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.
- 2018-07-25FDA-DrugAvella of Deer Valley, Inc. Store 38Class IIMAGnesium 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 IIMAGnesium 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 IIHYDROmorphone 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 IIHYDROmorphone 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 IIHEPARIN 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 IIHEPARIN 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 IIfentaNYL 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 IIfentaNYL 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 IIfentaNYL 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 IIePHEDrine 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 II0.2% 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 IIVancomycin 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 IIPHENYLephrine 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 IINORepiNEPHrine 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 IIMORphine 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 IIMidazolam 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.
- 2018-07-25FDA-DrugAvella of Deer Valley, Inc. Store 38Class IIMAGnesium 4gm in NS 100 mL (MAGnesium SULfate (USP) 4 gm, 0.9% Sodium Chloride (USP) 100 mL). Volume: 108 mL. Single dose bag. For: Gaston Memorial Hospital By: Avella of Houston, 9256 Kirby Dr., Houston, TX 77054. NDC: 42852-905-10
Lack of Assurance of Sterility: Potential leakage of bags.
- 2018-07-25FDA-DrugAvella of Deer Valley, Inc. Store 38Class IIHYDROmorphone 1 mg/mL (HYDROmorphone HCL (USP) 50 mg, 0.9% Sodium Chloride (USP) QS 50 mL) Volume: 50mL. Single dose syringe. Avella of Houston, 9265 Kirby Dr., Houston, TX. NDC 42852-222-65
Lack of Assurance of Sterility: Potential leakage of bags.
- 2018-07-25FDA-DrugAvella of Deer Valley, Inc. Store 38Class IIHEPARIN 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
Lack of Assurance of Sterility: Potential leakage of bags.
- 2018-07-25FDA-DrugAvella of Deer Valley, Inc. Store 38Class IIfentaNYL (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
Lack of Assurance of Sterility: Potential leakage of bags.
- 2018-07-25FDA-DrugAvella of Deer Valley, Inc. Store 38Class IIEPINEPHrine (USP) 4 mg, 0.9% Sodium Chloride (USP) 250 mL Volume: 254 mL single dose bag. Avella of Houston, 9265 Kirby Dr., Houston, TX 77054. NDC 42852-823-25.
Lack of Assurance of Sterility: Potential leakage of bags.
- 2018-07-25FDA-DrugAvella of Deer Valley, Inc. Store 38Class IIEPINEPHrine (USP) 4 mg, 5% Dextrose For Inj. (USP) 250 mL Volume: 254 mL single dose bag. For: Peninsular Regional Medical Center. By: Advanced Pharma, 9265 Kirby Dr., Houston, TX 77054. NDC 15082-855-25.
Lack of Assurance of Sterility: Potential leakage of bags.
- 2018-07-25FDA-DrugAvella of Deer Valley, Inc. Store 38Class IIePHEDrine 50mg, 50 mg/10 mL (5 mg per mL) (Ephedrine Sulfate, USP 50mg in 0.9% Sodium Chloride, USPQS 10mL. 10 mL-Sterile use dose syringe. Avella of Houston, 9265 Kirby Dr., Houston, TX 77054 NDC 42852-805-61
Lack of Assurance of Sterility: Potential leakage of bags.
- 2018-07-25FDA-DrugAvella of Deer Valley, Inc. Store 38Class IIceFAZolin 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
Lack of Assurance of Sterility: Potential leakage of bags.
- 2018-07-25FDA-DrugAvella of Deer Valley, Inc. Store 38Class II0.2% ROPivacaine - OnQ Pump, (ROPivacaine HCL (USP) 1100mg, 0.9% Sodium Chloride (USP) QS 550 ml, single dose pump. For: Vidant Medical Center, By: Avella of Houston, 9265 Kirby Dr., Houston, TX 77056. NDC: 42852-661-02
Lack of Assurance of Sterility: Potential leakage of bags.
- 2018-07-25FDA-DrugSun Pharmaceutical Industries, Inc.Class IIMetformin Hydrochloride Extended Release Tablets, USP, 500 mg, packaged in a 500-count bottle, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd. Halol-Baroda Highway, Halol-389 350 Gujarat. India, NDC 62756-142-02
Presence of foreign substance: One lot fo Metformin Hydrochloride Extended Release Tablets, USP, 500 mg (500 Count) contains foreign matter identified as a piece of rubber glove detected in one tablet.
- 2018-07-25FDA-DrugLa Vita Compounding Pharmacy, LLCClass IIGlutathione 200mg/mL Injection w/Pres. (Benzyl Alcohol 1.5% in Sterile Water), 30 mL vial, Rx only, la VITA Compounding Pharmacy, 858.453.2500
Lack of Processing Controls: products produced in a manner that calls into question the sterility of the drug product intended to be sterile.
- 2018-07-25FDA-DrugLa Vita Compounding Pharmacy, LLCClass IIMethyl 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
Lack of Processing Controls: products produced in a manner that calls into question the sterility of the drug product intended to be sterile.
- 2018-07-25FDA-DrugLa Vita Compounding Pharmacy, LLCClass IIMethylcobalamin 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
Lack of Processing Controls: products produced in a manner that calls into question the sterility of the drug product intended to be sterile.
- 2018-07-25FDA-DrugThe Hain Celestial Group, Inc. - Worldwide HQClass IIalba BOTANICA sport mineral sunscreen (titanium dioxide 7.0% and zinc oxide 9.0%), spf 45, 170 g (6 oz) tubes packaged in a) 4 tubes per case; b) 8 pack shipper display; Manufactured By: The Hain Celestial Group, Inc., Lake Success, NY 11042, UPC 7 24742 01102 4.
Incorrect Product Formulation: wrong sunscreen product in the package.
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