Recalls / Class II
Class IID-0180-2024
Product
ESTRADIOL TABLETS USP, 0.5MG 100 Tablets, Tx Only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454. NDC: 0555-0899-02
- Brand name
- Estradiol
- Generic name
- Estradiol
- Active ingredient
- Estradiol
- Route
- Oral
- NDCs
- 0555-0886, 0555-0899, 0555-0887
- FDA application
- ANDA040197
- Affected lot / code info
- Batch 100023687
Why it was recalled
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Recalling firm
- Firm
- CARDINAL HEALTHCARE
- Manufacturer
- Teva Pharmaceuticals USA, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 7200 Cardinal Pl W, Dublin, Ohio 43017-1094
Distribution
- Quantity
- 1 unit
- Distribution pattern
- Nationwide USA
Timeline
- Recall initiated
- 2022-01-26
- FDA classified
- 2023-12-26
- Posted by FDA
- 2024-01-03
- Terminated
- 2024-09-29
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0180-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.