Drug Recalls

17,680 Records

Prescription & OTC drug enforcement reports

2,152 results found for contamination Page 46 of 87
Product Quest Manufacturing LLC
Class II Terminated
Mushatt's No. 9, PsoriWash Medicated Wash, Salicylic Acid 1.8%, 8 oz. (226 g) tube, Distributed by Mushatts, LLC, P.O. Box 372476, Satellite Beach, FL 32937, UPC 8 58245 00203 3.
Reason: Microbial Contamination of Non-Sterile Products and Subpotent Drug: failure for microbiological growth exceeding specification and low out of specification assay results for salicy...
D-0072-2019 October 24, 2018 Daytona Beach, FL
Product Quest Manufacturing LLC
Class II Terminated
DERMATONE (titanium oxide 6% and zinc oxide 4.7%) No-Touch Sunscreen Stick, SPF 50, Net Wt. 0.49 oz. (13.9g) stick, Distributed by: Beaumont Products, Inc. Kennesaw, GA 30144, UPC 0 20908 05100 3.
Reason: Microbial Contamination of Non-Sterile Products: sample tested positive for Staphylococcus aureus.
D-0027-2019 October 24, 2018 Daytona Beach, FL
Product Quest Manufacturing LLC
Class I Terminated
Sinus Relief (oxymetazoline HCl) Nasal decongestant, 0.05%, 0.5 FL OZ (15 mL) bottle, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, UPC 0 50428 43236 5.
Reason: Microbial Contamination of Non-Sterile Products: Failed microbiological testing for Pseudomonas aeruginosa.
D-0074-2019 October 24, 2018 Daytona Beach, FL
BioLyte Laboratories, LLC
Class II Terminated
NeoRelief for Muscle Cramping & Restlessness Homeopathic Topical Gel, packaged in a) 4 ml sample packs and b) Net Wt. 2.0 oz (56.7g) bottles, BioLyte Laboratories - Grand Rapids, MI 49534, NDC 58368-0...
Reason: CGMP Deviations: finished product produced with active ingredients recalled by the manufacturer, King Bio Inc., due to water contamination issues that could potentially affect the ...
D-0002-2019 October 10, 2018 Grand Rapids, MI
Boehringer Ingelheim Pharmaceuticals, Inc.
Class II Terminated
Synjardy (empagliflozin and metformin hydrochloride) Tablets. 5 mg/1000 mg. Rx only. 180-count bottle. Distributed by: Boehinger Ingelheim (BI) Pharmaceuticals, Inc. Ridgefield, CT 06877. Made in Ger...
Reason: Cross Contamination With Other Products:
D-1217-2018 October 3, 2018 Ridgefield, CT
Beaumont Bio-med, Inc.
Class II Terminated
Skin Irritation & Itch Response Homeopathic Formula, 2 FL. OZ. (59.2 mL) per amber glass oral spray bottle, Distributed by Beaumont Bio-Med, Inc., Waukon, IA 52172; NDC 58066-7002-7
Reason: CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
D-1192-2018 September 26, 2018 Waukon, IA
Beaumont Bio-med, Inc.
Class II Terminated
Muscle & Joint Pain Relief Homeopathic Formula, 2 FL. OZ. (59.2 mL) per amber glass oral spray bottle, Distributed by Beaumont Bio-Med, Inc., Waukon, IA 52172; NDC 58066-7041-7
Reason: CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
D-1196-2018 September 26, 2018 Waukon, IA
Beaumont Bio-med, Inc.
Class II Terminated
Colds & Flu Response Homeopathic Formula, 2 FL. OZ. (59.2 mL) per amber glass oral spray bottle, Distributed by Beaumont Bio-Med, Inc., Waukon, IA 52172; NDC 58066-7012-7
Reason: CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
D-1198-2018 September 26, 2018 Waukon, IA
Beaumont Bio-med, Inc.
Class II Terminated
Sore Throat & Laryngitis Response Homeopathic Formula, 2 FL. OZ. (59.2 mL) per amber glass oral spray bottle, Distributed by Beaumont Bio-Med, Inc., Waukon, IA 52172; NDC 58066-7014-7
Reason: CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
D-1194-2018 September 26, 2018 Waukon, IA
Beaumont Bio-med, Inc.
Class II Terminated
Arthritis Pain Relief Homeopathic Formula, 2 FL. OZ. (59.2 mL) per amber glass oral spray bottle, Distributed by Beaumont Bio-Med, Inc., Waukon, IA 52172; NDC 58066-7042-7
Reason: CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
D-1199-2018 September 26, 2018 Waukon, IA
Beaumont Bio-med, Inc.
Class II Terminated
Diarrhea Response Homeopathic Formula, 2 FL. OZ. (59.2 mL) per amber glass oral spray bottle, Distributed by Beaumont Bio-Med, Inc., Waukon, IA 52172; NDC 58066-7022-7
Reason: CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
D-1195-2018 September 26, 2018 Waukon, IA
Beaumont Bio-med, Inc.
Class II Terminated
Sinus Response Homeopathic Formula, 2 FL. OZ. (59.2 mL) per amber glass oral spray bottle, Distributed by Beaumont Bio-Med, Inc., Waukon, IA 52172; NDC 58066-7013-7
Reason: CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
D-1193-2018 September 26, 2018 Waukon, IA
Beaumont Bio-med, Inc.
Class II Terminated
Allergy & Hay Fever Relief Homeopathic Formula, 2 FL. OZ. (59.2 mL) per amber glass oral spray bottle, Distributed by Beaumont Bio-Med, Inc., Waukon, IA 52172; NDC 58066-7011-7
Reason: CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
