Amlodipine Besylate And Atorvastatin Calcium Tablet, Film Coated
FDA Recall NDC 43598-321

FDA Enforcement Report: View Recall Date, Reasons, and Safety Status

Active & Historical Enforcement Reports

The FDA has identified 11 recorded enforcement report(s) associated with Amlodipine Besylate And Atorvastatin Calcium (NDC 43598-321). A significant event, classified as Class III, was initiated on Aug 13, 2015 by Dr. Reddy's Laboratories Inc. The reported reason for this action was: "Subpotent Drug: Subpotent atorvastatin."

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

D-1376-2015TERMINATEDD-1374-2015TERMINATEDD-1375-2015TERMINATEDD-1379-2015TERMINATEDD-1377-2015TERMINATEDD-1378-2015TERMINATEDD-1373-2015TERMINATEDD-1143-2015TERMINATEDD-1145-2015TERMINATEDD-1144-2015TERMINATEDD-1146-2015TERMINATED

August 2015 Class III Recall: Subpotent Drug

Recall Number
D-1376-2015
Class III Terminated
Reason for Recall
Subpotent Drug: Subpotent atorvastatin.
Initiated
Aug 13, 2015
Reported
Sep 02, 2015
Quantity
a) 14,640 and b) 624 Bottles

Recall Profile & Regulatory Data

Event ID
71984
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Dr. Reddy's Laboratories, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
U.S. Nationwide
Termination Date
Dec 15, 2016
Product Description
Amlodipine besylate and Atorvastatin calcium Tablets, 5 mg/20 mg, Packaged in a) 30 Count Bottles (NDC: 43598-319-30) and b) 90 Count Bottles (NDC: 43598-319-90), Rx Only. Manufactured by Dr. Reddy's Laboratories Limited, Bachupally - 500 090 India.
Batch or Lot Expiration Information
Lot# a)
Lot# : C403577, Expiry: 10/2015; b)
Lot# : C403577, Expiry: 10/2015.
Affected Packages Involved in this Recall
43598-323-30Product
43598-323-60Product
43598-323-90Product
43598-323-05Product
43598-320-30Product
43598-320-60Product
43598-320-90Product
43598-320-05Product
43598-317-30Product
43598-317-60Product
43598-317-90Product
43598-317-05Product
43598-322-30Product
43598-322-60Product
43598-322-90Product
43598-322-05Product
43598-319-30Product
43598-319-60Product
43598-319-90Product
43598-319-05Product
43598-316-30Product
43598-316-60Product
43598-316-90Product
43598-316-05Product
43598-314-30Product
43598-314-60Product
43598-314-90Product
43598-314-05Product
43598-321-30Product
43598-321-60Product
43598-321-90Product
43598-321-05Product
43598-318-30Product
43598-318-60Product
43598-318-90Product
43598-318-05Product
43598-315-30Product
43598-315-60Product
43598-315-90Product
43598-315-05Product
43598-313-30Product
43598-313-60Product
43598-313-90Product
43598-313-05Product

August 2015 Class III Recall: Subpotent Drug

Recall Number
D-1374-2015
Class III Terminated
Reason for Recall
Subpotent Drug: Subpotent atorvastatin.
Initiated
Aug 13, 2015
Reported
Sep 02, 2015
Quantity
576 Bottles

Recall Profile & Regulatory Data

Event ID
71984
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Dr. Reddy's Laboratories, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
U.S. Nationwide
Termination Date
Dec 15, 2016
Product Description
Amlodipine besylate and Atorvastatin calcium Tablets, 2.5 mg/20 mg, 30 Count Bottles, Rx Only. Manufactured by Dr. Reddy's Laboratories Limited, Bachupally - 500 090 India. NDC: 43598-320-30.
Batch or Lot Expiration Information
Lot# : C403574, Expiry: 10/2015
Affected Packages Involved in this Recall
43598-323-30Product
43598-323-60Product
43598-323-90Product
43598-323-05Product
43598-320-30Product
43598-320-60Product
43598-320-90Product
43598-320-05Product
43598-317-30Product
43598-317-60Product
43598-317-90Product
43598-317-05Product
43598-322-30Product
43598-322-60Product
43598-322-90Product
43598-322-05Product
43598-319-30Product
43598-319-60Product
43598-319-90Product
43598-319-05Product
43598-316-30Product
43598-316-60Product
43598-316-90Product
43598-316-05Product
43598-314-30Product
43598-314-60Product
43598-314-90Product
43598-314-05Product
43598-321-30Product
43598-321-60Product
43598-321-90Product
43598-321-05Product
43598-318-30Product
43598-318-60Product
43598-318-90Product
43598-318-05Product
43598-315-30Product
43598-315-60Product
43598-315-90Product
43598-315-05Product
43598-313-30Product
43598-313-60Product
43598-313-90Product
43598-313-05Product

