Recalls / Class II
Class IID-0407-2025
Product
Lubricant Eye Drops Solution, Polyethylene Glycol 400 0.4% Eye Lubricant, Propylene Glycol 0.3% Eye Lubricant, Lubricant Eye Drops, Moisturizing, Sterile, 0.5 FL OZ (15mL) per dropper bottle, Distributed by: AvKARE, Pulaski, TN 38478, NDC: 50268-126-15.
- Brand name
- Lubricant Eye Drops Solution
- Generic name
- Polyethylene Glycol 400 And Propylene Glycol
- Active ingredients
- Polyethylene Glycol 400, Propylene Glycol
- Route
- Ophthalmic
- NDC
- 50268-126
- FDA application
- M018
- Affected lot / code info
- Lot, expiry: Lot 117, exp 9/20/25; Lot 118, exp 9/25/25; Lot 119, exp 9/27/25; Lot 121, exp 10/05/25; Lot 161, exp 5/01/26; Lot 171, exp 6/18/26; Lot 172, exp 6/24/26; Lot 174, exp 7/01/26; Lot 175, exp 7/08/26; Lot 200, exp 11/05/26; Lot 201, exp 11/10/26; Lot 202, exp 11/13/26; Lot 203, exp 11/18/26; Lot 204, exp 11/21/26; Lot 205, exp 11/25/26; Lot 206, exp 12/02/26; Lot 219, exp 2/24/27; Lot 221, exp 3/02/27; Lot 222, exp 3/05/27.
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
- 13,104 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-0407-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.