Recalls / Class II
Class IID-0632-2022
Product
Amlodipine and Olmesartan Medoxomil Tablets, 10 mg /20 mg, 30-count bottles, Rx only, Manufactured for: Macleods Pharma USA, Inc., Plainsboro, NJ 08536, Manufactured by: Macleods Pharmaceuticals, Ltd, Baddi, Himachal Pradesh, INDIA, NDC 33342-192-07.
- 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
- Lot#: BAD62101A, Exp 2/2024
Why it was recalled
cGMP deviations
Recalling firm
- Firm
- Macleods Pharma Usa Inc
- Manufacturer
- Macleods Pharmaceuticals Limited
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 666 Plainsboro Rd Bldg 200 Ste 230, Plainsboro, New Jersey 08536-0009
Distribution
- Quantity
- 3,672 bottles
- Distribution pattern
- USA Nationwide
Timeline
- Recall initiated
- 2022-02-15
- FDA classified
- 2022-02-25
- Posted by FDA
- 2022-03-09
- Terminated
- 2023-02-17
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0632-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.