← FDA ENFORCEMENT
D-1147-2023Class II

AVKARE LLC

Recalling firm
AVKARE LLC
Product type
Drug
Status
Terminated
Report date
2023-09-13
Distribution
Affected product was distributed to nineteen (19) consignees within the united states.
Firm state
TN
Product quantity
35,184 cartons
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Documentation & Change Control
Reason for recall

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

Product 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

Code / lot info

Lot # P22078; Exp. 11/30/2024

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Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.