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.
Reported: March 9, 2022 Initiated: February 15, 2022 #D-0632-2022
Product Description
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.
Reason for Recall
cGMP deviations
Details
- Recalling Firm
- Macleods Pharma Usa Inc
- Units Affected
- 3,672 bottles
- Distribution
- USA Nationwide
- Location
- Plainsboro, NJ
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Macleods Pharma Usa Inc. Units affected: 3,672 bottles.
Why was this product recalled? ▼
cGMP deviations
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on March 9, 2022. Severity: Moderate. Recall number: D-0632-2022.
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