurance of sterility.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on May 14, 2025. Severity: Moderate. Recall number: D-0408-2025.
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