Drug and pharmaceutical recalls

17728 federal recalls on file. Federal recalls for prescription drugs, OTC medications, supplements, and pharmaceuticals. Sourced from the FDA and translated into plain English.

2018-08-01FDA-DrugMAJOR PHARMACEUTICALSClass II
Unit Dose Valsartan Tablets, USP, 80 mg. Rx only, Distributed by: Major Pharmaceuticals, Livonia, MI 48152, NDC# 0904-6594-61.
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
2018-07-25FDA-DrugAvella of Deer Valley, Inc. Store 38Class II
PHENYLephrine 10 mg (PHENYLephrine HCL (USP) 10mg, 0.9% Sodium Chloride (USP) 250 mL. Volume: 251 mL Single dose bag. For: Redlands Community Hospital Pharmacy. BY: Advanced Pharma, 9265 Kirby Dr., Houston, TX 77054 NDC 15082-856-25
Lack of Assurance of Sterility: Potential leakage of bags.
2018-07-25FDA-DrugAvella of Deer Valley, Inc. Store 38Class II
ePHEDrine Sulfate, USP 50 mg in 0.9% Sodium Chloride, USP QS 10mL. 50 mg/10 mL (5 mg per mL). Volume 10 mL Single dose syringe. Avella of Houston, 9265 Kirby Dr., Houston, TX 77054 NDC 42852-895-61
Lack of Assurance of Sterility: Potential leakage of bags.
2018-07-25FDA-DrugAvella of Deer Valley, Inc. Store 38Class II
ePHEDrine Sulfate, USP 25 mg in 0.9% Sodium Chloride, USP QS 5mL. Volume 5 mL Single dose syringe. Avella of Houston, 9265 Kirby Dr., Houston, TX 77054 NDC 42852-805-67
Lack of Assurance of Sterility: Potential leakage of bags.
2018-07-25FDA-DrugAvella of Deer Valley, Inc. Store 38Class II
PHENYLephrine 20 mg (PHENYLephrine HCL (USP) 20 mg, 5% Dextrose (USP) 250 mL) Volume: 252 mL. Single dose bag. For: Vidant Medical Center, By: Avella of Houston, 9265 Kirby Dr., Houston, TX 77054. NDC 42852-894-25
Lack of Assurance of Sterility: Potential leakage of bags.
2018-07-25FDA-DrugAvella of Deer Valley, Inc. Store 38Class II
NORepiNEPHrine4mg (Norepinephrine Bitartrate (USP) 4 mg added to 0.9% Sodium Chloride (USP) 250 mL Volume: 254 mL Single dose bag. Avella of Houston, 9265 Kirby Dr. Houston, TX 77054. NDC 42852-860-25
Lack of Assurance of Sterility: Potential leakage of bags.
2018-07-25FDA-DrugAvella of Deer Valley, Inc. Store 38Class II
NORepiNEPHrine4mg (Norepinephrine Bitartrate (USP) 4 mg added to 5% Dextrose Inj. (USP) 250 mL (Concentration 16 mcg/mL) Volume: 254 mL Single dose bag. Avella of Houston, 9265 Kirby Dr. Houston, TX 77054. NDC 42852-807-25
Lack of Assurance of Sterility: Potential leakage of bags.
2018-07-25FDA-DrugAvella of Deer Valley, Inc. Store 38Class II
NORepiNEPHrine Bitartrate, USP 160 mcg in 5% Dextrose, USP QS 10mL. Volume 10mL. Single dose syringe. Avella of Houston, 9265 Kirby Dr. Houston, TX 77054. NDC 42852-807-61
Lack of Assurance of Sterility: Potential leakage of bags.
2018-07-25FDA-DrugAvella of Deer Valley, Inc. Store 38Class II
NORepiNEPHrine 16 (NORepiNEPHrine Bitartrate (USP) 16 mg, 5% Dextrose Inj. (USP) 250 mL. Volume: 266 mL. Single dose bag. Avella of Houston, 9265 Kirby Dr. Houston, TX 77054. NDC 42852-834-25
Lack of Assurance of Sterility: Potential leakage of bags.
2018-07-25FDA-DrugAvella of Deer Valley, Inc. Store 38Class II
Midazolam 1 mg/mL (Midazolam HCL (USP) 55 mg, 0.9% Sodium Chloride, (USP) QS 55 mL) Volume: 55mL. Single dose syringe. Advanced Pharma, 9265 Kirby Dr., Houston TX 77054. NDC 15082-401-76
Lack of Assurance of Sterility: Potential leakage of bags.
