Drug Recall Enforcement Reports

  • 0 ::
      • Classification : Class II
        • Center_classification_date : 20120731
          • Report_date : 20120808
            • Postal_code : 08807-2862
              • Termination_date : 20130124
                • Recall_initiation_date : 20120409
                  • Recall_number : D-1434-2012
                    • City : Bridgewater
                      • Event_id : 62591
                        • Distribution_pattern : Nationwide and Puerto Rico
                          • Openfda ::
                              • Manufacturer_name ::
                                  • 0 : Dr.Reddy's Laboratories Limited
                                • Unii ::
                                    • 0 : 1J444QC288
                                  • Product_type ::
                                      • 0 : HUMAN PRESCRIPTION DRUG
                                    • Rxcui ::
                                        • 0 : 898356
                                          • 1 : 898342
                                            • 2 : 898353
                                              • 3 : 898350
                                            • Spl_set_id ::
                                                • 0 : ca014f06-982c-6fe1-9948-a3701dd35d34
                                              • Route ::
                                                  • 0 : ORAL
                                                • Generic_name ::
                                                    • 0 : AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE
                                                  • Brand_name ::
                                                      • 0 : AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE
                                                    • Pharm_class_cs ::
                                                        • 0 : Dihydropyridines [Chemical/Ingredient]
                                                      • Product_ndc ::
                                                          • 0 : 55111-340
                                                            • 1 : 55111-341
                                                              • 2 : 55111-339
                                                                • 3 : 55111-338
                                                              • Pharm_class_epc ::
                                                                  • 0 : Dihydropyridine Calcium Channel Blocker [EPC]
                                                                • Substance_name ::
                                                                    • 0 : AMLODIPINE BESYLATE
                                                                      • 1 : BENAZEPRIL HYDROCHLORIDE
                                                                    • Spl_id ::
                                                                        • 0 : 05c1b528-8067-4327-9f50-67d1a73ceb01
                                                                      • Pharm_class_moa ::
                                                                          • 0 : Calcium Channel Antagonists [MoA]
                                                                        • Application_number ::
                                                                            • 0 : ANDA077183
                                                                          • Is_original_packager ::
                                                                              • 0 : 1
                                                                            • Nui ::
                                                                                • 0 : N0000175421
                                                                                  • 1 : N0000007556
                                                                                    • 2 : N0000000069
                                                                                  • Package_ndc ::
                                                                                      • 0 : 55111-339-05
                                                                                        • 1 : 55111-340-30
                                                                                          • 2 : 55111-339-01
                                                                                            • 3 : 55111-338-05
                                                                                              • 4 : 55111-341-05
                                                                                                • 5 : 55111-339-30
                                                                                                  • 6 : 55111-338-01
                                                                                                    • 7 : 55111-341-30
                                                                                                      • 8 : 55111-341-01
                                                                                                        • 9 : 55111-340-01
                                                                                                          • 10 : 55111-338-30
                                                                                                            • 11 : 55111-340-05
                                                                                                      • Recalling_firm : Dr. Reddy's Laboratories, Inc.
                                                                                                        • Voluntary_mandated : Voluntary: Firm Initiated
                                                                                                          • State : NJ
                                                                                                            • Reason_for_recall : Adulterated Presence of Foreign Tablets: Dr. Reddy's Laboratories has received complaints of mislabeled bottles of Amlodipine Besylate and Benazepril Hydrochloride Capsules and Ciprofloxacin Tablets.
                                                                                                              • Initial_firm_notification : Letter
                                                                                                                • Status : Terminated
                                                                                                                  • Product_type : Drugs
                                                                                                                    • Country : United States
                                                                                                                      • Product_description : Dr. Reddy's Amlodipine Besylate and Benazepril Hydrochloride 5 mg*/20 mg, 500 Capsules, Rx only, Mfd. By: Dr. Reddy's Laboratories Limited, Bachepalli - 502 325 INDIA, NDC 55111-340-05
                                                                                                                        • Code_info : C201293 Exp Date 08/2013
                                                                                                                          • Address_1 : 200 Somerset Corporate Blvd Fl 7th
                                                                                                                            • Address_2 :
                                                                                                                              • Product_quantity : 1656 bottles

Drug Recall Enforcement Reports

  • 1 ::
      • Classification : Class II
        • Center_classification_date : 20120731
          • Report_date : 20120808
            • Postal_code : 13788-0416
              • Termination_date : 20150417
                • Recall_initiation_date : 20120525
                  • Recall_number : D-1431-2012
                    • City : Hobart
                      • Event_id : 61967
                        • Distribution_pattern : Nationwide
                          • Openfda ::
                            • Recalling_firm : Mallinckrodt Inc.
                              • Voluntary_mandated : Voluntary: Firm Initiated
                                • State : NY
                                  • Reason_for_recall : CGMP Deviations: This product is being recalled because expired flavoring was used in the manufacturing of these lots.
                                    • Initial_firm_notification : Letter
                                      • Status : Terminated
                                        • Product_type : Drugs
                                          • Country : United States
                                            • Product_description : Hydrocodone Bitartrate and Acetaminophen Oral Solution, 7.5 mg/500 mg per 15 mL, 16 fl oz (473 mL) bottle, Rx only, Mallinckrodt Inc., Hazelwood, MO 63042 USA, NDC 0406-0375-16, UPC 3 0406-0375-16 1.
                                              • Code_info : Lot #: 0375P76192, Exp 07/12; 0375T80512, Exp 08/13; 0375T81209, Exp 09/13
                                                • Address_1 : 172 Railroad Avenue
                                                  • Address_2 :
                                                    • Product_quantity : 44,330 bottles

