July 25, 2018DrugsFDA
La Vita Compounding Pharmacy, LLC recalls Methyl Folate CA+ 1mg/ml Injection w/Pres. (Benzyl Alcohol 1% in Sterile Water), 10 mL and 30 mL vials, Rx only, la VITA
Hazard: Lack of Processing Controls: products produced in a manner that calls into question the sterility of the drug product intended to be sterile.
July 25, 2018DrugsFDA
La Vita Compounding Pharmacy, LLC recalls Methylcobalamin 1mg/mL Injection w/Pres. (Benzyl Alcohol 1% in Sterile Water), packaged in 10 mL and 30 mL vials, Rx onl
Hazard: Lack of Processing Controls: products produced in a manner that calls into question the sterility of the drug product intended to be sterile.
July 25, 2018DrugsFDA
The Hain Celestial Group, Inc. - Worldwide HQ recalls alba BOTANICA sport mineral sunscreen (titanium dioxide 7.0% and zinc oxide 9.0%), spf 45, 170 g (6 oz) tubes packaged i
Hazard: Incorrect Product Formulation: wrong sunscreen product in the package.
July 18, 2018DrugsFDA
AuroMedics Pharma LLC recalls Piperacillin and Tazobactam for Injection USP 3.375 grams per vial, Single-Dose Vial, Rx Only. Manufactured for: Auromed
Hazard: Presence of Particulate Matter: identified as glass and silicone material
July 18, 2018DrugsFDA
Gaia Ethnobotanical LLC recalls Gaia Kratom (mitragyna speciosa) powder, Yellow Vietnam, 1oz, 250g, 1kg packages, Gaia Ethnobotanical.com
Hazard: Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination
July 18, 2018DrugsFDA
Gaia Ethnobotanical LLC recalls Gaia Kratom (mitragyna speciosa) powder, Yellow Thai, 1oz, 250g, 1kg packages, Gaia Ethnobotanical.com
Hazard: Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination
July 18, 2018DrugsFDA
Gaia Ethnobotanical LLC recalls Gaia Kratom (mitragyna speciosa) powder, White Thai, 1oz, 250g, 1kg packages, Gaia Ethnobotanical.com
Hazard: Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination
July 18, 2018DrugsFDA
Gaia Ethnobotanical LLC recalls Gaia Kratom (mitragyna speciosa) powder, White MD, 1oz, 250g, 1kg packages, Gaia Ethnobotanical.com
Hazard: Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination
July 18, 2018DrugsFDA
Gaia Ethnobotanical LLC recalls Gaia Kratom (mitragyna speciosa) powder, White Horn, 1oz, 250g, 1kg packages, Gaia Ethnobotanical.com
Hazard: Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination
July 18, 2018DrugsFDA
Gaia Ethnobotanical LLC recalls Gaia Kratom (mitragyna speciosa) powder, White Borneo, 1oz, 250g, 1kg packages, Gaia Ethnobotanical.com
Hazard: Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination
July 18, 2018DrugsFDA
Gaia Ethnobotanical LLC recalls Gaia Kratom (mitragyna speciosa) powder, Red MD, 1oz, 250g, 1kg packages, Gaia Ethnobotanical.com
Hazard: Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination
July 18, 2018DrugsFDA
Gaia Ethnobotanical LLC recalls Gaia Kratom (mitragyna speciosa) powder, Red Kapuas Hulu , 1oz, 250g, 1kg packages, Gaia Ethnobotanical.com
Hazard: Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination
July 18, 2018DrugsFDA
Gaia Ethnobotanical LLC recalls Gaia Kratom (mitragyna speciosa) powder, Red Horn, 1oz, 250g, 1kg packages, Gaia Ethnobotanical.com
Hazard: Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination
July 18, 2018DrugsFDA
Gaia Ethnobotanical LLC recalls Gaia Kratom (mitragyna speciosa) powder, Red Dragon, 1oz, 250g, 1kg packages, Gaia Ethnobotanical.com
Hazard: Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination
July 18, 2018DrugsFDA