August 2015 Class III Recall: Subpotent Drug

Recall Number
D-1375-2015
Class III Terminated
Reason for Recall
Subpotent Drug: Subpotent atorvastatin.
Initiated
Aug 13, 2015
Reported
Sep 02, 2015
Quantity
984 Bottles

Recall Profile & Regulatory Data

Event ID
71984
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Dr. Reddy's Laboratories, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
U.S. Nationwide
Termination Date
Dec 15, 2016
Product Description
Amlodipine besylate and Atorvastatin calcium Tablets,2.5 mg/40 mg, 30 Count Bottles, Rx Only. Manufactured by Dr. Reddy's Laboratories Limited, Bachupally - 500 090 India. NDC: 43598-317-30.
Batch or Lot Expiration Information
Lot# : C402341, Expiry: 08/2015
Affected Packages Involved in this Recall
43598-323-30Product
43598-323-60Product
43598-323-90Product
43598-323-05Product
43598-320-30Product
43598-320-60Product
43598-320-90Product
43598-320-05Product
43598-317-30Product
43598-317-60Product
43598-317-90Product
43598-317-05Product
43598-322-30Product
43598-322-60Product
43598-322-90Product
43598-322-05Product
43598-319-30Product
43598-319-60Product
43598-319-90Product
43598-319-05Product
43598-316-30Product
43598-316-60Product
43598-316-90Product
43598-316-05Product
43598-314-30Product
43598-314-60Product
43598-314-90Product
43598-314-05Product
43598-321-30Product
43598-321-60Product
43598-321-90Product
43598-321-05Product
43598-318-30Product
43598-318-60Product
43598-318-90Product
43598-318-05Product
43598-315-30Product
43598-315-60Product
43598-315-90Product
43598-315-05Product
43598-313-30Product
43598-313-60Product
43598-313-90Product
43598-313-05Product

August 2015 Class III Recall: Subpotent Drug

Recall Number
D-1379-2015
Class III Terminated
Reason for Recall
Subpotent Drug: Subpotent atorvastatin.
Initiated
Aug 13, 2015
Reported
Sep 02, 2015
Quantity
3840 Bottles

Recall Profile & Regulatory Data

Event ID
71984
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Dr. Reddy's Laboratories, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
U.S. Nationwide
Termination Date
Dec 15, 2016
Product Description
Amlodipine besylate and Atorvastatin calcium Tablets, 10 mg/80 mg, 30 Count Bottles, Rx Only. Manufactured by Dr. Reddy's Laboratories Limited, Bachupally - 500 090 India. NDC: 43598-313-30.
Batch or Lot Expiration Information
Lot# : C404595, Expiry: 11/2015
Affected Packages Involved in this Recall
43598-323-30Product
43598-323-60Product
43598-323-90Product
43598-323-05Product
43598-320-30Product
43598-320-60Product
43598-320-90Product
43598-320-05Product
43598-317-30Product
43598-317-60Product
43598-317-90Product
43598-317-05Product
43598-322-30Product
43598-322-60Product
43598-322-90Product
43598-322-05Product
43598-319-30Product
43598-319-60Product
43598-319-90Product
43598-319-05Product
43598-316-30Product
43598-316-60Product
43598-316-90Product
43598-316-05Product
43598-314-30Product
43598-314-60Product
43598-314-90Product
43598-314-05Product
43598-321-30Product
43598-321-60Product
43598-321-90Product
43598-321-05Product
43598-318-30Product
43598-318-60Product
43598-318-90Product
43598-318-05Product
43598-315-30Product
43598-315-60Product
43598-315-90Product
43598-315-05Product
43598-313-30Product
43598-313-60Product
43598-313-90Product
43598-313-05Product

