D-1147-2023 Class II Terminated
FDA drug recall D-1147-2023 was initiated by AVKARE LLC on August 11, 2023 and is designated Class II. Reason for recall: Product mix-up: Cartons labeled Capsaicin Cream 0.025% may contain tubes of Sodium Fluoride 1.1% Prescription Dental Toothpaste The recall status is terminated (terminated April 29, 2024). Affected quantity: 35,184 cartons.
Recall Details
- Product Type
- Drugs
- Report Date
- September 13, 2023
- Initiation Date
- August 11, 2023
- Termination Date
- April 29, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 35,184 cartons
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
Reason for Recall
Product mix-up: Cartons labeled Capsaicin Cream 0.025% may contain tubes of Sodium Fluoride 1.1% Prescription Dental Toothpaste
Distribution Pattern
Affected product was distributed to nineteen (19) consignees within the united states.
Code Information
Lot # P22078; Exp. 11/30/2024