Gaia Ethnobotanical LLC recalls Gaia Kratom (mitragyna speciosa) powder, Red Borneo, 1oz, 250g, 1kg packages, Gaia Ethnobotanical.com
Hazard: Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination
July 18, 2018DrugsFDA
Gaia Ethnobotanical LLC recalls Gaia Kratom (mitragyna speciosa) powder, Red Bali, 1oz, 250g, 1kg packages, Gaia Ethnobotanical.com Gaia Ethnob
Hazard: Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination
July 18, 2018DrugsFDA
Gaia Ethnobotanical LLC recalls Gaia Kratom (mitragyna speciosa) powder, Purple 8-1, 1oz, 250g, 1kg packages, Gaia Ethnobotanical.com
Hazard: Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination
July 18, 2018DrugsFDA
Gaia Ethnobotanical LLC recalls Gaia Kratom (mitragyna speciosa) powder, Plantation White MD, 1oz, 250g, 1kg packages, Gaia Ethnobotanical.com
Hazard: Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination
July 18, 2018DrugsFDA
Gaia Ethnobotanical LLC recalls Gaia Kratom (mitragyna speciosa) powder, Plantation Red MD, 1oz, 250g, 1kg packages, Gaia Ethnobotanical.com
Hazard: Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination
July 18, 2018DrugsFDA
Gaia Ethnobotanical LLC recalls Gaia Kratom (mitragyna speciosa) powder, Green Thai, 1oz, 250g, 1kg packages, Gaia Ethnobotanical.com
Hazard: Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination
July 18, 2018DrugsFDA
Gaia Ethnobotanical LLC recalls Gaia Kratom (mitragyna speciosa) powder, Green MD, 1oz, 250g, 1kg packages, Gaia Ethnobotanical.com
Hazard: Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination
July 18, 2018DrugsFDA
Gaia Ethnobotanical LLC recalls Gaia Kratom (mitragyna speciosa) powder, Green Malay, 1oz, 250g, 1kg packages, Gaia Ethnobotanical.com
Hazard: Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination
July 18, 2018DrugsFDA
Gaia Ethnobotanical LLC recalls Gaia Kratom (mitragyna speciosa) powder, Green Kapuas Hulu, 1oz, 250g, 1kg packages, Gaia Ethnobotanical.com
Hazard: Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination
July 18, 2018DrugsFDA
Gaia Ethnobotanical LLC recalls Gaia Kratom (mitragyna speciosa) powder, Green Horn, 1oz, 250g, 1kg packages, Gaia Ethnobotanical.com
Hazard: Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination
July 18, 2018DrugsFDA
Gaia Ethnobotanical LLC recalls Gaia Kratom (mitragyna speciosa) powder, Green Dragon, 1oz, 250g, 1kg packages, Gaia Ethnobotanical.com
Hazard: Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination
July 18, 2018DrugsFDA
Gaia Ethnobotanical LLC recalls Gaia Kratom (mitragyna speciosa) powder, Ganesh, 1oz, 250g, 1kg packages, Gaia Ethnobotanical.com
Hazard: Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination
July 18, 2018DrugsFDA
Gaia Ethnobotanical LLC recalls Gaia Kratom (mitragyna speciosa) powder, Elephant, 1oz, 250g, 1kg packages, Gaia Ethnobotanical.com
Hazard: Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination
July 18, 2018DrugsFDA
Gaia Ethnobotanical LLC recalls Gaia Kratom (mitragyna speciosa) powder, Bali Gold, 1oz, 250g 1kg packages, Gaia Ethnobotanical.com
Hazard: Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination
July 18, 2018DrugsFDA
Mylan Pharmaceuticals Inc. recalls Triamterene and Hydrochlorothiazide Tablets, USP 37.5 mg/25 mg, 100-count bottle, Rx only, Mylan Pharmaceuticals, Inc. M
Hazard: Subpotent Drug
July 18, 2018DrugsFDA
LUPIN SOMERSET recalls Nitrofurantoin Oral Suspension USP, 25mg/5mL, 230 mL Bottle, Rx Only, Manufactured by: Novel Laboratories, Inc. Somerset
Hazard: Subpotent Drug and Failed Content Uniformity.