Recalls / Class II
Class IID-0404-2025
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.
- Brand name
- Artificial Tears
- Generic name
- Artificial Tears
- Active ingredients
- Dextran 70, Glycerin, Hypromelloses
- Route
- Ophthalmic
- NDC
- 50268-043
- FDA application
- M018
- Affected lot / code info
- Lot, expiry: Lot 126, exp 10/26/25; Lot 127, exp 10/30/25; Lot 128, exp 11/02/25; Lot 129, exp 11/06/25; Lot 162, exp 5/09/26; Lot 163, exp 5/14/26; Lot 164, exp 5/20/26; Lot 165, exp 5/23/26; Lot 166, exp 5/29/26; Lot 167, exp 6/03/26; Lot 168, exp 6/06/26; Lot 169, exp 6/10/26; Lot 170, exp 6/13/26; Lot 193, exp 10/07/26; Lot 194, exp 10/10/26; Lot 195, exp 10/14/26; Lot 196, exp 10/17/26; Lot 197, exp 10/21/26; Lot 198, exp 10/24/26; Lot 199, exp 10/30/26.
Why it was recalled
cGMP deviations and lack of assurance of sterility.
Recalling firm
- Firm
- BRS Analytical Services, LLC
- Manufacturer
- AvPAK
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 11697 Lakeside Crossing Ct, N/A, Saint Louis, Missouri 63146-8606
Distribution
- Quantity
- 13,872 cases (24 cartons per case)
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2025-04-23
- FDA classified
- 2025-05-06
- Posted by FDA
- 2025-05-14
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0404-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.