Recalls / Class II
Class IID-0438-2021
Product
Eletriptan Hydrobromide Tablets 20 mg* 6(1x6) Unit-dose Tablets Rx only NDC 59651-104-69 Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Highstown Road East Windsor, NJ 08520
- Brand name
- Eletriptan Hydrobromide
- Generic name
- Eletriptan Hydrobromide
- Active ingredient
- Eletriptan Hydrobromide
- Route
- Oral
- NDCs
- 59651-104, 59651-105
- FDA application
- ANDA210708
- Affected lot / code info
- EA2020001-A
Why it was recalled
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Recalling firm
- Firm
- Cardinal Health Inc.
- Manufacturer
- Aurobindo Pharma Limited
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 7000 Cardinal Pl, N/A, Dublin, Ohio 43017-1091
Distribution
- Quantity
- 20 CARTONS
- 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-0438-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.