Product Safety Recalls

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CAPSAICIN Recall D-1147-2023

Description: Capsaicin Cream 0.025%, External Analgesic Cream, Penetrating Pain Relief, NET WT. 2.1 OZ. (60g) NDC 50268-195-60, Manufactured for: AvKARE, Pulaski, TN 38478

CAPSAICIN Recall D-1147-2023 Information

Mandated?Voluntary: Firm initiated
Recall NumberD-1147-2023
Event ID92868
Original Package?1
Active SubstanceCAPSAICIN
DistributionAffected product was distributed to nineteen (19) consignees within the united states.
Quantity35,184 cartons
Recall ReasonProduct mix-up: Cartons labeled Capsaicin Cream 0.025% may contain tubes of Sodium Fluoride 1.1% Prescription Dental Toothpaste
Drug ClassificationClass II
Drug Code Info20230913
Product NDC50268-195
Recall Initiation Date20230811
Report Date20230913
Classification Date20230907
Address615 N 1st St
Pulaski, TN 38478-2403
United States
Recalling FirmAVKARE LLC
Initial Notification Letter
Unique Ingredient IdentifierS07O44R1ZM
Drug Application Numberpart348
Structured Product Labeling (SPL ID)ef5a4143-6e96-80c8-e053-2a95a90a6565
Structured Product Labeling (SPL Set ID)ef5a3846-1d2f-7023-e053-2a95a90ad716
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