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Recall Observatory FDA recall evidence

Drug product

Artificial Tears Ophthalmic Solution, Dextran 70.01%/Glycerin 0.2%/Hypromellose 0.3% (Eye Lubricants) Lubricant Eye Drops, STERILE, 0.5 FL OZ (15 mL) per dropper bottle, Distributed by: AvKARE, Pulaski, TN 38478, NDC: 50268-043-15.

D-0404-2025

April 23, 2025

Class II

Product summary

Firm
BRS Analytical Services, LLC
Event
Event 96741
Status
Ongoing
Classification
Class II
Quantity
13,872 cases (24 cartons per case)
Official record key
drug-enforcement:D-0404-2025

Official wording

Reason: cGMP deviations and lack of assurance of sterility.

Code information: Lot, expiry: Lot 126, exp 10/26/25; Lot 127, exp 10/30/25; Lot 128, exp 11/02/25; Lot 129, exp 11/06/25; Lot 162, exp 5/09/26; Lot 163, exp 5/14/26; Lot 164, exp 5/20/26; Lot 165, exp 5/23/26; Lot 166, exp 5/29/26; Lot 167, exp 6/03/26; Lot 168, exp 6/06/26; Lot 169, exp 6/10/26; Lot 170, exp 6/13/26; Lot 193, exp 10/07/26; Lot 194, exp 10/10/26; Lot 195, exp 10/14/26; Lot 196, exp 10/17/26; Lot 197, exp 10/21/26; Lot 198, exp 10/24/26; Lot 199, exp 10/30/26.

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