Drug recall D-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
Reason for recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Lots and codes
BAD62005A
Recall details
- Recalling firm
- Cardinal Health Inc., Dublin, OH
- Quantity
- 33 bottles
- Distribution
- FL, GA, SC
- Type
- Voluntary: Firm initiated
- Recall initiated
- March 15, 2021
- Terminated
- June 17, 2024
Related products
- Amlodipine and Olmesartan Medoxomil – drug information
- NDC 33342-193 AMLODIPINE and OLMESARTAN medoxomil · Amlodipine Besylate 10 mg/1; Olmesartan Medoxomil 40 mg/1 · Macleods Pharmaceuticals Limited
- NDC 33342-190 AMLODIPINE and OLMESARTAN medoxomil · Amlodipine Besylate 5 mg/1; Olmesartan Medoxomil 20 mg/1 · Macleods Pharmaceuticals Limited
- NDC 33342-192 AMLODIPINE and OLMESARTAN medoxomil · Amlodipine Besylate 10 mg/1; Olmesartan Medoxomil 20 mg/1 · Macleods Pharmaceuticals Limited
- NDC 33342-191 AMLODIPINE and OLMESARTAN medoxomil · Amlodipine Besylate 5 mg/1; Olmesartan Medoxomil 40 mg/1 · Macleods Pharmaceuticals Limited