Recalls / Class II
Class IID-0437-2021
Product
IBUPROFEN ORAL SUSPENSION USP 100MG/5ML 120ML ; NDC/UPC 59651-032-12; RX; SUSPENSION (NO DROPS)
- Brand name
- Ibuprofen
- Generic name
- Ibuprofen Oral
- Active ingredient
- Ibuprofen
- Route
- Oral
- NDC
- 59651-032
- FDA application
- ANDA209178
- Affected lot / code info
- BO1020069-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
- 345 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-0437-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.