2018-07-25FDA-DrugAvella of Deer Valley, Inc. Store 38Class II
Midazolam 0.5mg/mL (Midazolam HCL (USP) 50 mg, 0.9% Sodium Chloride, USP QS 100 mL) Volume: 100 mL. Single dose bag. For: Coral Gables Hospital, By: Advanced Pharma, 9265 Kirby Dr., Houston TX 77054. NDC 15082-408-10
Lack of Assurance of Sterility: Potential leakage of bags.
2018-07-25FDA-DrugAvella of Deer Valley, Inc. Store 38Class II
Midazolam 1 mg/mL (Midazolam HCL USP 30 mg, 0.9% Sodium Chloride, USP QS 30 mL) Volume: 30 mL. Single dose syringe. For: Methodist Willowbrook Hospital, By: Advanced Pharma, 9265 Kirby Dr., Houston TX 77054. NDC 15082-401-63
Lack of Assurance of Sterility: Potential leakage of bags.
2018-07-25FDA-DrugAvella of Deer Valley, Inc. Store 38Class II
MORphine 150 mg (Morphine Sulfate, USP 150mg in 0.9% Sodium Chloride, USP QS 30mL). Volume 30 mL. Single dose syringe. Avella of Houston, 9265 Kirby Dr., Houston, TX 77054. NDC 42852-243-63
Lack of Assurance of Sterility: Potential leakage of bags.
2018-07-25FDA-DrugAvella of Deer Valley, Inc. Store 38Class II
MORphine 1 mg/mL (Morphine Sulfate, USP 250mg, 0.9% Sodium Chloride, USP 250 mL). Volume 255 mL. Single dose bag. Avella of Houston, 9265 Kirby Dr., Houston, TX 77054. NDC 42852-241-25
Lack of Assurance of Sterility: Potential leakage of bags.
2018-07-25FDA-DrugAvella of Deer Valley, Inc. Store 38Class II
MAGnesium 2gm in NS 100 mL (MAGnesium SULfate (USP) 2 gm, 0.9% Sodium Chloride (USP) 100 mL). Volume: 104 mL. Single dose bag. For: Desert Regional Med Ctr By: Avella of Houston, 9256 Kirby Dr., Houston, TX 77054. NDC: 42852-907-10
Lack of Assurance of Sterility: Potential leakage of bags.
2018-07-25FDA-DrugAvella of Deer Valley, Inc. Store 38Class II
MAGnesium 1gm in NS 100 mL (MAGnesium SULfate (USP) 1 gm, 0.9% Sodium Chloride (USP) 100 mL). Volume: 102 mL. Single dose bag. For: Salt Lake Regional Med Ctr By: Avella of Houston, 9256 Kirby Dr., Houston, TX 77054. NDC: 42852-906-10
Lack of Assurance of Sterility: Potential leakage of bags.
2018-07-25FDA-DrugAvella of Deer Valley, Inc. Store 38Class II
HYDROmorphone 0.2mg/mL. (Hydromorphone HCL (USP) 20 mg, 0.9% Sodium Chloride (USP) QS 100 mL) Volume: 100mL. Single dose bag. Advanced Pharma, 9265 Kirby Dr., Houston,077054 TX. NDC 15082-221-10
Lack of Assurance of Sterility: Potential leakage of bags.
2018-07-25FDA-DrugAvella of Deer Valley, Inc. Store 38Class II
HYDROmorphone 1 mg/mL (HYDROmorphone HCL (USP) 30 mg, 0.9% Sodium Chloride (USP) QS 30 mL) Volume: 30mL. Single dose syringe. Avella of Houston, 9265 Kirby Dr., Houston, TX. NDC 42852-222-63
Lack of Assurance of Sterility: Potential leakage of bags.
2018-07-25FDA-DrugAvella of Deer Valley, Inc. Store 38Class II
HEPARIN 1,000 Units in NS 250mL. (Heparin Sodium, USP 1,000 Units, 0.9% Sodium Chloride, USP 250 mL) Volume: 251 mL. Single dose bag. For: Adventist Medical Center Hanford. By: Avella of Huston, 9265 Kirby Dr., Houston TX, 77054. NDC 42852-747-25
Lack of Assurance of Sterility: Potential leakage of bags.
2018-07-25FDA-DrugAvella of Deer Valley, Inc. Store 38Class II
HEPARIN 12,500 Units in 5% Dextrose. (Heparin Sodium, USP 12,500 Units, 5% Dextrose Inj., USP 250 mL) Volume: 252.5 mL. Single dose bag. Avella Specialty Pharmacy, 24416 N 19th Avenue Phoenix, AZ 85085. NDC 42852-745-25
Lack of Assurance of Sterility: Potential leakage of bags.
