Recalls / Class II
Class IID-0509-2021
Product
Amlodipine and Olmesartan Medoxomil Tablets 10 mg/20 mg 30 Tablets Rx Only NDC 33342-192-07 Manufactured for: Macleods Pharma USA, Inc. Plainsboro, NJ 08536 Manufactured by: Macleods Pharmaceuticals Ltd. Baddi, Himachal Pradesh, India
- Brand name
- Amlodipine And Olmesartan Medoxomil
- Generic name
- Amlodipine And Olmesartan Medoxomil
- Active ingredients
- Amlodipine Besylate, Olmesartan Medoxomil
- Route
- Oral
- NDCs
- 33342-190, 33342-191, 33342-192, 33342-193
- FDA application
- ANDA206884
- Affected lot / code info
- BAD62005A
Why it was recalled
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Recalling firm
- Firm
- Cardinal Health Inc.
- Manufacturer
- Macleods Pharmaceuticals Limited
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 7000 Cardinal Pl, N/A, Dublin, Ohio 43017-1091
Distribution
- Quantity
- 33 bottles
- 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-0509-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.