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

FDA recall notice · announced September 13, 2023 · Avkare

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The 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

Notes

Distribution: Affected product was distributed to nineteen (19) consignees within the united states.
Lot/code information: Lot # P22078; Exp. 11/30/2024
Quantity: 35,184 cartons
Status: Terminated
Products in this recall event:
- Sodium Fluoride 1.1%, SODIUM FLUORIDE Prescription Dental Toothpaste, 5000 ppm Fluoride Plus Mild Cleaning System Spearmint NET WT. 1.8 OZ. (51g), Rx only, NDC 42291-741-51, Manufactured for: AvKARE P (D-1146-2023)
- 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)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.