Drug and pharmaceutical recalls

17624 federal recalls on file. Federal recalls for prescription drugs, OTC medications, supplements, and pharmaceuticals. Sourced from the FDA and translated into plain English.

2019-12-11FDA-DrugQuVa Pharma, Inc.Class II
fentaNYL 2000 mcg/100 mL (20 mcg/mL) in 0.9% Sodium Chloride, 100 mL Bag, Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1094-36
Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
2019-12-11FDA-DrugQuVa Pharma, Inc.Class II
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, Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1207-37
Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
2019-12-11FDA-DrugQuVa Pharma, Inc.Class II
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, Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1108-36
Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
2019-12-11FDA-DrugQuVa Pharma, Inc.Class II
fentaNYL 250 mcg/5 mL (50 mcg/mL), 5 mL Syringe, Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1098-44
Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
2019-12-11FDA-DrugQuVa Pharma, Inc.Class II
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 Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1255-75
Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
2019-12-11FDA-DrugQuVa Pharma, Inc.Class II
fentaNYL 2750 mcg/55 mL (50 mcg/mL) 55 mL Syringe, Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1100-50
Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
2019-12-11FDA-DrugQuVa Pharma, Inc.Class II
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 CADD Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1202-75
Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
2019-12-11FDA-DrugQuVa Pharma, Inc.Class II
fentaNYL 100 mcg/2 mL (50 mcg/mL) Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1097-43
Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
2019-12-11FDA-DrugQuVa Pharma, Inc.Class II
fentaNYL 1000 mcg/100 mL (10 mcg/mL) in 0.9% Sodium Chloride Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1092-36
Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
2019-12-11FDA-DrugQuVa Pharma, Inc.Class II
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 Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1440-76
Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
2019-12-11FDA-DrugQuVa Pharma, Inc.Class II
fentaNYL 2500 mcg/250 mL (10 mcg/mL) in 0.9% Sodium Chloride 250 mL Bag Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1093-37
Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
2019-12-11FDA-DrugQuVa Pharma, Inc.Class II
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, Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1225-37
Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
2019-12-11FDA-DrugQuVa Pharma, Inc.Class II
fentaNYL 1500 mcg/30 mL (50 mcg/mL) 30 mL in 35 mL Syringe Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1099-49
Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
2019-12-11FDA-DrugQuVa Pharma, Inc.Class II
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 Preservative Free, 100 mL in 150 Bag, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1104-36
Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
2019-12-11FDA-DrugQuVa Pharma, Inc.Class II
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 mL Bag, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1269-37
Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
2019-12-11FDA-DrugQuVa Pharma, Inc.Class II
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, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478NDC 70092-1259-75
Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
2019-12-11FDA-DrugQuVa Pharma, Inc.Class II
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 Bag, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1105-37
Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
2019-12-11FDA-DrugQuVa Pharma, Inc.Class II
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 only, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1160-37
Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
2019-12-11FDA-DrugSanofi-Aventis U.S. LLCClass II
Zantac 75 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219. NDC's 0597-0122-01 0597-0122-08 0597-0122-13 0597-0122-37 0597-0122-40 0597-0122-54 0597-0122-61 0597-0122-81 0597-0122-96
CGMP Deviations: Presence of NDMA impurity detected in product.
2019-12-11FDA-DrugSanofi-Aventis U.S. LLCClass II
Zantac 150 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219. NDC's 66715-9736-2 66715-9736-3 66715-9736-8
CGMP Deviations: Presence of NDMA impurity detected in product.
2019-12-11FDA-DrugSanofi-Aventis U.S. LLCClass II
Regular Strength Zantac 75 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219. NDC 68151-2584-0.
CGMP Deviations: Presence of NDMA impurity detected in product.
2019-12-11FDA-DrugSanofi-Aventis U.S. LLCClass II
Regular Strength Zantac 75 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219. NDC's 67751-152-01 67751-152-02
CGMP Deviations: Presence of NDMA impurity detected in product.
2019-12-11FDA-DrugSanofi-Aventis U.S. LLCClass II
Regular Strength Zantac 150 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219. NDC 67751-151-01.
CGMP Deviations: Presence of NDMA impurity detected in product.
2019-12-11FDA-DrugSanofi-Aventis U.S. LLCClass II
Regular Strength Zantac 75 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219. NDC 50269-222-25.
CGMP Deviations: Presence of NDMA impurity detected in product.
2019-12-11FDA-DrugSanofi-Aventis U.S. LLCClass II
Maximum Strength Zantac 150 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219. NDC's: 0597-0121-01, 0597-0121-06, 0597-0121-08, 0597-0121-09, 0597-0121-11, 0597-0121-24, 0597-0121-38, 0597-0121-50, 0597-0121-64, 0597-0121-66, 0597-0121-68, 0597-0121-78, 0597-0121-80, 0597-0121-82, 0597-0121-85, 0597-0121-90, 0597-0121-94.
CGMP Deviations: Presence of NDMA impurity detected in product.
2019-12-11FDA-DrugSanofi-Aventis U.S. LLCClass II
Cool Mint Maximum Strength Zantac 150 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219 NDC's: 41167-0320-1 41167-0320-2 41167-0320-3 41167-0320-4 41167-0320-5 41167-0320-6 41167-0320-7
CGMP Deviations: Presence of NDMA impurity detected in product.
2019-12-11FDA-DrugSanofi-Aventis U.S. LLCClass II
Regular Strength Zantac 150 mg Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219. NDC 05269-220-25.
CGMP Deviations: Presence of NDMA impurity detected in product.
2019-12-11FDA-DrugSanofi-Aventis U.S. LLCClass II
Maximum Strength Zantac 150 mg Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219. NDC's 41167-0310-1 41167-0310-2 41167-0310-3 41167-0310-4 41167-0310-6 41167-0310-7 41167-0310-8
CGMP Deviations: Presence of NDMA impurity detected in product.
2019-12-11FDA-DrugSanofi-Aventis U.S. LLCClass II
Regular Strength Zantac 75 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219 NDC's 41167-0300-0, 41167-0300-1, 41167-0300-3, 41167-0300-5, 41167-0300-6, 41167-0300-7, 41167-0300-8
CGMP Deviations: Presence of NDMA impurity detected in product.
2019-12-11FDA-DrugSanofi-Aventis U.S. LLCClass II
Cool Mint Tablets Maximum Strength Zantac 150 mg Sanofi Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219. NDC's: 0597-0120-06, 0597-0120-08, 0597-0120-09, 0597-0120-24, 0597-0120-38, 0597-0120-50, 0597-0120-76, 0597-0120-78, 0597-0120-80, 0597-0120-82, 0597-0120-87.
CGMP Deviations: Presence of NDMA impurity detected in product.

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