December 11, 2019DrugsFDA
QuVa Pharma, Inc. recalls fentaNYL 1000 mcg/20 mL (50 mcg/mL) 20 mL in 20 mL Syringe Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive,
Hazard: Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
December 11, 2019DrugsFDA
QuVa Pharma, Inc. recalls fentaNYL 200 mcg/100 mL (2 mcg/mL) BUPivacaine HCl 0.1% 100 mg/100 mL (1 mg/mL) in 0.9% Sodium Chloride Preservative Fre
Hazard: Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
December 11, 2019DrugsFDA
QuVa Pharma, Inc. recalls fentaNYL 400 mcg/200 mL (2 mcg/mL) ROPivacaine HCl 0.1% 200 mg/200 mL (1 mg/mL) in 0.9% Sodium Chloride 200 mL CADD, Pre
Hazard: Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
December 11, 2019DrugsFDA
QuVa Pharma, Inc. recalls fentaNYL 2000 mcg/100 mL (20 mcg/mL) in 0.9% Sodium Chloride, 100 mL Bag, Preservative Free, Rx, QuVA Pharma 1075 West P
Hazard: Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
December 11, 2019DrugsFDA
QuVa Pharma, Inc. recalls fentaNYL 400 mcg/200 mL (2 mcg/mL) 0.1% ROPivacaine HCl 200 mg/200 mL (1 mg/mL) in 0.9% Sodium Chloride , 200 mL bag, Pr
Hazard: Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
December 11, 2019DrugsFDA
QuVa Pharma, Inc. recalls fentaNYL 200 mcg/100 mL (2 mcg/mL) ROPivacaine HCl 0.2% 200 mg/100 mL (2 mg/mL) in 0.9% Sodium Chloride , 100 mL bag, Pr
Hazard: Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
December 11, 2019DrugsFDA
QuVa Pharma, Inc. recalls fentaNYL 250 mcg/5 mL (50 mcg/mL), 5 mL Syringe, Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100
Hazard: Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
December 11, 2019DrugsFDA
QuVa Pharma, Inc. recalls fentaNYL 200 mcg/100 mL (2 mcg/mL) BUPivacaine HCl 0.1% 100 mg/100 mL (1 mg/mL) in 0.9% Sodium Chloride 100 mL CADD Pres
Hazard: Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
December 11, 2019DrugsFDA
QuVa Pharma, Inc. recalls fentaNYL 2750 mcg/55 mL (50 mcg/mL) 55 mL Syringe, Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 10
Hazard: Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
December 11, 2019DrugsFDA
QuVa Pharma, Inc. recalls fentaNYL 200 mcg/100 mL (2 mcg/mL) 0.125% Bupivacaine HCl 125 mg/100 mL (1.25 mg/mL) in 0.9% Sodium Chloride, 100 mL CAD
Hazard: Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
December 11, 2019DrugsFDA
QuVa Pharma, Inc. recalls fentaNYL 100 mcg/2 mL (50 mcg/mL) Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, T
Hazard: Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
December 11, 2019DrugsFDA
QuVa Pharma, Inc. recalls fentaNYL 1000 mcg/100 mL (10 mcg/mL) in 0.9% Sodium Chloride Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive
Hazard: Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
December 11, 2019DrugsFDA
QuVa Pharma, Inc. recalls fentaNYL 400 mcg/200 mL (2 mcg/mL) ROPivacaine HCl 0.2% 400 mg/200 mL (2 mg/mL) in 0.9% Sodium Chloride 200 mL CADD Pres
Hazard: Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
December 11, 2019DrugsFDA
QuVa Pharma, Inc. recalls fentaNYL 2500 mcg/250 mL (10 mcg/mL) in 0.9% Sodium Chloride 250 mL Bag Preservative Free, Rx, QuVA Pharma 1075 West Par
Hazard: Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
December 11, 2019DrugsFDA
QuVa Pharma, Inc. recalls fentaNYL 500 mcg/250 mL (2 mcg/mL) ROPivacaine HCl 0.2% 500 mg/250 mL (2 mg/mL) in 0.9% Sodium Chloride 250 mL Bag Rx, P
