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Recall Observatory FDA recall evidence

Drug product

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

D-1147-2023

August 11, 2023

Class II

Product summary

Firm
AVKARE LLC
Event
Event 92868
Status
Terminated
Classification
Class II
Quantity
35,184 cartons
Official record key
drug-enforcement:D-1147-2023

Official wording

Reason: Product mix-up: Cartons labeled Capsaicin Cream 0.025% may contain tubes of Sodium Fluoride 1.1% Prescription Dental Toothpaste

Code information: Lot # P22078; Exp. 11/30/2024

Distribution pattern: Affected product was distributed to nineteen (19) consignees within the united states.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Product mix-up: Cartons labeled Capsaicin Cream 0.025% may contain tubes of Sodium Fluoride 1.1% Prescription Dental Toothpaste