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.
- 2018-07-18FDA-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
- 2018-07-18FDA-DrugGaia Ethnobotanical LLCClass IGaia Kratom (mitragyna speciosa) powder, Green 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, Green 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, Green Malay, 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, Green 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, Green 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, Green 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, Ganesh, 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, Elephant, 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, Bali Gold, 1oz, 250g 1kg packages, Gaia Ethnobotanical.com
Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination
- 2018-07-18FDA-DrugMylan Pharmaceuticals Inc.Class IIITriamterene and Hydrochlorothiazide Tablets, USP 37.5 mg/25 mg, 100-count bottle, Rx only, Mylan Pharmaceuticals, Inc. Morgantown, WV 26505, NDC 0378-1352-01
Subpotent Drug
- 2018-07-18FDA-DrugLUPIN SOMERSETClass IINitrofurantoin Oral Suspension USP, 25mg/5mL, 230 mL Bottle, Rx Only, Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202, UPC 343386-450-114, NDC 43386-450-11
Subpotent Drug and Failed Content Uniformity.
- 2018-07-18FDA-DrugSanofi-Aventis U.S. LLCClass IIAdmelog Solostar (insulin lispro injection), 100 units/ mL (U-100) injection, packaged in 3mL prefilled pens, 1 pen per box, Rx only, Physician Sample - Not For Sale, Sanofi-Aventis U.S. LLC, Bridgewater, NJ 08807, NDC 0024-5925-00
Temperature Abuse: Product samples of Admelog may not have been shipped at proper temperature.
- 2018-07-18FDA-DrugMedi-Fare Drug and Home Health CenterClass IIPotassium Chloride For Injection Concentrate syringe 40 mEq/20 mL (2 mEq/mL), Rx only, Medi-Fare Drug Pharmaceutical Compounding 300 West Pine St., Blacksburg, SC 29702 800-622-0007
CGMP Deviations: Syringes were filled with 19mL of potassium chloride when the labels displayed a fill of 20mL.
- 2018-07-18FDA-DrugSCA PharmaceuticalsClass IIBuffered Lidocaine 1% with Sodium Bicarbonate Injection for Local Anesthetic Use (Concentration=10 mg/mL) 0.25 mL Total Volume, Rx only , SCA Pharmaceuticals, 8821 Knoedl Ct. Little Rock, AR 72205 877-550-5059
Subpotent Drug: Stability data does not support the current expiration dating of 55 days after compounding.
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