Hazard: Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
December 11, 2019DrugsFDA
QuVa Pharma, Inc. recalls fentaNYL 1500 mcg/30 mL (50 mcg/mL) 30 mL in 35 mL Syringe Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive,
Hazard: Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
December 11, 2019DrugsFDA
QuVa Pharma, Inc. recalls fentaNYL 200 mcg/100 mL (2 mcg/mL) BUPivacaine HCl 0.125% 125 mg/100 mL (1.25 mg/mL) in 0.9% Sodium Chloride Preservativ
Hazard: Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
December 11, 2019DrugsFDA
QuVa Pharma, Inc. recalls fentaNYL 500 mcg/250 mL (2 mcg/mL) BUPivacaine HCl 0.0625% 156.25 mg/250 mL (0.625 mg/mL) in 0.9% Sodium Chloride in 250
Hazard: Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
December 11, 2019DrugsFDA
QuVa Pharma, Inc. recalls fentaNYL 200 mcg/100 mL (2 mcg/mL) ROPivacaine HCl 0.2% 200 mg/100 mL (2 mg/mL) in 0.9% Sodium Chloride 100 mL CADD, Rx,
Hazard: Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
December 11, 2019DrugsFDA
QuVa Pharma, Inc. recalls fentaNYL 500 mcg/250 mL (2 mcg/mL) 0.125% BUPivacaine HCl 312.5 mg/250 mL (1.25 mg/mL) in 0.9% Sodium Chloride 250 mL Ba
Hazard: Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
December 11, 2019DrugsFDA
QuVa Pharma, Inc. recalls fentaNYL 500 mcg/250 mL (2 mcg/mL) Bupivacaine HCl 0.1% 250 mg/250 mL (1 mg/mL) in 0.9% Sodium Chloride 250 mL Bag, Rx o
Hazard: Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
December 11, 2019DrugsFDA
Sanofi-Aventis U.S. LLC recalls Zantac 75 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219. NDC's 0597
Hazard: CGMP Deviations: Presence of NDMA impurity detected in product.
December 11, 2019DrugsFDA
Sanofi-Aventis U.S. LLC recalls Zantac 150 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219. NDC's 667
Hazard: CGMP Deviations: Presence of NDMA impurity detected in product.
December 11, 2019DrugsFDA
Sanofi-Aventis U.S. LLC recalls Regular Strength Zantac 75 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219
Hazard: CGMP Deviations: Presence of NDMA impurity detected in product.
December 11, 2019DrugsFDA
Sanofi-Aventis U.S. LLC recalls Regular Strength Zantac 75 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219
Hazard: CGMP Deviations: Presence of NDMA impurity detected in product.
December 11, 2019DrugsFDA
Sanofi-Aventis U.S. LLC recalls Regular Strength Zantac 150 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-021
Hazard: CGMP Deviations: Presence of NDMA impurity detected in product.
December 11, 2019DrugsFDA
Sanofi-Aventis U.S. LLC recalls Regular Strength Zantac 75 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219
Hazard: CGMP Deviations: Presence of NDMA impurity detected in product.
December 11, 2019DrugsFDA
Sanofi-Aventis U.S. LLC recalls Maximum Strength Zantac 150 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-021
Hazard: CGMP Deviations: Presence of NDMA impurity detected in product.
December 11, 2019DrugsFDA
Sanofi-Aventis U.S. LLC recalls Cool Mint Maximum Strength Zantac 150 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN
Hazard: CGMP Deviations: Presence of NDMA impurity detected in product.
December 11, 2019DrugsFDA
Sanofi-Aventis U.S. LLC recalls Regular Strength Zantac 150 mg Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219
Hazard: CGMP Deviations: Presence of NDMA impurity detected in product.