Home / Recalls / BRS Analytical Services, LLC / D-0405-2025

D-0405-2025 Class II Ongoing

Recalled by BRS Analytical Services, LLC — Saint Louis, MO

Recall Details

Product Type
Drugs
Report Date
May 14, 2025
Initiation Date
April 23, 2025
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1,610 cases (24 cartons per case)

Product Description

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.

Reason for Recall

cGMP deviations and lack of assurance of sterility.

Distribution Pattern

Nationwide in the USA

Code Information

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

Other recalls by BRS Analytical Services, LLC

  • D-0408-2025 Class II — Polyvinyl Alcohol Ophthalmic Solution 1.4%, Lubricant Eye Drops, Moisturizing, S (April 23, 2025)
  • D-0404-2025 Class II — Artificial Tears Ophthalmic Solution, Dextran 70.01%/Glycerin 0.2%/Hypromellose (April 23, 2025)
  • D-0406-2025 Class II — Carboxymethylcellulose Sodium Ophthalmic Solution 0.5%, Carboxymethlycellulose S (April 23, 2025)
  • D-0407-2025 Class II — Lubricant Eye Drops Solution, Polyethylene Glycol 400 0.4% Eye Lubricant, Propyl (April 23, 2025)