Recall Enforment Report D-1379-2015
Recall Details
Multi event Drug Recall Enforcement Report Class III voluntary initiated by Dr. Reddy's Laboratories, Inc., originally initiated on 08-13-2015 for the product 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. The product was recalled due to subpotent drug: subpotent atorvastatin.. 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-1379-2015 | 08-13-2015 | 09-02-2015 | Class III | 3840 Bottles | 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. | Subpotent Drug: Subpotent atorvastatin. | Terminated |
D-1376-2015 | 08-13-2015 | 09-02-2015 | Class III | a) 14,640 and b) 624 Bottles | 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. | Subpotent Drug: Subpotent atorvastatin. | Terminated |
D-1374-2015 | 08-13-2015 | 09-02-2015 | Class III | 576 Bottles | 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. | Subpotent Drug: Subpotent atorvastatin. | Terminated |
D-1375-2015 | 08-13-2015 | 09-02-2015 | Class III | 984 Bottles | 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. | Subpotent Drug: Subpotent atorvastatin. | Terminated |
D-1378-2015 | 08-13-2015 | 09-02-2015 | Class III | a) 16,848 and b) 216 Bottles | 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. | Subpotent Drug: Subpotent atorvastatin. | Terminated |
D-1373-2015 | 08-13-2015 | 09-02-2015 | Class III | 1,056 Bottles | 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. | Subpotent Drug: Subpotent atorvastatin. | Terminated |
D-1377-2015 | 08-13-2015 | 09-02-2015 | Class III | a) 16,080 and b) 480 Bottles | 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 | Subpotent Drug: Subpotent atorvastatin. | 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 |