August 2015 Class III Recall: Subpotent Drug

Recall Number
D-1377-2015
Class III Terminated
Reason for Recall
Subpotent Drug: Subpotent atorvastatin.
Initiated
Aug 13, 2015
Reported
Sep 02, 2015
Quantity
a) 16,080 and b) 480 Bottles

Recall Profile & Regulatory Data

Event ID
71984
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Dr. Reddy's Laboratories, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
U.S. Nationwide
Termination Date
Dec 15, 2016
Product Description
Amlodipine besylate and Atorvastatin calcium Tablets, 10 mg/20 mg, Packaged in a) 30 Count Bottles (NDC: 43598-318-30) and b) 90 Count Bottles (NDC: 43598-318-90), Rx Only. Manufactured by Dr. Reddy's Laboratories Limited, Bachupally - 500 090 India
Batch or Lot Expiration Information
Lot# a)
Lot# : C404592, Expiry: 11/2015. b)
Lot# : C404592, Expiry: 11/2015
Affected Packages Involved in this Recall
43598-323-30Product
43598-323-60Product
43598-323-90Product
43598-323-05Product
43598-320-30Product
43598-320-60Product
43598-320-90Product
43598-320-05Product
43598-317-30Product
43598-317-60Product
43598-317-90Product
43598-317-05Product
43598-322-30Product
43598-322-60Product
43598-322-90Product
43598-322-05Product
43598-319-30Product
43598-319-60Product
43598-319-90Product
43598-319-05Product
43598-316-30Product
43598-316-60Product
43598-316-90Product
43598-316-05Product
43598-314-30Product
43598-314-60Product
43598-314-90Product
43598-314-05Product
43598-321-30Product
43598-321-60Product
43598-321-90Product
43598-321-05Product
43598-318-30Product
43598-318-60Product
43598-318-90Product
43598-318-05Product
43598-315-30Product
43598-315-60Product
43598-315-90Product
43598-315-05Product
43598-313-30Product
43598-313-60Product
43598-313-90Product
43598-313-05Product

August 2015 Class III Recall: Subpotent Drug

Recall Number
D-1378-2015
Class III Terminated
Reason for Recall
Subpotent Drug: Subpotent atorvastatin.
Initiated
Aug 13, 2015
Reported
Sep 02, 2015
Quantity
a) 16,848 and b) 216 Bottles

Recall Profile & Regulatory Data

Event ID
71984
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Dr. Reddy's Laboratories, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
U.S. Nationwide
Termination Date
Dec 15, 2016
Product Description
Amlodipine besylate and Atorvastatin calcium Tablets,10 mg/40 mg, Packaged in a) 30 Count Bottles (NDC: 43598-315-30) and b) 90 Count Bottles (NDC: 43598-315-90), Rx Only. Manufactured by Dr. Reddy's Laboratories Limited, Bachupally - 500 090 India.
Batch or Lot Expiration Information
Lot# a)
Lot# : C409650, Expiry: 05/2016
Lot# : C409652,Expiry: 05/2016. b)
Lot# : C409652, Expiry: 05/2016
Affected Packages Involved in this Recall
43598-323-30Product
43598-323-60Product
43598-323-90Product
43598-323-05Product
43598-320-30Product
43598-320-60Product
43598-320-90Product
43598-320-05Product
43598-317-30Product
43598-317-60Product
43598-317-90Product
43598-317-05Product
43598-322-30Product
43598-322-60Product
43598-322-90Product
43598-322-05Product
43598-319-30Product
43598-319-60Product
43598-319-90Product
43598-319-05Product
43598-316-30Product
43598-316-60Product
43598-316-90Product
43598-316-05Product
43598-314-30Product
43598-314-60Product
43598-314-90Product
43598-314-05Product
43598-321-30Product
43598-321-60Product
43598-321-90Product
43598-321-05Product
43598-318-30Product
43598-318-60Product
43598-318-90Product
43598-318-05Product
43598-315-30Product
43598-315-60Product
43598-315-90Product
43598-315-05Product
43598-313-30Product
43598-313-60Product
43598-313-90Product
43598-313-05Product

