Drug Recall Enforcement Reports

  • 0 ::
      • Classification : Class III
        • Center_classification_date : 20120702
          • Report_date : 20120711
            • Postal_code : 19034-2210
              • Termination_date : 20130411
                • Recall_initiation_date : 20120517
                  • Recall_number : D-1404-2012
                    • City : Fort Washington
                      • Event_id : 61872
                        • Distribution_pattern : Nationwide
                          • Openfda ::
                            • Recalling_firm : Mcneil Consumer Healthcare, Div Of Mcneil-ppc, Inc.
                              • Voluntary_mandated : Voluntary: Firm Initiated
                                • State : PA
                                  • Reason_for_recall : Defective Container; damaged blister units
                                    • Initial_firm_notification : Letter
                                      • Status : Terminated
                                        • Product_type : Drugs
                                          • Country : United States
                                            • Product_description : Imodium Multi-Symptom Relief Caplets, Loperamide HCl 2 mg/Simethicone 125 mg, 18 count blister pack cartons, McNeil Consumer Healthcare, Div of McNeil-PPC Inc., Fort Washington, PA
                                              • Code_info : Lot #CMF023, Expiration 07/13.
                                                • Address_1 : 7050 Camp Hill Rd
                                                  • Address_2 :
                                                    • Product_quantity : 53,892 packages

    Drug Recall Enforcement Reports

    • 1 ::
        • Classification : Class III
          • Center_classification_date : 20120620
            • Report_date : 20120627
              • Postal_code : 60045
                • Termination_date : 20130808
                  • Recall_initiation_date : 20120405
                    • Recall_number : D-1390-2012
                      • City : Lake Forest
                        • Event_id : 62053
                          • Distribution_pattern : Nationwide
                            • Openfda ::
                                • Manufacturer_name ::
                                    • 0 : Hospira, Inc.
                                  • Product_type ::
                                      • 0 : HUMAN PRESCRIPTION DRUG
                                    • Rxcui ::
                                        • 0 : 1658265
                                          • 1 : 1658259
                                            • 2 : 1658264
                                              • 3 : 829734
                                                • 4 : 1658262
                                              • Spl_set_id ::
                                                  • 0 : 22ca78b4-f5a3-4144-cf89-5f633acf1e6d
                                                • Route ::
                                                    • 0 : INTRAVENOUS
                                                  • Generic_name ::
                                                      • 0 : MAGNESIUM SULFATE HEPTAHYDRATE
                                                    • Brand_name ::
                                                        • 0 : MAGNESIUM SULFATE
                                                      • Product_ndc ::
                                                          • 0 : 0409-6730
                                                            • 1 : 0409-6729
                                                          • Substance_name ::
                                                              • 0 : MAGNESIUM SULFATE HEPTAHYDRATE
                                                            • Spl_id ::
                                                                • 0 : e0d6a008-e340-4d8c-8aa0-1202a3577cbc
                                                              • Application_number ::
                                                                  • 0 : NDA020309
                                                                • Is_original_packager ::
                                                                    • 0 : 1
                                                                  • Package_ndc ::
                                                                      • 0 : 0409-6729-09
                                                                        • 1 : 0409-6729-24
                                                                          • 2 : 0409-6729-23
                                                                            • 3 : 0409-6729-03
                                                                              • 4 : 0409-6730-13
                                                                        • Recalling_firm : Hospira, Inc.
                                                                          • Voluntary_mandated : Voluntary: Firm Initiated
                                                                            • State : IL
                                                                              • Reason_for_recall : Superpotent (Single Ingredient) Drug: Above specification assay results for percentage of magnesium sulfate.
                                                                                • Initial_firm_notification : Letter
                                                                                  • Status : Terminated
                                                                                    • Product_type : Drugs
                                                                                      • Country : United States
                                                                                        • Product_description : Magnesium Sulfate in Water for Injection, 40 mg/mL (0.325 mEq Mg++/mL), 2 g total, 50 mL Flexible Container, Rx only, Hospira, Inc., Lake Forest, IL 60045; NDC 0409-6729-24.
                                                                                          • Code_info : Lot #: 04510KL*, Exp 01OCT2012; *lot number may have 01 or 02 following it
                                                                                            • Address_1 : 600 N Field Dr Bldg J45
                                                                                              • Address_2 :
                                                                                                • Product_quantity : 164,568 containers

    Drug Recall Enforcement Reports

    • 2 ::
        • Classification : Class I
          • Center_classification_date : 20120618
            • Report_date : 20120627
              • Postal_code : 74146-6234
                • Termination_date : 20120724
                  • Recall_initiation_date : 20101110
                    • Recall_number : D-1385-2012
                      • City : Tulsa
                        • Event_id : 61233
                          • Distribution_pattern : FL
                            • Openfda ::
                              • Recalling_firm : Physicians Total Care, Inc
                                • Voluntary_mandated : Voluntary: Firm Initiated
                                  • State : OK
                                    • Reason_for_recall : Labeling: Label mix-up; Bottles labeled to contain Morphine Sulfate IR may contain Morphine Sulfate ER and vice-versa.
                                      • Initial_firm_notification : FAX
                                        • Status : Terminated
                                          • Product_type : Drugs
                                            • Country : United States
                                              • Product_description : Morphine Sulfate Extended Release tablet, 30 mg, 60 tablet bottles, Rx only, Physician Total Care, Inc, Tulsa, Ok 74146-6234, NDC 54868-4033-00
                                                • Code_info : PTC Drug Number: 4033. PTC Batch Number: 65IT. Batch Date: 10/13/2010. Expiration Date: 11/30/2011. NDC: 54868-4033-00
                                                  • Address_1 : 12515 E 55th St Ste 100
                                                    • Address_2 :
                                                      • Product_quantity : 540 tablets (9 containers of 60 tablets each)

      Drug Recall Enforcement Reports

      • 3 ::
          • Classification : Class II
            • Center_classification_date : 20120802
              • Report_date : 20120808
                • Postal_code :
                  • Termination_date : 20130919
                    • Recall_initiation_date : 20120430
                      • Recall_number : D-1439-2012
                        • City : Toronto
                          • Event_id : 62574
                            • Distribution_pattern : Nationwide and Puerto Rico
                              • Openfda ::
                                • Recalling_firm : Apotex Inc.
                                  • Voluntary_mandated : Voluntary: Firm Initiated
                                    • State :
                                      • Reason_for_recall : Presence of Particulate Matter: Lots identified in this recall notification may contain small particulates.
                                        • Initial_firm_notification : Letter
                                          • Status : Terminated
                                            • Product_type : Drugs
                                              • Country : Canada
                                                • Product_description : Dorzolamide HCI/Timolol Maleate Ophthalmic Solution 22.3mg/6.8mg per mL, 10mL bottle, For Topical Application in the Eye, Sterile Ophthalmic Solution, Rx Only, Mfg by: Apotex Inc., Toronto, Ontario, Canada M9L 1T9
                                                  • Code_info : Lot #s: JN1060, JN1061, JN1062, Exp 06/12
                                                    • Address_1 : 150 Signet Drive
                                                      • Address_2 :
                                                        • Product_quantity : 119,794 Bottles

        Drug Recall Enforcement Reports

        • 4 ::
            • 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