Recalls / Class II
Class IID-0551-2021
Product
Triamcinolone Acetonide Ointment, USP, 0.025% 80g; Rx Only, Distributed by: Perrigo, Allegan, MI 49010,NDC 45802-054-36
- Brand name
- Triamcinolone Acetonide
- Generic name
- Triamcinolone Acetonide
- Active ingredient
- Triamcinolone Acetonide
- Route
- Topical
- NDCs
- 45802-049, 45802-054, 45802-055
- FDA application
- ANDA087385
- Affected lot / code info
- 0MT0286
Why it was recalled
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Recalling firm
- Firm
- Cardinal Health Inc.
- Manufacturer
- Padagis Israel Pharmaceuticals Ltd
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 7000 Cardinal Pl, N/A, Dublin, Ohio 43017-1091
Distribution
- Quantity
- 178 tubes
- 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-0551-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.