FDA recall D-1147-2023

AVKARE LLC · Class II · 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

Reason for recall

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

Distribution

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

Key facts

Status
Terminated
Initiation date
2023-08-11
Report date
2023-09-13
Termination date
2024-04-29
Voluntary/Mandated
Voluntary: Firm initiated
Location
Pulaski, TN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1147-2023