FDA Recall
TerminatedTerminated: June 4, 2020Historical recordClass II
Testosterone 25 mg pellet, 1 count (NDC: 69761-125-01) and 30 count vials (NDC: 69761-125-30), Rx Only Qualgen, LLC, Edmond, OK 73013
by Qualgen, LLC
- Reason
- Lack of Assurance of Sterility
- Published
- November 14, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: June 4, 2020Historical recordClass II
Testosterone 100mg pellet, 1 count (NDC 69761-110-01), 6 count (NDC 69761-110-06), 12 count (NDC 69761-110-12), and 30 count (NDC 69761-110-30) vials, Rx Only Qualgen, LLC, Edmond, OK 73013
by Qualgen, LLC
- Reason
- Lack of Assurance of Sterility
- Published
- November 14, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: June 4, 2020Historical recordClass II
Estradiol 15mg pellet, 1 count (NDC 69761-015-01), 6 count (NDC 69761-015-06), 12 count (NDC 69761-015-12), and 30 count (NDC 69761-015-30) vials, Rx Only, Qualgen, LLC, Edmond, OK 73013
by Qualgen, LLC
- Reason
- Lack of Assurance of Sterility
- Published
- November 14, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: June 4, 2020Historical recordClass II
Estradiol 12.5mg pellet, 1 count (NDC 69761-012-01), 6 count (NDC 69761-012-06), 12 count (NDC 69761-012-12), and 30 count (NDC 69761-012-30) vials, Rx Only, Qualgen, LLC, Edmond, OK 73013
by Qualgen, LLC
- Reason
- Lack of Assurance of Sterility
- Published
- November 14, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: August 12, 2022Historical recordClass III
Metoprolol Tartrate Injection, USP, 5 mg/ 5 mL (1 mg/mL), 5 mL per sterile single use glass vial, Rx Only, Manufactured for: Claris Lifesciences, Inc., North Brunswick, NJ 08902. By: Claris Injectables Ltd., Gujarat, India. NDC: 36000-033-10
by Baxter Healthcare Corporation
- Reason
- Failed pH Specifications: Upward shift in the pH of the solution within the shelf life of the impacted lots.
- Published
- November 14, 2018
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: October 30, 2019Historical recordClass II
Ortho-Novum 1/35 (norethindrone/ethinyl estradiol) Tablets, 1 mg/0.035 mg, 28-Day Regimen per pouch (NDC 50458-176-28), 6 Veridate Tablet Dispensers and 6 refills per carton (NDC 50458-176-06), Rx only, Manufactured by: Janssen Ortho, LLC, Manati, Puerto Rico 00674; Manufactured for: Janssen Pharmaceuticals, Inc., Titusville, New Jersey 08560.
by Janssen Pharmaceuticals, Inc.
- Reason
- Labeling: Incorrect Instructions; Instructions included for use with the Veridate dispenser contained instructions for the Dialpak dispenser.
- Published
- November 14, 2018
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: March 8, 2021Historical recordClass II
0.9% Sodium Chloride Injection, USP Rx Only a) 250 mL NDC 0409-7983-02; b) 150 mL NDC 0409-7983-61; c) 50 mL NDC 0409-7984-36; d) 100 mL NDC 0409-7984-37, Hospira, Inc. Lake Forest, IL 60045
by ICU Medical Inc
- Reason
- Lack of Assurance of Sterility; bags have the potential to leak
- Published
- November 14, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: March 8, 2021Historical recordClass II
5% Dextrose Injection, USP, Rx Only, a) 25 mL NDC 0409-7923-20; b) 250 mL NDC 0409-7922-02, Hospira, Inc. Lake Forest, IL 60045
by ICU Medical Inc
- Reason
- Lack of Assurance of Sterility; bags have the potential to leak
- Published
- November 14, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: May 20, 2020Historical recordClass II
Request Foods Incorporated
- Product
- Gordon Choice / GFS Vegetable Egg & Cheese Frittata 60oz. U…
- Reason
- The firm was notified by their supplier that ingredients used in their products were possibly contaminated with Listeria monocytogenes and Salmonella.
