FDARecalled May 14, 2025 · #D-0404-2025
Artificial Tears Ophthalmic Solution, Dextran 70.01%/Glycerin 0.2%/Hypromellose 0.3% (Eye Lubricants) Lubricant Eye Drops, STERILE, 0.5 FL OZ (15 mL) per dropper bottle, Distributed by: AvKARE, Pul...
Hazard
Class II — temporary health risk
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cGMP deviations and lack of assurance of sterility. Classification: Class II Distribution: Nationwide in the USA
Product details
- Product
- Artificial Tears Ophthalmic Solution, Dextran 70.01%/Glycerin 0.2%/Hypromellose 0.3% (Eye Lubricants) Lubricant Eye Drops, STERILE, 0.5 FL OZ (15 mL) per dropper bottle, Distributed by: AvKARE, Pulaski, TN 38478, NDC: 50268-043-15.
- Type
- Drugs
- Manufacturer
- BRS Analytical Services, LLC
- Model numbers
- 126, 127, 128, 129, 162, 163, 164, 165, 166, 167, 168, 169, 170, 193, 194, 195, 196, 197, 198, 199
- UPCs
- —