August 2015 Class III Recall: Subpotent Drug

Recall Number
D-1373-2015
Class III Terminated
Reason for Recall
Subpotent Drug: Subpotent atorvastatin.
Initiated
Aug 13, 2015
Reported
Sep 02, 2015
Quantity
1,056 Bottles

Recall Profile & Regulatory Data

Event ID
71984
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Dr. Reddy's Laboratories, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
U.S. Nationwide
Termination Date
Dec 15, 2016
Product Description
Amlodipine besylate and Atorvastatin calcium Tablets, 2.5 mg/10 mg, 30 Count Bottles, Rx Only. Manufactured by Dr. Reddy's Laboratories Limited, Bachupally - 500 090 India. NDC: 43598-323-30.
Batch or Lot Expiration Information
Lot# : C403575, Expiry: 10/2015
Affected Packages Involved in this Recall
43598-323-30Product
43598-323-60Product
43598-323-90Product
43598-323-05Product
43598-320-30Product
43598-320-60Product
43598-320-90Product
43598-320-05Product
43598-317-30Product
43598-317-60Product
43598-317-90Product
43598-317-05Product
43598-322-30Product
43598-322-60Product
43598-322-90Product
43598-322-05Product
43598-319-30Product
43598-319-60Product
43598-319-90Product
43598-319-05Product
43598-316-30Product
43598-316-60Product
43598-316-90Product
43598-316-05Product
43598-314-30Product
43598-314-60Product
43598-314-90Product
43598-314-05Product
43598-321-30Product
43598-321-60Product
43598-321-90Product
43598-321-05Product
43598-318-30Product
43598-318-60Product
43598-318-90Product
43598-318-05Product
43598-315-30Product
43598-315-60Product
43598-315-90Product
43598-315-05Product
43598-313-30Product
43598-313-60Product
43598-313-90Product
43598-313-05Product

May 2015 Class III Recall: Subpotent drug

Recall Number
D-1143-2015
Class III Terminated
Reason for Recall
Subpotent drug
Initiated
May 06, 2015
Reported
Jun 24, 2015
Quantity
N/A

Recall Profile & Regulatory Data

Event ID
71375
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Dr. Reddy's Laboratories, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Mar 31, 2016
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
Batch or Lot Expiration Information
Lot# : a) C401536, Exp 07/2015; b) C401538, Exp 07/2015
Affected Packages Involved in this Recall
43598-323-30Product
43598-323-60Product
43598-323-90Product
43598-323-05Product
43598-320-30Product
43598-320-60Product
43598-320-90Product
43598-320-05Product
43598-317-30Product
43598-317-60Product
43598-317-90Product
43598-317-05Product
43598-322-30Product
43598-322-60Product
43598-322-90Product
43598-322-05Product
43598-319-30Product
43598-319-60Product
43598-319-90Product
43598-319-05Product
43598-316-30Product
43598-316-60Product
43598-316-90Product
43598-316-05Product
43598-314-30Product
43598-314-60Product
43598-314-90Product
43598-314-05Product
43598-321-30Product
43598-321-60Product
43598-321-90Product
43598-321-05Product
43598-318-30Product
43598-318-60Product
43598-318-90Product
43598-318-05Product
43598-315-30Product
43598-315-60Product
43598-315-90Product
43598-315-05Product
43598-313-30Product
43598-313-60Product
43598-313-90Product
43598-313-05Product

May 2015 Class III Recall: Subpotent drug

Recall Number
D-1145-2015
Class III Terminated
Reason for Recall
Subpotent drug
Initiated
May 06, 2015
Reported
Jun 24, 2015
Quantity
N/A

