February 21, 2020
Citing defective bottles that may not seal appropriately and protect from moisture, Pfizer Inc. is recalling two lots of Caduet (amlodipine besylate/atorvastatin calcium) tablets. The recall was announced in the February 19, 2020, US Food and Drug Administration (FDA) Enforcement Report.
The recall affects the following products, which were distributed throughout the United States:
- Caduet (amlodipine besylate/atorvastatin calcium) tablets, 10 mg/20 mg, 30-count bottles (NDC 0069-2180-30) from lot CY0937 (Exp. 12/21), and
- Caduet (amlodipine besylate/atorvastatin calcium) tablets, 10 mg/10 mg, 30-count bottles (NDC 0069-2160-30) from lot CY0963 (Exp. 7/22).
Pfizer voluntarily initiated the recall February 5, 2020. On February 13, 2020, the FDA designated the recall Class II. Drugs affected by Class II recalls may cause temporary or medically reversible adverse health consequences if used. While remote, a possibility of serious harm also exists.
Available with a prescription, Caduet is a combination statin and antihypertensive drug used to treat high blood pressure or chest pain as well as lower cholesterol.