Multi-event February 2020 FDA Recall Caduet by Pfizer Inc.
This Multi-event Class II drug recall was voluntarily initiated by Pfizer Inc. on February 5, 2020 for the product Caduet. The FDA reported the reason for recall as defective container. The product was distributed Nationwide and the recall is currently terminated.
Reported Recall Events
Recall Number: D-0841-2020
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.
02-05-2020
02-19-2020
141 bottles
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Pfizer Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide in the USA.
03-08-2021
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
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
Recall Number: D-0842-2020
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.
02-05-2020
02-19-2020
128 bottles
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Pfizer Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide in the USA.
03-08-2021
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
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
