Drug Enforcement D-0405-2025

cGMP deviations and lack of assurance of sterility.

Status

Ongoing

Classification

Class II

Report Date

May 14, 2025

Termination Date

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Product Information

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.
Product quantity
1,610 cases (24 cartons per case)
Reason for recall
cGMP deviations and lack of assurance of sterility.
Recall initiation reason
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Initial firm notification
Letter
Distribution pattern
Nationwide in the USA

Location & Firm

Recalling firm
BRS Analytical Services, LLC
Address
11697 Lakeside Crossing Ct, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
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Codes & Dates

Recall number
D-0405-2025
Event ID
96741
Recall initiation date
April 23, 2025
Center classification date
May 6, 2025
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
More code info
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