Recall Enforment Report D-0841-2020

Recall Details

Multi event Drug Recall Enforcement Report Class II voluntary initiated by Pfizer Inc., originally initiated on 02-05-2020 for 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. The product was recalled due to 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.. The product was distributed nationwide and the recall is currently terminated.

Recall Enforcement Reports

Recall Number	Recall Initiation Date	Report Date	Recall Classification	Quantity	Product Description	Recall Reason	Status
D-0841-2020	02-05-2020	02-19-2020	Class II	141 bottles	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.	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.	Terminated
D-0842-2020	02-05-2020	02-19-2020	Class II	128 bottles	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.	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.	Terminated

Recalled Products

NDC	Proprietary Name	Non-Proprietary Name	Dosage Form	Route Name	Company Name	Product Type
0069-2150	Caduet				Pfizer Laboratories Div Pfizer Inc
0069-2160	Caduet				Pfizer Laboratories Div Pfizer Inc
0069-2170	Caduet				Pfizer Laboratories Div Pfizer Inc
0069-2180	Caduet				Pfizer Laboratories Div Pfizer Inc
0069-2190	Caduet				Pfizer Laboratories Div Pfizer Inc
0069-2250	Caduet				Pfizer Laboratories Div Pfizer Inc
0069-2260	Caduet	Amlodipine Besylate And Atorvastatin Calcium	Tablet, Film Coated	Oral	Pfizer Laboratories Div Pfizer Inc	Human Prescription Drug
0069-2270	Caduet				Pfizer Laboratories Div Pfizer Inc
0069-6180	Caduet	Amlodipine And Atorvastatin	Tablet, Film Coated	Oral	Pfizer Laboratories Div Pfizer Inc	Human Prescription Drug
0069-6323	Caduet	Amlodipine And Atorvastatin	Tablet, Film Coated	Oral	Pfizer Laboratories Div Pfizer Inc	Human Prescription Drug
0069-6565	Caduet	Amlodipine And Atorvastatin	Tablet, Film Coated	Oral	Pfizer Laboratories Div Pfizer Inc	Human Prescription Drug
0069-6747	Caduet	Amlodipine And Atorvastatin	Tablet, Film Coated	Oral	Pfizer Laboratories Div Pfizer Inc	Human Prescription Drug
0069-7232	Caduet	Amlodipine And Atorvastatin	Tablet, Film Coated	Oral	Pfizer Laboratories Div Pfizer Inc	Human Prescription Drug
0069-7476	Caduet	Amlodipine And Atorvastatin	Tablet, Film Coated	Oral	Pfizer Laboratories Div Pfizer Inc	Human Prescription Drug
0069-7654	Caduet	Amlodipine And Atorvastatin	Tablet, Film Coated	Oral	Pfizer Laboratories Div Pfizer Inc	Human Prescription Drug
0069-7810	Caduet	Amlodipine And Atorvastatin	Tablet, Film Coated	Oral	Pfizer Laboratories Div Pfizer Inc	Human Prescription Drug

Field Name	Field Value
Event ID	84860 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-0841-2020 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).
Recall Classification	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 What is the Recall Classification? Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified".
Distribution Pattern	Nationwide in the USA. What is the Distribution Pattern? General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included.
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.
Reason For Recall	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. What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	141 bottles Product Quantity The amount of product subject to recall.
Voluntary Mandated	Voluntary: Firm initiated Voluntary / Mandated Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order.
Report Date	02-19-2020
Recall Initiation Date	02-05-2020 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Termination Date	03-08-2021 What is the Date Terminated? The date that FDA terminated the recall.
Initial Firm Notification	Letter Initial Firm Notification of Consignee or Public The method(s) by which the firm initially notified the public or their consignees of a recall.
Product Type	Drugs
Recalling Firm	Pfizer Inc.
Code Info	Lot #: CY0937, Exp 12/2021 Code Information A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling.
Recalled NDC Packages	0069-2150-30; 0069-2170-30; 0069-2190-30; 0069-2260-30; 0069-2160-30; 0069-2180-30; 0069-2250-30; 0069-2270-30; 0069-6180-30; 0069-6323-30; 0069-6565-30; 0069-6747-30; 0069-7810-30; 0069-7232-30; 0069-7654-30; 0069-7476-30
Status	Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.

Field Name	Field Value
Event ID	84860 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-0842-2020 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).
Recall Classification	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 What is the Recall Classification? Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified".
Distribution Pattern	Nationwide in the USA. What is the Distribution Pattern? General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included.
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.
Reason For Recall	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. What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	128 bottles Product Quantity The amount of product subject to recall.
Voluntary Mandated	Voluntary: Firm initiated Voluntary / Mandated Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order.
Report Date	02-19-2020
Recall Initiation Date	02-05-2020 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Termination Date	03-08-2021 What is the Date Terminated? The date that FDA terminated the recall.
Initial Firm Notification	Letter Initial Firm Notification of Consignee or Public The method(s) by which the firm initially notified the public or their consignees of a recall.
Product Type	Drugs
Recalling Firm	Pfizer Inc.
Code Info	Lot #: CY0963, Exp 07/2022 Code Information A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling.
Recalled NDC Packages	0069-2150-30; 0069-2170-30; 0069-2190-30; 0069-2260-30; 0069-2160-30; 0069-2180-30; 0069-2250-30; 0069-2270-30; 0069-6180-30; 0069-6323-30; 0069-6565-30; 0069-6747-30; 0069-7810-30; 0069-7232-30; 0069-7654-30; 0069-7476-30
Status	Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.