- Published
- November 14, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: May 20, 2020Historical recordClass II
Request Foods Incorporated
- Product
- Beecher's Mariachi Mac & Cheese 20oz. UPC 82045 11274 Froz…
- Reason
- The firm was notified by their supplier that ingredients used in their products were possibly contaminated with Listeria monocytogenes and Salmonella.
- Published
- November 14, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: May 20, 2020Historical recordClass II
Request Foods Incorporated
- Product
- Love The Wild Hawaiian Style Tropical Bowl with Barramundi 9…
- Reason
- The firm was notified by their supplier that ingredients used in their products were possibly contaminated with Listeria monocytogenes and Salmonella.
- Published
- November 14, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: May 20, 2020Historical recordClass II
Request Foods Incorporated
- Product
- Jenny Craig Butternut Squash Ravioli 213g. UPC 55447 10625…
- Reason
- The firm was notified by their supplier that ingredients used in their products were possibly contaminated with Listeria monocytogenes and Salmonella.
- Published
- November 14, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: May 20, 2020Historical recordClass II
Request Foods Incorporated
- Product
- Moe's Southwest Vegetarian Breakfast Bowl 8oz. UPC 38000 17…
- Reason
- The firm was notified by their supplier that ingredients used in their products were possibly contaminated with Listeria monocytogenes and Salmonella.
- Published
- November 14, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: May 20, 2020Historical recordClass II
Request Foods Incorporated
- Product
- Kashi, Pesto Chickpea Quinoa Bowl 9oz. UPC 18627 10771 Fro…
- Reason
- The firm was notified by their supplier that ingredients used in their products were possibly contaminated with Listeria monocytogenes and Salmonella.
- Published
- November 14, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: May 20, 2020Historical recordClass II
Request Foods Incorporated
- Product
- Kashi, Black Bean Mango Bowl 10oz. UPC 18627 10607 Frozen…
- Reason
- The firm was notified by their supplier that ingredients used in their products were possibly contaminated with Listeria monocytogenes and Salmonella.
- Published
- November 14, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: May 20, 2020Historical recordClass II
Request Foods Incorporated
- Product
- Kashi,Chimichurri Quinoa Bowl 9oz. UPC 18627 10440 Frozen…
- Reason
- The firm was notified by their supplier that ingredients used in their products were possibly contaminated with Listeria monocytogenes and Salmonella.
- Published
- November 14, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: May 20, 2020Historical recordClass II
Request Foods Incorporated
- Product
- Evol Butternut Squash Lasagna 10.8oz. UPC 91627 00794 Froz…
- Reason
- The firm was notified by their supplier that ingredients used in their products were possibly contaminated with Listeria monocytogenes and Salmonella.
- Published
- November 14, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: May 7, 2019Historical recordClass I
Sam Dry Fruits and Enterprises Inc.
- Product
- Inshell R/S 21/25 US- Select Pistachios; NET WT. 25 lb. (11…
- Reason
- Positive result for Salmonella received while investigating to determine supplier of direct customer's positive findings also for Salmonella
- Published
- November 14, 2018
- Distribution
- Multiple states
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: June 5, 2019Historical recordClass II
Trident Seafoods Corporation
- Product
- Kroger brand. Frozen non-ready to eat Alaskan Salmon Bites,…
- Reason
- Frozen non-ready to eat Alaskan Salmon Bites, Kroger brand, are recalled due to potential contamination with Listeria monocytogenes or Salmonella in vegetables ingredient.
- Published
- November 14, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: March 1, 2019Historical recordClass II
Aldi Inc
- Product
- Millville Maple & Brown Sugar Instant Oatmeal 15.1 oz. 10 i…
- Reason
- Complaints of insects in product
- Published
- November 14, 2018
- Distribution
- Aldi stores in: CT DE GA MA MD…
View recall →
Recall records are summarized from official FDA and USDA sources. Notices may be updated, reclassified, terminated, or withdrawn. Always review the linked official notice for the most current instructions.
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