Recall Enforment Report D-1144-2015

Recall Details

Multi event Drug Recall Enforcement Report Class III voluntary initiated by Dr. Reddy's Laboratories, Inc., originally initiated on 05-06-2015 for the product Amlodipine besylate and Atorvastatin calcium tablets, 10mg/10mg, packaged in a)30-count bottle (NDC 43598-321-30), b) 90-count bottle (NDC 43598-321-90), Rx Only, Manufactured by Dr. Reddy's Laboratories Limited Bachupally, 500 090 India The product was recalled due to subpotent drug. The product was distributed nationwide and the recall is currently terminated.

Recall Enforcement Reports

Recall Number	Recall Initiation Date	Report Date	Recall Classification	Product Description	Recall Reason	Status
D-1144-2015	05-06-2015	06-24-2015	Class III	Amlodipine besylate and Atorvastatin calcium tablets, 10mg/10mg, packaged in a)30-count bottle (NDC 43598-321-30), b) 90-count bottle (NDC 43598-321-90), Rx Only, Manufactured by Dr. Reddy's Laboratories Limited Bachupally, 500 090 India	Subpotent drug	Terminated
D-1146-2015	05-06-2015	06-24-2015	Class III	Amlodipine besylate and Atorvastatin calcium tablets, 5mg/40mg packaged in a)30-count bottle (NDC 43598-316-30), b) 90-count bottle (NDC 43598-316-90), Rx Only, Manufactured by Dr. Reddy's Laboratories Limited Bachupally, 500 090 India	Subpotent drug	Terminated
D-1145-2015	05-06-2015	06-24-2015	Class III	Amlodipine besylate and Atorvastatin calcium tablets, 10mg/40mg, 90-count bottle, Rx Only Manufactured by Dr. Reddy's Laboratories Limited Bachupally, 500 090 India, NDC 43598-315-90	Subpotent drug	Terminated
D-1143-2015	05-06-2015	06-24-2015	Class III	Amlodipine besylate and Atorvastatin calcium tablets, 5mg/10mg, packaged in a)30-count bottle (NDC 43598-322-30), b) 90-count bottle (NDC 43598-322-90), Rx Only, Manufactured by Dr. Reddy's Laboratories Limited Bachupally, 500 090 India	Subpotent drug	Terminated

Recalled Products

NDC	Proprietary Name	Non-Proprietary Name	Dosage Form	Route Name	Company Name	Product Type
43598-313	Amlodipine Besylate And Atorvastatin Calcium	Amlodipine Besylate And Atorvastatin Calcium	Tablet, Film Coated	Oral	Dr. Reddy's Laboratories Inc	Human Prescription Drug
43598-314	Amlodipine Besylate And Atorvastatin Calcium	Amlodipine Besylate And Atorvastatin Calcium	Tablet, Film Coated	Oral	Dr. Reddy's Laboratories Inc	Human Prescription Drug
43598-315	Amlodipine Besylate And Atorvastatin Calcium	Amlodipine Besylate And Atorvastatin Calcium	Tablet, Film Coated	Oral	Dr. Reddy's Laboratories Inc	Human Prescription Drug
43598-316	Amlodipine Besylate And Atorvastatin Calcium	Amlodipine Besylate And Atorvastatin Calcium	Tablet, Film Coated	Oral	Dr. Reddy's Laboratories Inc	Human Prescription Drug
43598-317	Amlodipine Besylate And Atorvastatin Calcium	Amlodipine Besylate And Atorvastatin Calcium	Tablet, Film Coated	Oral	Dr. Reddy's Laboratories Inc	Human Prescription Drug
43598-318	Amlodipine Besylate And Atorvastatin Calcium	Amlodipine Besylate And Atorvastatin Calcium	Tablet, Film Coated	Oral	Dr. Reddy's Laboratories Inc	Human Prescription Drug
43598-319	Amlodipine Besylate And Atorvastatin Calcium	Amlodipine Besylate And Atorvastatin Calcium	Tablet, Film Coated	Oral	Dr. Reddy's Laboratories Inc	Human Prescription Drug
43598-320	Amlodipine Besylate And Atorvastatin Calcium	Amlodipine Besylate And Atorvastatin Calcium	Tablet, Film Coated	Oral	Dr. Reddy's Laboratories Inc	Human Prescription Drug
43598-321	Amlodipine Besylate And Atorvastatin Calcium	Amlodipine Besylate And Atorvastatin Calcium	Tablet, Film Coated	Oral	Dr. Reddy's Laboratories Inc	Human Prescription Drug
43598-322	Amlodipine Besylate And Atorvastatin Calcium	Amlodipine Besylate And Atorvastatin Calcium	Tablet, Film Coated	Oral	Dr. Reddy's Laboratories Inc	Human Prescription Drug
43598-323	Amlodipine Besylate And Atorvastatin Calcium	Amlodipine Besylate And Atorvastatin Calcium	Tablet, Film Coated	Oral	Dr. Reddy's Laboratories Inc	Human Prescription Drug