Recall Profile & Regulatory Data

Event ID
71375
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Dr. Reddy's Laboratories, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Mar 31, 2016
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
Batch or Lot Expiration Information
Lot# C309280
Affected Packages Involved in this Recall
43598-323-30Product
43598-323-60Product
43598-323-90Product
43598-323-05Product
43598-320-30Product
43598-320-60Product
43598-320-90Product
43598-320-05Product
43598-317-30Product
43598-317-60Product
43598-317-90Product
43598-317-05Product
43598-322-30Product
43598-322-60Product
43598-322-90Product
43598-322-05Product
43598-319-30Product
43598-319-60Product
43598-319-90Product
43598-319-05Product
43598-316-30Product
43598-316-60Product
43598-316-90Product
43598-316-05Product
43598-314-30Product
43598-314-60Product
43598-314-90Product
43598-314-05Product
43598-321-30Product
43598-321-60Product
43598-321-90Product
43598-321-05Product
43598-318-30Product
43598-318-60Product
43598-318-90Product
43598-318-05Product
43598-315-30Product
43598-315-60Product
43598-315-90Product
43598-315-05Product
43598-313-30Product
43598-313-60Product
43598-313-90Product
43598-313-05Product

May 2015 Class III Recall: Subpotent drug

Recall Number
D-1144-2015
Class III Terminated
Reason for Recall
Subpotent drug
Initiated
May 06, 2015
Reported
Jun 24, 2015
Quantity
N/A

Recall Profile & Regulatory Data

Event ID
71375
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Dr. Reddy's Laboratories, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Mar 31, 2016
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
Batch or Lot Expiration Information
Lot# : a) C401537, Exp 07/2015; b) C401539, Exp 07/2015
Affected Packages Involved in this Recall
43598-323-30Product
43598-323-60Product
43598-323-90Product
43598-323-05Product
43598-320-30Product
43598-320-60Product
43598-320-90Product
43598-320-05Product
43598-317-30Product
43598-317-60Product
43598-317-90Product
43598-317-05Product
43598-322-30Product
43598-322-60Product
43598-322-90Product
43598-322-05Product
43598-319-30Product
43598-319-60Product
43598-319-90Product
43598-319-05Product
43598-316-30Product
43598-316-60Product
43598-316-90Product
43598-316-05Product
43598-314-30Product
43598-314-60Product
43598-314-90Product
43598-314-05Product
43598-321-30Product
43598-321-60Product
43598-321-90Product
43598-321-05Product
43598-318-30Product
43598-318-60Product
43598-318-90Product
43598-318-05Product
43598-315-30Product
43598-315-60Product
43598-315-90Product
43598-315-05Product
43598-313-30Product
43598-313-60Product
43598-313-90Product
43598-313-05Product

May 2015 Class III Recall: Subpotent drug

Recall Number
D-1146-2015
Class III Terminated
Reason for Recall
Subpotent drug
Initiated
May 06, 2015
Reported
Jun 24, 2015
Quantity
N/A

Recall Profile & Regulatory Data

Event ID
71375
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Dr. Reddy's Laboratories, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Mar 31, 2016
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
Batch or Lot Expiration Information
Lot# C402439
Affected Packages Involved in this Recall
43598-323-30Product
43598-323-60Product
43598-323-90Product
43598-323-05Product
43598-320-30Product
43598-320-60Product
43598-320-90Product
43598-320-05Product
43598-317-30Product
43598-317-60Product
43598-317-90Product
43598-317-05Product
43598-322-30Product
43598-322-60Product
43598-322-90Product
43598-322-05Product
43598-319-30Product
43598-319-60Product
43598-319-90Product
43598-319-05Product
43598-316-30Product
43598-316-60Product
43598-316-90Product
43598-316-05Product
43598-314-30Product
43598-314-60Product
43598-314-90Product
43598-314-05Product
43598-321-30Product
43598-321-60Product
43598-321-90Product
43598-321-05Product
43598-318-30Product
43598-318-60Product
43598-318-90Product
43598-318-05Product
43598-315-30Product
43598-315-60Product
43598-315-90Product
43598-315-05Product
43598-313-30Product
43598-313-60Product
43598-313-90Product
43598-313-05Product

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.