🍔 Food 💊 Drugs 🏥 Medical Devices
Old Spice, PURE SPORT, (Aluminum Chlorohydrate 23.5%), Anti-Perspirant & Deodorant Spray, Topical spray can, Net WT 6.0 OZ (170g), Distributed by Procter & Gamble, Cincinnati, OH 45202. NDC: 37000-199-60, UPC 0 12044 00191 2 Class I

Reason: Chemical contamination: presence of benzene

The Procter & Gamble Company 20211123 Terminated
Distributed: Nationwide USA and Puerto Rico, Canada, Guam, Northern Mariana Islands, American Samoa, Bhutan, Timor-Leste, Maldives, Fiji, US Virgin Islands, Trinidad, Peru, Saint Marteen, Bahamas, Costa Rica, Guatemala, Honduras, Panama, Belize, Santa Lucia, Aruba, Dominican Republic, Guyana
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Ibuprofen and Famotidine Tablets 800mg/26.6mg, Rx Only, 90 Tablets per Bottle, manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend Laboratories, LLC., Parsippany, NJ 07054, NDC 67877-626-90 Class II

Reason: Presence of Foreign Tablet/Capsule: A stray Rasagiline Mesylate 1 mg tablet was discovered in an unopened bottle of Ibuprofen and Famotidine.

Ascend Laboratories, LLC 20231229 Ongoing
Distributed: Nationwide
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Americaine, (benzocaine 20%) Benzocaine Topical Anesthetic Spray, Aerosol Can 2 oz (57 G), Dist. by Insight Pharmaceuticals Corp. Tarrytown, NY 10591, USA, A Prestige Consumer Healthcare company. Made in India. NDC 63736-378-02, Can UPC 3 63736 37882 0; Case UPC 1 03 63736 37882 7 Class I

Reason: Chemical Contamination: presence of benzene

Insight Pharmaceuticals LLC, a Prestige Consumer Healthcare company 20231221 Completed
Distributed: Nationwide in the USA
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Atropine Sulfate Injection, USP 1 mg/10 mL (0.1 mg/mL), Lifeshield, Glass ABBOJECT Unit of Use Syringe, Rx Only, 10 mL Syringe per Carton, Hospira, Inc., Lake FOrest, IL 60045, NDC 0409-4911-11 (carton), 0409-4911-34 (case). Class I

Reason: Presence of Particulate Matter; identified as glass

Pfizer Inc. 20231221 Ongoing
Distributed: Nationwide in the USA and Puerto Rico.
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8.4 % Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL), Lifeshield, Glass ABBOJECT Unit of Use Syringe, Rx Only, 50 mL Syringe per Carton, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-6637-24 (carton), 0409-6637-14 (case). Class I

Reason: Presence of Particulate Matter; identified as glass

Pfizer Inc. 20231221 Ongoing
Distributed: Nationwide in the USA and Puerto Rico.
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4.2% Sodium Bicarbonate Injection, USP 5 mEq/10 mL (0.5 mEq/mL), Glass ABBOJECT Unit of Use Syringe, For Intravenous Use, Rx Only, 10 mL Syringe per Carton, Hospira, Inc., Lake Forst, IL 60045, NDC 0409-5534-24 (carton), 0409-5534-14 (case). Class I

Reason: Presence of Particulate Matter; identified as glass

Pfizer Inc. 20231221 Ongoing
Distributed: Nationwide in the USA and Puerto Rico.
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Vasostrict (vasopressin in 5% Dextrose) Injection, 20 units per 100 mL (0.2 units per mL), 100 mL x 10 Single Dose Vials per carton, Ready to Use, For Intravenous Infusion, Rx Only, Distributed by: Par Pharmaceutical, Chestnut Ridge, NY 10977. NDC: 42023-237-10 Class II

Reason: Superpotent Drug: Assay from the 3-month and 6-month stability intervals exceeded the upper specification limit.

Par Sterile Products LLC 20240111 Ongoing
Distributed: Nationwide USA
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Freskaro refresh & revitalize Magnesium Citrate Saline Laxative Oral Solution Cherry Flavor 10 fl. oz, Manufactured by: Pharma Lobis, 7400 Alumax Dr., Texarkana, TX 75501, NDC 82645-312-10. Class II

Reason: MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS - Presence of Acetobacter nitrogenifigens bacteria.

Pharma Nobis LLC 20231221 Ongoing
Distributed: Nationwide.
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Freskaro refresh & revitalize Magnesium Citrate Saline Laxative Oral Solution Grape Flavor 10 fl. oz, Manufactured by: Pharma Lobis, 7400 Alumax Dr., Texarkana, TX 75501, NDC 82645-311-10. Class II

Reason: MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS - Presence of Acetobacter nitrogenifigens bacteria.

Pharma Nobis LLC 20231221 Ongoing
Distributed: Nationwide.
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CVS Health Magnesium Citrate Saline Laxative Oral Solution DYE FREE Grape Flavor 10 fl. oz, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, NDC 51316-881-10. Class II

Reason: MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS - Presence of Acetobacter nitrogenifigens bacteria.

Pharma Nobis LLC 20231221 Ongoing
Distributed: Nationwide.
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