Drug Recalls

17,680 Records

Prescription & OTC drug enforcement reports

2,152 results found for contamination Page 44 of 87
King Bio Inc.
Class I Terminated
Dr. King's SafeCare Rx Morning Sickness, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive, Asheville, NC 28806 USA, UPC 357955000822, NDC 57955-0008-2
Reason: Microbial contamination
D-0819-2019 March 20, 2019 Asheville, NC
King Bio Inc.
Class I Terminated
Dr. King's SafeCare Rx Allergies: Mold, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive, Asheville, NC 28806 USA, UPC 357955650126, NDC 57955-6501-2
Reason: Microbial contamination
D-0766-2019 March 20, 2019 Asheville, NC
Todd Holiday dba Sunstone Organics
Class I Terminated
Maeng Da Kratom, packaged in a) 25 gram powder (UPC 00859667007118), b) 50 gram powder (UPC 00859667007125), c) 100 gram powder (UPC 00859667007132), Sunstone Organics Springfield, Oregon 97473, 541-...
Reason: MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS: Analysis of samples were positive for Salmonella.
D-0986-2019 March 13, 2019 Springfield, OR
Todd Holiday dba Sunstone Organics
Class I Terminated
White Vein Kratom, packaged in a) 20 count capsules (UPC 00859667007347), b) 60 count capsules (UPC 00859667007354), c) 150 count capsules (UPC 00859667007361), Sunstone Organics Springfield, Oregon ...
Reason: MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS: Analysis of samples were positive for Salmonella.
D-0988-2019 March 13, 2019 Springfield, OR
Todd Holiday dba Sunstone Organics
Class I Terminated
White Vein Kratom, packaged in a) 25 gram powder (UPC 00859667007316), b) 50 gram powder (UPC 00859667007323), c) 100 gram powder (UPC 00859667007330), Sunstone Organics Springfield, Oregon 97473, 541...
Reason: MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS: Analysis of samples were positive for Salmonella.
D-0987-2019 March 13, 2019 Springfield, OR
Todd Holiday dba Sunstone Organics
Class I Terminated
Maeng Da Kratom, packaged in a) 20 count capsules (UPC 00859667007149), b) 60 count capsules (UPC 00859667007156), c) 150 count capsules (UPC 00859667007163) , Sunstone Organics Springfield, Oregon 97...
Reason: MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS: Analysis of samples were positive for Salmonella.
D-0989-2019 March 13, 2019 Springfield, OR
Vi-Jon, Inc.
Class II Terminated
Topical Solution USP Hydrogen Peroxide First Aid Antiseptic Oral Debriding Agent 32 Fl. Oz. (1 QT) 946 mL bottle, Distributed By: Discount Drug Mart 211 Commerce Drive, Medina, Ohio 44256 NDC 53943-87...
Reason: Cross Contamination: Presence of IPA in finished product.
D-0520-2019 March 13, 2019 Smyrna, TN
Mariposa Labs LLC
Class II Terminated
tubby todd Bath Co, 100% NATURAL DREAM CREAM, Shea Butter and Mint, 3.5 FL OZ 99G, Distributed by: Tubby Todd Bath Co. Vista, CA 920, (619) 894-6560.
Reason: Microbial Contamination of Non-Sterile Products: Consumer complaint and subsequent testing found lot to be out of specification for mold.
D-0510-2019 February 27, 2019 Boise, ID
AVKARE Inc.
Class II Terminated
Germ Bloc Health Hand Sanitizer Foam (benzalkonium chloride 0.13%) 7.5fl.oz./222mL refill bags, AvKARE, Inc. Pulaski, TN 38478 www.avkare.com, NDC 5026835427, UPC 3 50268 35408
Reason: Microbial Contamination of Non-Sterile Product: Presence of Pseudomonas aeruginosa in product
D-0285-2019 December 5, 2018 Pulaski, TN
RemedyRepack Inc.
Class III Terminated
Nitrofurantoin Monohydrate/Macrocrystals capsules,100 mg, packaged in HDPE 60 cc bottles, Rx only, MFG: Sandoz Inc., Princeton, NJ, Repackaged by: RemedyRepack, Indiana, PA, Original NDC 00185-0122-01...
Reason: Cross contamination with other products: Product is being recalled due to the potential presence of unrelated ingredients (Benazepril, Haloperidol and Perphenazine).
D-0284-2019 December 5, 2018 Indiana, PA
AMERICAN HEALTH PACKAGING
Class III Terminated
Nitrofurantoin Capsules USP (Monohydrate/Macrocrystals), 100 mg, 100-count Unit Dose Blisters, Rx only, Amerisource Health Services DBA American Health Packaging, 2550-A John Glenn Avenue Columbus, O...
