DrugAug 21, 2019
Tamsulosin Hydrochloride Capsules, USP 0.4 mg recall — FDA D-1844-2019
Failed Dissolution Specifications
Class IIFDA: TerminatedMacleods Pharma Usa Inc.
August 2019 recalls — page 11
These records include useful source details for the selected month.
DrugAug 21, 2019
MAXIMUM STRENGTH HYDROCORTISONE CREAM WITH ALOE Hydrocortisone Cream With Aloe recall — FDA D-1731-2019
CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing process.
Class IIFDA: TerminatedUS Pharmaceuticals Inc.
DrugAug 21, 2019
Infusion Options Cisplatin 40 MG / 500 ml NS IVPB WITH Mannitol 40 G recall — FDA D-1759-2019
Lack of Assurance of Sterility
Class IIFDA: TerminatedInfusion Options, Inc.
DrugAug 21, 2019
US Pharmaceuticals Wonder Freeze Pain Releiving Gel with ILEX, Menthol 5% recall — FDA D-1740-2019
CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing process.
Class IIFDA: TerminatedUS Pharmaceuticals Inc.
DrugAug 21, 2019
Infusion Options DEXAMETHASONE 10 MG / 50 ML NS IVPB recall — FDA D-1767-2019
Lack of Assurance of Sterility
Class IIFDA: TerminatedInfusion Options, Inc.
DrugAug 21, 2019
Infusion Options METHOTREXATE 25 MG / 1 ML IM SYR recall — FDA D-1790-2019
Lack of Assurance of Sterility
Class IIFDA: TerminatedInfusion Options, Inc.
DrugAug 21, 2019
Infusion Options REMICADE 680 MG QS 250 ML 0.9% NACL IVPB recall — FDA D-1808-2019
Lack of Assurance of Sterility
Class IIFDA: TerminatedInfusion Options, Inc.
DrugAug 21, 2019
Infusion Options Etoposide 184 MG / 500 ml NS IVPB recall — FDA D-1776-2019
Lack of Assurance of Sterility
Class IIFDA: TerminatedInfusion Options, Inc.
DrugAug 21, 2019
Infusion Options BEVACIZUMAB 784 MG / 100 ML NS IVPB recall — FDA D-1752-2019
Lack of Assurance of Sterility
Class IIFDA: TerminatedInfusion Options, Inc.
DrugAug 21, 2019
Infusion Options PEMETREXED 910 MG QS 100 ML NS IVPB recall — FDA D-1803-2019
Lack of Assurance of Sterility
Class IIFDA: TerminatedInfusion Options, Inc.
DrugAug 21, 2019
Infusion Options CARFILZOMIB 65 MG IN 50 ML D5W IVPB recall — FDA D-1757-2019
Lack of Assurance of Sterility
Class IIFDA: TerminatedInfusion Options, Inc.
DrugAug 21, 2019
US Pharmaceuticals Kool Comfort Cooling Pain Relief, 5% Menthol recall — FDA D-1739-2019
CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing process.
Class IIFDA: TerminatedUS Pharmaceuticals Inc.
DrugAug 21, 2019
Infusion Options ADO-TRASTUZUMAB 210 MG/250 ml NS recall — FDA D-1747-2019
Lack of Assurance of Sterility
Class IIFDA: TerminatedInfusion Options, Inc.
DrugAug 21, 2019
Infusion Options Cyclophosphamide 840 MG / 250 ML NS IVPB recall — FDA D-1761-2019
Lack of Assurance of Sterility
Class IIFDA: TerminatedInfusion Options, Inc.
DrugAug 21, 2019
Infusion Options Cytarabine 128 MG/250 ML D5W IVPB recall — FDA D-1762-2019
Lack of Assurance of Sterility
Class IIFDA: TerminatedInfusion Options, Inc.
DrugAug 21, 2019
Infusion Options VINCRISTINE 1 MG /50 ML NS IVPB recall — FDA D-1818-2019
Lack of Assurance of Sterility
Class IIFDA: TerminatedInfusion Options, Inc.
DrugAug 21, 2019
US Pharmaceuticals Cool Hot Ice Analgesic Gel, 8 oz (227 g) recall — FDA D-1738-2019
CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing process.
Class IIFDA: TerminatedUS Pharmaceuticals Inc.
DrugAug 21, 2019
Infusion Options IRINOTECAN 250 MG /500 ml D5W IVPB recall — FDA D-1787-2019
Lack of Assurance of Sterility
Class IIFDA: TerminatedInfusion Options, Inc.
DrugAug 21, 2019
Infusion Options AVASTIN 630 MG / 100 ML 0.9% NACL IVPB recall — FDA D-1750-2019
Lack of Assurance of Sterility
Class IIFDA: TerminatedInfusion Options, Inc.
DrugAug 21, 2019
Infusion Options PACLITAXEL 258 MG / 500 ML NS IVPB recall — FDA D-1798-2019
Lack of Assurance of Sterility
Class IIFDA: TerminatedInfusion Options, Inc.
DrugAug 21, 2019
Infusion Options TRASTUZUMAB 427 MG / 250 ml NS IVPB recall — FDA D-1815-2019
Lack of Assurance of Sterility
Class IIFDA: TerminatedInfusion Options, Inc.
DrugAug 21, 2019
US Pharmaceuticals CRYO-273 Cold Pain Relieving Gel Roll-On 3 FL recall — FDA D-1737-2019
CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing process.
Class IIFDA: TerminatedUS Pharmaceuticals Inc.
DrugAug 21, 2019
Infusion Options VELCADE 2.1 mg / 0.84 ml SQ SYRINGE recall — FDA D-1816-2019
Lack of Assurance of Sterility
Class IIFDA: TerminatedInfusion Options, Inc.
DrugAug 21, 2019
Infusion Options HERCEPTIN 400 MG / 250 ML NS IVPB recall — FDA D-1783-2019
Lack of Assurance of Sterility
Class IIFDA: TerminatedInfusion Options, Inc.
How to use this monthly recall archive
Use this page to compare the recalls reported during the month, then open an individual record for the exact reason, classification, company, remedy or distribution information available from the official source. Monthly counts are descriptive, not a safety rating.