Field Name	Field Value
Event ID	71375 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-1144-2015 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).
Recall Classification	Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences. 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 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	Amlodipine besylate and Atorvastatin calcium tablets, 10mg/10mg, packaged in a)30-count bottle (NDC 43598-321-30), b) 90-count bottle (NDC 43598-321-90), Rx Only, Manufactured by Dr. Reddy's Laboratories Limited Bachupally, 500 090 India
Reason For Recall	Subpotent drug What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	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	06-24-2015
Recall Initiation Date	05-06-2015 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Termination Date	03-31-2016 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	Dr. Reddy's Laboratories, Inc.
Code Info	Lot #: a) C401537, Exp 07/2015; b) C401539, Exp 07/2015 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	43598-323-30; 43598-323-60; 43598-323-90; 43598-323-05; 43598-320-30; 43598-320-60; 43598-320-90; 43598-320-05; 43598-317-30; 43598-317-60; 43598-317-90; 43598-317-05; 43598-322-30; 43598-322-60; 43598-322-90; 43598-322-05; 43598-319-30; 43598-319-60; 43598-319-90; 43598-319-05; 43598-316-30; 43598-316-60; 43598-316-90; 43598-316-05; 43598-314-30; 43598-314-60; 43598-314-90; 43598-314-05; 43598-321-30; 43598-321-60; 43598-321-90; 43598-321-05; 43598-318-30; 43598-318-60; 43598-318-90; 43598-318-05; 43598-315-30; 43598-315-60; 43598-315-90; 43598-315-05; 43598-313-30; 43598-313-60; 43598-313-90; 43598-313-05
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	71375 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-1146-2015 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).
Recall Classification	Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences. 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 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	Amlodipine besylate and Atorvastatin calcium tablets, 5mg/40mg packaged in a)30-count bottle (NDC 43598-316-30), b) 90-count bottle (NDC 43598-316-90), Rx Only, Manufactured by Dr. Reddy's Laboratories Limited Bachupally, 500 090 India
Reason For Recall	Subpotent drug What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	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	06-24-2015
Recall Initiation Date	05-06-2015 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Termination Date	03-31-2016 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	Dr. Reddy's Laboratories, Inc.
Code Info	Lot # C402439 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	43598-323-30; 43598-323-60; 43598-323-90; 43598-323-05; 43598-320-30; 43598-320-60; 43598-320-90; 43598-320-05; 43598-317-30; 43598-317-60; 43598-317-90; 43598-317-05; 43598-322-30; 43598-322-60; 43598-322-90; 43598-322-05; 43598-319-30; 43598-319-60; 43598-319-90; 43598-319-05; 43598-316-30; 43598-316-60; 43598-316-90; 43598-316-05; 43598-314-30; 43598-314-60; 43598-314-90; 43598-314-05; 43598-321-30; 43598-321-60; 43598-321-90; 43598-321-05; 43598-318-30; 43598-318-60; 43598-318-90; 43598-318-05; 43598-315-30; 43598-315-60; 43598-315-90; 43598-315-05; 43598-313-30; 43598-313-60; 43598-313-90; 43598-313-05
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	71375 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-1145-2015 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).
Recall Classification	Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences. 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 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	Amlodipine besylate and Atorvastatin calcium tablets, 10mg/40mg, 90-count bottle, Rx Only Manufactured by Dr. Reddy's Laboratories Limited Bachupally, 500 090 India, NDC 43598-315-90
Reason For Recall	Subpotent drug What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	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	06-24-2015
Recall Initiation Date	05-06-2015 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Termination Date	03-31-2016 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	Dr. Reddy's Laboratories, Inc.
Code Info	Lot # C309280 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	43598-323-30; 43598-323-60; 43598-323-90; 43598-323-05; 43598-320-30; 43598-320-60; 43598-320-90; 43598-320-05; 43598-317-30; 43598-317-60; 43598-317-90; 43598-317-05; 43598-322-30; 43598-322-60; 43598-322-90; 43598-322-05; 43598-319-30; 43598-319-60; 43598-319-90; 43598-319-05; 43598-316-30; 43598-316-60; 43598-316-90; 43598-316-05; 43598-314-30; 43598-314-60; 43598-314-90; 43598-314-05; 43598-321-30; 43598-321-60; 43598-321-90; 43598-321-05; 43598-318-30; 43598-318-60; 43598-318-90; 43598-318-05; 43598-315-30; 43598-315-60; 43598-315-90; 43598-315-05; 43598-313-30; 43598-313-60; 43598-313-90; 43598-313-05
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	71375 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-1143-2015 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).
Recall Classification	Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences. 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 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	Amlodipine besylate and Atorvastatin calcium tablets, 5mg/10mg, packaged in a)30-count bottle (NDC 43598-322-30), b) 90-count bottle (NDC 43598-322-90), Rx Only, Manufactured by Dr. Reddy's Laboratories Limited Bachupally, 500 090 India
Reason For Recall	Subpotent drug What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	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	06-24-2015
Recall Initiation Date	05-06-2015 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Termination Date	03-31-2016 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	Dr. Reddy's Laboratories, Inc.
Code Info	Lot #: a) C401536, Exp 07/2015; b) C401538, Exp 07/2015 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	43598-323-30; 43598-323-60; 43598-323-90; 43598-323-05; 43598-320-30; 43598-320-60; 43598-320-90; 43598-320-05; 43598-317-30; 43598-317-60; 43598-317-90; 43598-317-05; 43598-322-30; 43598-322-60; 43598-322-90; 43598-322-05; 43598-319-30; 43598-319-60; 43598-319-90; 43598-319-05; 43598-316-30; 43598-316-60; 43598-316-90; 43598-316-05; 43598-314-30; 43598-314-60; 43598-314-90; 43598-314-05; 43598-321-30; 43598-321-60; 43598-321-90; 43598-321-05; 43598-318-30; 43598-318-60; 43598-318-90; 43598-318-05; 43598-315-30; 43598-315-60; 43598-315-90; 43598-315-05; 43598-313-30; 43598-313-60; 43598-313-90; 43598-313-05
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.