Recalls / Class II
Class IID-1147-2023
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
- Brand name
- Capsaicin
- Generic name
- Capsaicin
- Active ingredient
- Capsaicin
- Route
- Topical
- NDC
- 50268-195
- FDA application
- M017
- Affected lot / code info
- Lot # P22078; Exp. 11/30/2024
Why it was recalled
Product mix-up: Cartons labeled Capsaicin Cream 0.025% may contain tubes of Sodium Fluoride 1.1% Prescription Dental Toothpaste
Recalling firm
- Firm
- AVKARE LLC
- Manufacturer
- AvPAK
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 615 N 1st St, N/A, Pulaski, Tennessee 38478-2403
Distribution
- Quantity
- 35,184 cartons
- Distribution pattern
- Affected product was distributed to nineteen (19) consignees within the united states.
Timeline
- Recall initiated
- 2023-08-11
- FDA classified
- 2023-09-07
- Posted by FDA
- 2023-09-13
- Terminated
- 2024-04-29
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1147-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.