2018-07-25FDA-DrugAvella of Deer Valley, Inc. Store 38Class II
fentaNYL 2 mcg/mL, 0.125% ROPivacaine, Fentanyl Citrate, USP 300 mcg, Ropivacaine HCL PF, USP 187.5 mg, 0.9% Sodium Chloride, USP QS 150 mL. Volume: 150 mL. Single dose cassette For: Methodist Dallas Medical Center. By: Advanced Pharma, 9265 Kirby Dr., Houston, TX 77054. NDC 15082-278-86
Lack of Assurance of Sterility: Potential leakage of bags.
2018-07-25FDA-DrugAvella of Deer Valley, Inc. Store 38Class II
fentaNYL 5 mcg Citrate, USP 5 mcg in 0.9% Sodium Chloride, USP QS 0.5mL. (10 mcg per mL) 5 mcg in 0.5 mL. Volume: 0.5 mL. Single dose syringe. For Cook Children's Med Ctr. By: Advanced Pharma, 9265 Kirby Dr., Houston TX 77054. NDC 15082-210-72
Lack of Assurance of Sterility: Potential leakage of bags.
2018-07-25FDA-DrugAvella of Deer Valley, Inc. Store 38Class II
fentaNYL 3 mcg/mL, 0.1% Bupivacaine, Fentanyl Citrate, USP 750 mcg, Bupivacaine HCL PF, USP, 250 mg, 0.9% Sodium Chloride, USP QS 250 mL. Volume: 250mL. Single dose Cassette. For: Methodist St. John Hospital, By: Advanced Pharma, 9265 Kirby Dr., Houston, TX 77054. NDC 15082-250-87
Lack of Assurance of Sterility: Potential leakage of bags.
2018-07-25FDA-DrugAvella of Deer Valley, Inc. Store 38Class II
ePHEDrine Sulfate, USP 50mg in 0.9% Sodium Chloride USP QS 10mL. 50 mg/10 mL (5 mg/mL). Volume: 10 mL. Single dose syringe. Avella of Houston, 9265 Kirby Dr., Houston, TX 77054. NDC 42852-891-61
Lack of Assurance of Sterility: Potential leakage of bags.
2018-07-25FDA-DrugAvella of Deer Valley, Inc. Store 38Class II
0.2% ROPivacaine, (Ropivacaine HCL PF, USP 500mg, 0.9% Sodium Chloride, USP QS 250 mL). Volume 250 mL. Single dose Cassette. For: Parkland Memorial Hospital. By: Advanced Pharma, 9225 Kirby Dr. Houston, TX 77054. Parkland Memorial Hospital NDC 15082-002-87
Lack of Assurance of Sterility: Potential leakage of bags.
2018-07-25FDA-DrugAvella of Deer Valley, Inc. Store 38Class II
Vancomycin 1.25gm in D5W 250 mL. ( Vancomycin HCL (USP) 1.25 gm, 5% Dextrose Inj. (USP) 250 mL) Volume: 262 mL. Single dose bag. Avella Specialty Pharmacy, 24416N 19th Avenue, Phoenix, AZ 85085. NDC 42852-617-25
Lack of Assurance of Sterility: Potential leakage of bags.
2018-07-25FDA-DrugAvella of Deer Valley, Inc. Store 38Class II
PHENYLephrine 40 mg (PHENYLephrine HCL (USP) 40 mg, 5%Dextrose Inj., USP 250 mL) Volume: 254 mL. Single dose bag. Avella of Houston, 9265 Kirby Dr., Houston, TX 77054. NDC 42852-893-25
Lack of Assurance of Sterility: Potential leakage of bags.
2018-07-25FDA-DrugAvella of Deer Valley, Inc. Store 38Class II
NORepiNEPHrine 8 mg (norepinephrine Bitartrate (USP) 8 mg added to 5% Dextrose Inj. (USP) 250 mL. (Concentration 32 mcg/mL) Volume: 258 mL. Single dose bag. Avella of Houston, 9265 Kirby Dr. Houston, TX 77054. NDC 42852-815-25
Lack of Assurance of Sterility: Potential leakage of bags.
2018-07-25FDA-DrugAvella of Deer Valley, Inc. Store 38Class II
MORphine 1 mg/mL (Morphine Sulfate, USP 100mg, 0.9% Sodium Chloride, USP QS 100 mL). Volume 100 mL. Single dose bag. Avella of Houston, 9265 Kirby Dr., Houston, TX 77054. NDC 42852-241-10
Lack of Assurance of Sterility: Potential leakage of bags.
2018-07-25FDA-DrugAvella of Deer Valley, Inc. Store 38Class II
Midazolam 1 mg/mL (Midazolam HCL (USP) 100 mg, Sodium Chloride, USP QS 100 mL) Volume: 100 mL. Single dose bag. Avella of Houston, 9265 Kirby Dr., Houston TX 77054. NDC 4252-401-10
Lack of Assurance of Sterility: Potential leakage of bags.

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