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CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM Recall D-0175-2025

Description: Carboxymethylcellulose Sodium Ophthalmic Solution 0.5% Moisturizing Lubricant Eye Drops, 0.5 FL OZ (15 mL) bottles, Distributed by: AvKARE, Pulaski, TN, 38478, NDC 50268-068-15.

CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM Recall D-0175-2025 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-0175-2025
Event ID96032
BrandCARBOXYMETHYLCELLULOSE SODIUM
Generic NameCARBOXYMETHYLCELLULOSE SODIUM
ManufacturerCARBOXYMETHYLCELLULOSE SODIUM
Original Package?1
Active SubstanceCARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM
Drug RouteOPHTHALMIC
DistributionNationwide within the United States
Quantity16,677 cartons
Recall ReasonLABELING: LABEL MIX-UP
Drug ClassificationClass III
Drug Code Info20250108
Product NDC50268-068
Recall Initiation Date20241218
Report Date20250108
Classification Date20250102
Address615 N 1st St
Pulaski, TN 38478-2403
United States
Recalling FirmAvKARE
Initial Notification Letter
Unique Ingredient IdentifierK679OBS311
Drug Application NumberM018
Structured Product Labeling (SPL ID)1fbe6d77-9d64-f4c3-e063-6394a90a31e6
Structured Product Labeling (SPL Set ID)b479d2ae-4b59-916a-e053-2995a90af8ec
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