Recalls / Class II

Class IID-0405-2025

Product

Carboxymethylcellulose Sodium Ophthalmic Gel 1%, Carboxymethlycellulose Sodium 1% Eye Lubricant, Lubricant Eye Gel, Soothing Gel, Sterile, 0.5 FL OZ (15mL) per bottle, Distributed by: AvKARE, Pulaski, TN 38478, NDC: 50268-066-15.

Affected lot / code info

Lot, expiry: Lot 114, exp 9/04/25; Lot 115, exp 9/06/25; Lot 116, exp 9/10/25; Lot 207, exp 12/05/26

Why it was recalled

cGMP deviations and lack of assurance of sterility.

Recalling firm

Firm

BRS Analytical Services, LLC

Notification channel

Letter

Type

Voluntary: Firm initiated

Address

11697 Lakeside Crossing Ct, N/A, Saint Louis, Missouri 63146-8606

Distribution

Quantity

1,610 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-0405-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.