Reason: Cross contamination with other products: This sub-recall is being initiated in support of the recall by the manufacturer (Sandoz) dated 11/1/18, which included lots that were repac...
D-0273-2019 November 28, 2018 Columbus, OH
Sandoz Inc
Class II Terminated
Isosorbide Dinitrate Tablets, USP 5 mg,100-count bottles, Rx Only Manufactured by: Sandoz Inc., Princeton, NJ 08540 For BluePoint Laboratories, NDC 68001-223-00
Reason: Cross Contamination with Other Products
D-0259-2019 November 21, 2018 Princeton, NJ
Sandoz Inc
Class II Terminated
Isosorbide Dinitrate Tablets, USP 20 mg, 100-count bottles, Rx Only, Distributed by: Sandoz Inc. Princeton, NJ 08540; NDC 0781-1695-01
Reason: Cross Contamination with Other Products
D-0258-2019 November 21, 2018 Princeton, NJ
Sandoz Inc
Class II Terminated
Isosorbide Dinitrate Tablets, USP 10 mg,100-count bottles, Rx Only Manufactured by: Sandoz Inc., Princeton, NJ 08540 For BluePoint Laboratories, NDC 68001-225-00
Reason: Cross Contamination with Other Products
D-0260-2019 November 21, 2018 Princeton, NJ
Sandoz Inc
Class II Terminated
Isosorbide Dinitrate Tablets, USP 20 mg,100-count bottles, Rx Only Manufactured by: Sandoz Inc., Princeton, NJ 08540 For BluePoint Laboratories, NDC 68001-222-00
Reason: Cross Contamination with Other Products
D-0261-2019 November 21, 2018 Princeton, NJ
Sandoz Inc
Class III Terminated
Nitrofurantoin Capsules, USP (Monohydrate/Macrocrystals) 100 mg, 100-count bottoles, Rx Only, Manufactured for: Northstar Rx LLC Memphis, TN 38141 Manufactured by: Sandoz Inc. Princeton, NJ 08540,NDC ...
Reason: Cross Contamination with Other Products
D-0262-2019 November 21, 2018 Princeton, NJ
Sandoz Inc
Class III Terminated
Nitrofurantoin Capsules, USP (Monohydrate/Macrocrystals) 100 mg, packaged in a) 100-capsule bottles (NDC 0185-0122-01); and b) 1000-capsule bottles, (NDC 0185-0122-10); Rx Only, Distributed by Sandoz ...
Reason: Cross Contamination with Other Products
D-0257-2019 November 21, 2018 Princeton, NJ
Silver Star Brands
Class I Terminated
Native Remedies HypoSlim Oral Spray, 2 fl oz (59 mL) per bottle, Distributed by: Silver Star Brands, Oshkosh, WI 54906. NDC 68703-275-02
Reason: Microbial Contamination of Non-Sterile Products
D-0252-2019 November 14, 2018 Oshkosh, WI
Silver Star Brands
Class II Terminated
Healthful Naturals Leg Cramp Support Oral Spray, 2 fl oz (59 mL) per bottle, Distributed by: Silver Star Brands, Oshkosh, WI 54906 NDC 68703-206-02
Reason: CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
D-0256-2019 November 14, 2018 Oshkosh, WI
Silver Star Brands
Class I Terminated
Native Remedies EyeClear Pro Oral Spray, 2 fl oz (59 mL) per bottle, Distributed by: Silver Star Brands, Oshkosh, WI 54906. NDC 68703-151-59
Reason: Microbial Contamination of Non-Sterile Product
D-0254-2019 November 14, 2018 Oshkosh, WI
Silver Star Brands
Class I Terminated
Native Remedies VertiFree Oral Spray, 2 fl oz (59 mL) per bottle, Distributed by: Silver Star Brands, Oshkosh, WI 54906. NDC 68703-253-02
Reason: Microbial Contamination of Non-Sterile Products
D-0251-2019 November 14, 2018 Oshkosh, WI
Silver Star Brands
Class II Terminated
Healthful Naturals DizziFree Oral Spray, 2 fl oz (59 mL) per bottle, Distributed by: Silver Star Brands, Oshkosh, WI 54906. NDC 68703-204-02
Reason: CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
D-0255-2019 November 14, 2018 Oshkosh, WI
Medline Industries Inc
Class II Terminated
SparkleFresh Fluoride Toothpaste, Sodium Monofluorophosphate 0.76%, a) 17 g tube (NDC 53329-083-92, product number NONTP6I), b) 24 g tube (NDC 53329-083-93, product number NONTP85I), c) 42.5 g (NDC 53...
Reason: Microbial Contamination of Non-Sterile Product
D-0247-2019 November 14, 2018 Northfield, IL
Silver Star Brands
Class I Terminated
Native Remedies VaricoGo Oral Spray, 2 fl oz (59 mL) per bottle, Distributed by: Silver Star Brands, Oshkosh, WI 54906. NDC 68703-105-59
Reason: Microbial Contamination of Non-Sterile Products
D-0253-2019 November 14, 2018 Oshkosh, WI
Sprayology
Class II Terminated
Snore Soother, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Sprayology Gaithersburg. MD 20879. NDC 61096-0024-1
Reason: CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
D-0118-2019 November 7, 2018 Gaithersburg, MD