BRS Analytical Services, LLC: Drug Recall

Recall #D-0407-2025 · 04/23/2025

Class II: Risk

Recall Details

Recall Number: D-0407-2025
Classification: Class II
Product Type: Drug
Recalling Firm: BRS Analytical Services, LLC
Status: Ongoing
Date Initiated: 04/23/2025
Location: Saint Louis, MO, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 13,104 cases (24 cartons per case)

Reason for Recall

cGMP deviations and lack of assurance of sterility.

Product Description

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.

Distribution Pattern

Nationwide in the USA

Other Recalls by BRS Analytical Services, LLC

Class II: Risk 04/23/2025

cGMP deviations and lack of assurance of sterility.
Class II: Risk 04/23/2025

cGMP deviations and lack of assurance of sterility.
Class II: Risk 04/23/2025

cGMP deviations and lack of assurance of sterility.
Class II: Risk 04/23/2025

cGMP deviations and lack of assurance of sterility.

View all recalls by BRS Analytical Services, LLC →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.