Class I - Dangerous
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
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Drugs Recalls
Prescription and over-the-counter medications
17,302 Total Recalls
Class I - Dangerous
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class I - Dangerous
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Enalapril Maleate, USP 5MG, 90-count bottle, RX only. Packaged By: Aidarex Pharmaceuticals. Mfg: Wockhardt Ltd. India. NDC: 33261-0693-90
Aidarex Pharmaceuticals
Class I - Dangerous
Out-of-specification results for the Enalapril Diketopiperazine degradation product during commercial stability.
Unit Dose Valsartan Tablets, USP. 160 mg. Rx only.,Distributed by: Major Pharmaceuticals, Livonia, MI 48152, NDC# 0904-6594-61. NDC# 0904-6595-61.
MAJOR PHARMACEUTICALS
Class I - Dangerous
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
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
Avella of Deer Valley, Inc. Store 38
Class I - Dangerous
Lack of Assurance of Sterility: Potential leakage of bags.
fentaNYL (10 mcg per mL) in 0.95 Sodium Chloride, USP QS 1mL. Volume 1mL. Single dose Syringe. For: Hunt Regional Medical Center, By: Advanced Pharma, 9265 Kirby Dr,., Houston, TX 77054. NDC 15082-210-70
Avella of Deer Valley, Inc. Store 38
Class I - Dangerous
Lack of Assurance of Sterility: Potential leakage of bags.
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
Avella of Deer Valley, Inc. Store 38
Class I - Dangerous
Lack of Assurance of Sterility: Potential leakage of bags.
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
Avella of Deer Valley, Inc. Store 38
Class I - Dangerous
Lack of Assurance of Sterility: Potential leakage of bags.
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
Avella of Deer Valley, Inc. Store 38
Class I - Dangerous
Lack of Assurance of Sterility: Potential leakage of bags.
ceFAZolin 2 gm in NS 100mL. ceFAZolin Sodium (USP) 2gm, 0.9% Sodium Chloride (USP) 100mL. Volume 110 mL. Single dose bag. Avella of Houston 9265 Kirby Dr., Houston, TX 77054 NDC: 42852-604-10
Avella of Deer Valley, Inc. Store 38
Class I - Dangerous
Lack of Assurance of Sterility: Potential leakage of bags.
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
Avella of Deer Valley, Inc. Store 38
Class I - Dangerous
Lack of Assurance of Sterility: Potential leakage of bags.
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
Avella of Deer Valley, Inc. Store 38
Class I - Dangerous
Lack of Assurance of Sterility: Potential leakage of bags.
Methyl Folate CA+ 1mg/ml Injection w/Pres. (Benzyl Alcohol 1% in Sterile Water), 10 mL and 30 mL vials, Rx only, la VITA Compounding Pharmacy, 858.453.2500
La Vita Compounding Pharmacy
Class I - Dangerous
Lack of Processing Controls: products produced in a manner that calls into question the sterility of the drug product intended to be sterile.
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
Avella of Deer Valley, Inc. Store 38
Class I - Dangerous
Lack of Assurance of Sterility: Potential leakage of bags.
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
Avella of Deer Valley, Inc. Store 38
Class I - Dangerous
Lack of Assurance of Sterility: Potential leakage of bags.
HEPARIN 25,000 Units in 5% Dextrose (Heparin Sodium, USP 25,000 Units, 5% Dextrose Inj., USP 250 mL) Volume: 255 mL. Single dose bag. Avella Specialty Pharmacy, 24416 N 19th Avenue, Pheonix AZ 85085. NDC 42852-729-25
Avella of Deer Valley, Inc. Store 38
Class I - Dangerous
Lack of Assurance of Sterility: Potential leakage of bags.
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
Avella of Deer Valley, Inc. Store 38
Class I - Dangerous
Lack of Assurance of Sterility: Potential leakage of bags.
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
Avella of Deer Valley, Inc. Store 38
Class I - Dangerous
Lack of Assurance of Sterility: Potential leakage of bags.
Methylcobalamin 1mg/mL Injection w/Pres. (Benzyl Alcohol 1% in Sterile Water), packaged in 10 mL and 30 mL vials, Rx only, la VITA Compounding Pharmacy, 858.453.2500
La Vita Compounding Pharmacy
Class I - Dangerous
Lack of Processing Controls: products produced in a manner that calls into question the sterility of the drug product intended to be sterile.