Drug Recall Enforcement Reports

  • 0 ::
      • 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

    • 1 ::
        • 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

      • 2 ::
          • 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

      • 3 ::
          • 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

        • 4 ::
            • 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