Recalls / Class II
Class IID-0408-2025
Product
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.
- Brand name
- Polyvinyl Alcohol
- Generic name
- Polyvinyl Alcohol
- Active ingredient
- Polyvinyl Alcohol
- Route
- Ophthalmic
- NDC
- 50268-678
- FDA application
- M018
- Affected lot / code info
- Lot, expiry: Lot 120, exp 10/02/25; Lot 122, exp 10/09/25; Lot 123, exp 10/12/25; Lot 124, exp 10/16/25; Lot 138, exp 1/08/26; Lot 142, exp 1/29/26; Lot 143, exp 2/01/26; Lot 144, exp 2/07/26; Lot 145, exp 2/12/26; Lot 146, exp 2/15/26; Lot 147, exp 2/21/26; Lot 148, exp 2/27/26; Lot 149, exp 3/04/26; Lot 150, exp 3/11/26; Lot 158, exp 4/15/26; Lot 159, exp 4/22/26; Lot 176, exp 7/24/26; Lot 177, exp 7/28/26; Lot 178, exp 7/31/26; Lot 179, exp 8/05/26.
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
- 14,333 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-0408-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.