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.
- 2018-07-25FDA-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.
- 2018-07-18FDA-DrugAuroMedics Pharma LLCClass IPiperacillin and Tazobactam for Injection USP 3.375 grams per vial, Single-Dose Vial, Rx Only. Manufactured for: Auromedics Pharma LLC 6 Wheeling Road Dayton NJ 08810, Made in India. NDC 55150-120-30
Presence of Particulate Matter: identified as glass and silicone material
- 2018-07-18FDA-DrugGaia Ethnobotanical LLCClass IGaia Kratom (mitragyna speciosa) powder, Yellow Vietnam, 1oz, 250g, 1kg packages, Gaia Ethnobotanical.com
Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination
- 2018-07-18FDA-DrugGaia Ethnobotanical LLCClass IGaia Kratom (mitragyna speciosa) powder, Yellow Thai, 1oz, 250g, 1kg packages, Gaia Ethnobotanical.com
Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination
- 2018-07-18FDA-DrugGaia Ethnobotanical LLCClass IGaia Kratom (mitragyna speciosa) powder, White Thai, 1oz, 250g, 1kg packages, Gaia Ethnobotanical.com
Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination
- 2018-07-18FDA-DrugGaia Ethnobotanical LLCClass IGaia Kratom (mitragyna speciosa) powder, White MD, 1oz, 250g, 1kg packages, Gaia Ethnobotanical.com
Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination
- 2018-07-18FDA-DrugGaia Ethnobotanical LLCClass IGaia Kratom (mitragyna speciosa) powder, White Horn, 1oz, 250g, 1kg packages, Gaia Ethnobotanical.com
Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination
- 2018-07-18FDA-DrugGaia Ethnobotanical LLCClass IGaia Kratom (mitragyna speciosa) powder, White Borneo, 1oz, 250g, 1kg packages, Gaia Ethnobotanical.com
Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination
- 2018-07-18FDA-DrugGaia Ethnobotanical LLCClass IGaia Kratom (mitragyna speciosa) powder, Red MD, 1oz, 250g, 1kg packages, Gaia Ethnobotanical.com
Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination
- 2018-07-18FDA-DrugGaia Ethnobotanical LLCClass IGaia Kratom (mitragyna speciosa) powder, Red Kapuas Hulu , 1oz, 250g, 1kg packages, Gaia Ethnobotanical.com
Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination
- 2018-07-18FDA-DrugGaia Ethnobotanical LLCClass IGaia Kratom (mitragyna speciosa) powder, Red Horn, 1oz, 250g, 1kg packages, Gaia Ethnobotanical.com
Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination
- 2018-07-18FDA-DrugGaia Ethnobotanical LLCClass IGaia Kratom (mitragyna speciosa) powder, Red Dragon, 1oz, 250g, 1kg packages, Gaia Ethnobotanical.com
Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination
- 2018-07-18FDA-DrugGaia Ethnobotanical LLCClass IGaia Kratom (mitragyna speciosa) powder, Red Borneo, 1oz, 250g, 1kg packages, Gaia Ethnobotanical.com
Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination
- 2018-07-18FDA-DrugGaia Ethnobotanical LLCClass IGaia Kratom (mitragyna speciosa) powder, Red Bali, 1oz, 250g, 1kg packages, Gaia Ethnobotanical.com Gaia Ethnobotanical Red Borneo, 1oz, 250g, kg Gaia Ethnobotanical Red Dragon, 1oz, 250g, 1kg Gaia Ethnobotanical Red Horn, 1oz, 250g, 1kg Gaia Ethnobotanical Red Kapuas Hulu 1oz, 250g, 1kg Gaia Ethnobotanical Red MD, 1oz, 250g, 1kg Gaia Ethnobotanical Red Thai, 1oz, 250g,. 1kg Gaia Ethnobotanical Super Green Malay 1oz, 250g, 1kg Gaia Ethnobotanical White Borneo 1oz, 250g, 1kg Gai
Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination
- 2018-07-18FDA-DrugGaia Ethnobotanical LLCClass IGaia Kratom (mitragyna speciosa) powder, Purple 8-1, 1oz, 250g, 1kg packages, Gaia Ethnobotanical.com
Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination
- 2018-07-18FDA-DrugGaia Ethnobotanical LLCClass IGaia Kratom (mitragyna speciosa) powder, Plantation White MD, 1oz, 250g, 1kg packages, Gaia Ethnobotanical.com
Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination
- 2018-07-18FDA-DrugGaia Ethnobotanical LLCClass IGaia Kratom (mitragyna speciosa) powder, Plantation Red MD, 1oz, 250g, 1kg packages, Gaia Ethnobotanical.com
Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination
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