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Recall Enforment Report D-1145-2015

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/40mg, 90-count bottle, Rx Only Manufactured by Dr. Reddy's Laboratories Limited Bachupally, 500 090 India, NDC 43598-315-90 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 Quantity Product Description Recall Reason Status
D-1145-201505-06-201506-24-2015Class IIIAmlodipine besylate and Atorvastatin calcium tablets, 10mg/40mg, 90-count bottle, Rx Only Manufactured by Dr. Reddy's Laboratories Limited Bachupally, 500 090 India, NDC 43598-315-90Subpotent drugTerminated
D-1144-201505-06-201506-24-2015Class IIIAmlodipine 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 IndiaSubpotent drugTerminated
D-1146-201505-06-201506-24-2015Class IIIAmlodipine 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 IndiaSubpotent drugTerminated
D-1143-201505-06-201506-24-2015Class IIIAmlodipine 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 IndiaSubpotent drugTerminated

Recalled Products

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