Caduet
FDA Recall NDC 0069-2180
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.
The FDA has identified 2 recorded enforcement report(s) associated with Caduet (NDC 0069-2180). A significant event, classified as Class II, was initiated on Feb 05, 2020 by Pfizer Laboratories Div Pfizer Inc. The reported reason for this action was: "Defective Container: products potentially could have been packaged in defective bottles, with a notched rim, that could cause inadequate foil sealing resulting in lack of moisture protection."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
Defective Container: products potentially could have been packaged in defective bottles, with a notched rim, that could cause inadequate foil sealing resulting in lack of moisture protection.
Feb 05, 2020
Feb 19, 2020
141 bottles
Recall Profile & Regulatory Data
Event ID
84860
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Pfizer Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA.
Termination Date
Mar 08, 2021
Product Description
Caduet (amlodipine besylate/atorvastatin calcium) Tablets, 10 mg/20 mg*, 30-count bottle, Rx only, Distributed by: Pfizer Labs, Division of Pfizer Inc. NY, NY 10017, Made in Germany, NDC 0069-2180-30.
Batch or Lot Expiration Information
Lot# : CY0937, Exp 12/2021
Affected Packages Involved in this Recall
0069-2150-30Product
0069-2170-30Product
0069-2190-30Product
0069-2260-30Product
0069-2160-30Product
0069-2180-30Product
0069-2250-30Product
0069-2270-30Product
0069-6180-30Product
0069-6323-30Product
0069-6565-30Product
0069-6747-30Product
0069-7810-30Product
0069-7232-30Product
0069-7654-30Product
0069-7476-30Product
Class II Terminated
Defective Container: products potentially could have been packaged in defective bottles, with a notched rim, that could cause inadequate foil sealing resulting in lack of moisture protection.
Feb 05, 2020
Feb 19, 2020
128 bottles
Recall Profile & Regulatory Data
Event ID
84860
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Pfizer Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA.
Termination Date
Mar 08, 2021
Product Description
Caduet (amlodipine besylate/atorvastatin calcium) Tablets, 10 mg/10 mg*, 30-count bottle, Rx only, Distributed by: Pfizer Labs, Division of Pfizer Inc. NY, NY 10017, Made in Germany, NDC 0069-2160-30.
Batch or Lot Expiration Information
Lot# : CY0963, Exp 07/2022
Affected Packages Involved in this Recall
0069-2150-30Product
0069-2170-30Product
0069-2190-30Product
0069-2260-30Product
0069-2160-30Product
0069-2180-30Product
0069-2250-30Product
0069-2270-30Product
0069-6180-30Product
0069-6323-30Product
0069-6565-30Product
0069-6747-30Product
0069-7810-30Product
0069-7232-30Product
0069-7654-30Product
0069-7476-30Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