    Drug Recall Enforcement Reports

    • 2 ::
        • Classification : Class II
          • Center_classification_date : 20120810
            • Report_date : 20120822
              • Postal_code : 34474-5138
                • Termination_date : 20140813
                  • Recall_initiation_date : 20120525
                    • Recall_number : D-1498-2012
                      • City : Ocala
                        • More_code_info :
                          • Event_id : 62416
                            • Distribution_pattern : Nationwide, Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, and West Indies
                              • Openfda ::
                                • Recalling_firm : Franck's Lab Inc., d.b.a. Franck's Compounding Lab
                                  • Voluntary_mandated : Voluntary: Firm Initiated
                                    • State : FL
                                      • Reason_for_recall : Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.
                                        • Initial_firm_notification : Letter
                                          • Status : Terminated
                                            • Product_type : Drugs
                                              • Country : United States
                                                • Product_description : DEXAMETHASONE/BACTERIOSTATIC WATER IONTOPHORESIS 0.5MG/5ML(0.1MG/ML) INJECTABL 30 ML (1 PRODUCT) 40 ML DEXAMETHASONE SDPF (0.1ML SYRINGE, 31G, 5/16" ) 0.4MG/ML INJECTABLE 0.3 ML 0.5 ML DEXAMETHASONE SODIUM PHOSPHATE (P.F.) 10MG/ML (1%) INJECTABLE 0.05 ML 1 ML 16 ML 2 ML 24 ML 3 ML 32 ML 8 ML DEXAMETHASONE SODIUM PHOSPHATE (P.F.) 4MG/ML (0.4%) INJECTABLE 0.4 ML 2 ML 3 ML 5 ML 6 ML DEXAMETHASONE SODIUM PHOSPHATE (P.F.) 80MG/ML (8%) INJECTABLE 100 ML 40 ML DEXAMETHASONE SODIUM PHOSPHATE (P.F.) 8MG/ML (800MCG/0.1ML) INJECTABLE 0.1 ML DEXAMETHASONE SODIUM PHOSPHATE 40MG/ML INJECTABLE 50 ML DEXAMETHASONE SODIUM PHOSPHATE 4MG/ML INJECTABLE 100 ML 180 MLS 240 MLS 30 ML 60 ML DEXAMETHASONE SODIUM PHOSPHATE IN BSS (P.F.) 10MG/ML (1%) INJECTABLE 1 ML DEXAMETHASONE SODIUM PHOSPHATE, 30ML VIAL** 4MG/ML INJECTABLE 30 ML DEXAMETHASONE SOLUTION - NACL, P.F. 0.1% OPHTHALMIC 15 ML DEXAMETHASONE, SDPF - (0.07ML SYRINGE, 30G, 1/2") 80MG/ML INJECTABLE 0.35 ML 0.7 ML
                                                  • Code_info : Rx #: 0400257
                                                    • Address_1 : 1210 SW 33rd Avenue
                                                      • Address_2 :
                                                        • Product_quantity : 1 unit

      Drug Recall Enforcement Reports

      • 3 ::
          • Classification : Class II
            • Center_classification_date : 20120810
              • Report_date : 20120822
                • Postal_code : 34474-5138
                  • Termination_date : 20140813
                    • Recall_initiation_date : 20120525
                      • Recall_number : D-1465-2012
                        • City : Ocala
                          • More_code_info :
                            • Event_id : 62416
                              • Distribution_pattern : Nationwide, Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, and West Indies
                                • Openfda ::
                                  • Recalling_firm : Franck's Lab Inc., d.b.a. Franck's Compounding Lab
                                    • Voluntary_mandated : Voluntary: Firm Initiated
                                      • State : FL
                                        • Reason_for_recall : Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.
                                          • Initial_firm_notification : Letter
                                            • Status : Terminated
                                              • Product_type : Drugs
                                                • Country : United States
                                                  • Product_description : BIEST(80/20) 6.25MG/GM (1.25MG/0.2ML) I-CREAM 6 ML (5 DIFFERENT PRODUCTS)
                                                    • Code_info : Rx #: 0392274
                                                      • Address_1 : 1210 SW 33rd Avenue
                                                        • Address_2 :
                                                          • Product_quantity : 7 units

        Drug Recall Enforcement Reports

        • 4 ::
            • Classification : Class II
              • Center_classification_date : 20120810
                • Report_date : 20120822
                  • Postal_code : 34474-5138
                    • Termination_date : 20140815
                      • Recall_initiation_date : 20120521
                        • Recall_number : D-1633-2012
                          • City : Ocala
                            • More_code_info :
                              • Event_id : 62443
                                • Distribution_pattern : Nationwide, Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, West Indies
                                  • Openfda ::
                                    • Recalling_firm : Franck's Lab Inc., d.b.a. Franck's Compounding Lab
                                      • Voluntary_mandated : Voluntary: Firm Initiated
                                        • State : FL
                                          • Reason_for_recall : Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.
                                            • Initial_firm_notification : Letter
                                              • Status : Terminated
                                                • Product_type : Drugs
                                                  • Country : United States
                                                    • Product_description : TROPICAMIDE/PHENYLEPHRINE OPHTHALMIC 15:1 SOLUTION 128 ML 480 ML 496 ML 576 ML 90 ML (5 DIFFERENT PRODUCTS)
                                                      • Code_info : Rx #'s: 0394909 0394909 0394909 0394909 0394909
                                                        • Address_1 : 1210 SW 33rd Avenue
                                                          • Address_2 :
                                                            • Product_quantity : 6 units