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Recall Observatory FDA recall evidence

Drug 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.

D-0405-2025

April 23, 2025

Class II

Product summary

Firm
BRS Analytical Services, LLC
Event
Event 96741
Status
Ongoing
Classification
Class II
Quantity
1,610 cases (24 cartons per case)
Official record key
drug-enforcement:D-0405-2025

Official wording

Reason: cGMP deviations and lack of assurance of sterility.

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

Distribution pattern: Nationwide in the USA

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    cGMP deviations
  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    lack of assurance of sterility