D-1197-2018 September 26, 2018 Waukon, IA
Hellolife
Class I Terminated
Compulsin, Homeopathic (OTC Medicine), 2 fl oz (59 mL) per bottle, Mftd for: HelloLife, Inc. 4635 40th St SE, Grand Rapids, MI 49512. NDC: 49726-034-02
Reason: Microbial Contamination of Non Sterile Products; Products contaminated with microoganisms, including but not limited to Staphylococcus saprophyticus and Burkholderia cepacia
D-1200-2018 September 19, 2018 Grand Rapids, MI
Hellolife
Class I Terminated
Neuroveen, Homeopathic (OTC Medicine), 2 fl oz (59 mL) per bottle, Mftd for: HelloLife, Inc. 4635 40th St SE, Grand Rapids, MI 49512. NDC: 49726-015-02
Reason: Microbial Contamination of Non Sterile Products; Products contaminated with microoganisms, including but not limited to Staphylococcus saprophyticus and Burkholderia cepacia
D-1201-2018 September 19, 2018 Grand Rapids, MI
Hellolife
Class I Terminated
Respitrol, Homeopathic (OTC Medicine), 2 fl oz (59 mL) per bottle, Mftd for: HelloLife, Inc. 4635 40th St SE, Grand Rapids, MI 49512. NDC: 49726-003-02
Reason: Microbial Contamination of Non Sterile Products; Products contaminated with microoganisms, including but not limited to Staphylococcus saprophyticus and Burkholderia cepacia
D-1203-2018 September 19, 2018 Grand Rapids, MI
Hellolife
Class I Terminated
Thyroveev, Homeopathic (OTC Medicine), 2 fl oz (59 mL) per bottle, Mftd for: HelloLife, Inc. 4635 40th St SE, Grand Rapids, MI 49512. NDC: 49726-025-02
Reason: Microbial Contamination of Non Sterile Products; Products contaminated with microoganisms, including but not limited to Staphylococcus saprophyticus and Burkholderia cepacia
D-1202-2018 September 19, 2018 Grand Rapids, MI
Living Well Remedies, LLC
Class I Terminated
Living Well Remedies Weight Away Remedy, 2 fl oz (59 mL) Distributed by Living Well Remedies, LLC P.O. Box 704, Franklin Lakes, NJ 07417 www.LivingWellRemedies.com. Made in the USA
Reason: Microbial Contamination of Non-Sterile Products: Weight Away Remedy is being recall due to out of specification microbial results.
D-0004-2019 September 5, 2018 Franklin Lakes, NJ
The Hain Celestial Group, Inc. - Worldwide HQ
Class II Terminated
alba BOTANICA Sensitive Sheer Shield Sunscreen Fragrance Free spf 50+ , 85 g 3 oz tube. Manufactured by: The Haine Celestial Group, Inc. Lake Success, NY, UPC 7 24742 00438 5
Reason: Microbial Contamination of a Non-Sterile Product
D-1078-2018 August 22, 2018 New Hyde Park, NY
World Organix, LLC
Class I Terminated
Blissful Remedies Red Maeng Da Liquid Kratom Mitragyna Speciosa, 12mL bottle. Distributed by World Organix LLC Las Vegas Nevada. UPC#7 14983 56525 7
Reason: Microbial Contamination of Non-Sterile Products: The firm is initiating a recall of some of its products due to the potential of high microbial loads.
D-1124-2018 August 15, 2018 Las Vegas, NV
World Organix, LLC
Class I Terminated
Blissful Remedies Kratom+CBD CBD infused Maeng Da, capsules 50-count packaged in While Foil Pouch. Dist. by World Organix LLC, Las Vegas Nevada UPC# 7 11583 27057 4
Reason: Microbial Contamination of Non-Sterile Products: The firm is initiating a recall of some of its products due to the potential of high microbial loads.
D-1126-2018 August 15, 2018 Las Vegas, NV
World Organix, LLC
Class I Terminated
Blissful Remedies Gold Series Ultra Enhanced Indo, 50 capsule, packaged in While Foil Pouch, Dist. by World Organix LLC, Las Vegas Nevada UPC# 6 02401 88900 2
Reason: Microbial Contamination of Non-Sterile Products: The firm is initiating a recall of some of its products due to the potential of high microbial loads.
D-1125-2018 August 15, 2018 Las Vegas, NV
World Organix, LLC
Class I Terminated
Blissful Remedies Red Maeng Da, 100% Mitragyna Speciosa capsule, 50-count packaged White Foil Pouche, Dist. by World Organix LLC, Las Vegas, Nevada UPC#7 22589 32355 3
Reason: Microbial Contamination of Non-Sterile Products: The firm is initiating a recall of some of its products due to the potential of high microbial loads.
D-1122-2018 August 15, 2018 Las Vegas, NV
World Organix, LLC
Class I Terminated
Blissful Remedies, 4 Hour Chill, Slow Motion Blend, Herbal Shot. 1.93 Fluid Oz (57ml) UPC#6 02401 88900 3.
Reason: Microbial Contamination of Non-Sterile Products: The firm is initiating a recall of some of its products due to the potential of high microbial loads.
D-1123-2018 August 15, 2018 Las Vegas, NV
PFIZER
Class II Terminated
Daptomycin for Injection, 500 mg per vial, packaged as 1 Single-dose vial per carton, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-0106-01.
Reason: Microbial Contamination of Sterile Products: Product associated with reports of adverse events indicative of infusion reactions related to microbiological contamination.
D-1023-2018 August 8, 2018 Lake Forest, IL