Recalls / Class II
Class IID-0517-2021
Product
DIBUCAINE TOPICAL ANESTHETIC 1% HEMORRHOIDAL OINTMENT 28GM ; NDC/UPC 0536-1211-95; OTC; OINTMENT
- Brand name
- Dibucaine Topical Anesthetic 1% Hemorrhoidal
- Generic name
- Dibucaine
- Active ingredient
- Dibucaine
- Route
- Topical
- NDC
- 0536-1211
- FDA application
- M015
- Affected lot / code info
- All Lots distributed 02/23/2021 through 03/10/2021.
Why it was recalled
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Recalling firm
- Firm
- Cardinal Health Inc.
- Manufacturer
- Rugby Laboratories Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 7000 Cardinal Pl, N/A, Dublin, Ohio 43017-1091
Distribution
- Quantity
- 701 CARTON
- Distribution pattern
- FL, GA, SC
Timeline
- Recall initiated
- 2021-03-15
- FDA classified
- 2021-05-24
- Posted by FDA
- 2021-06-02
- Terminated
- 2024-06-17
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0517-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.