🍔 Food 💊 Drugs 🏥 Medical Devices
Semaglutide/Cyanocobalamin 2mg/0.4mg/mL, 1mLvials, Tailor Made Compounding. Class II

Reason: Lack of Assurance of Sterility

TMC Acquisitions LLC dba Tailor Made Compounding 20230815 Terminated
Distributed: Nationwide within the USA
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All Over-The-Counter (OTC) drug products warehoused, salvaged, and sold by Inmar. Class II

Reason: CGMP Deviations: Potential exposure to rodents and rodent activity in the distribution center. Also, due to unusually hot weather, FDA Recalled Products may have been subjected to temperatures in excess of storage condition instructions on product labeling.

Inmar Supply Chain Solutions, LLC 20230814 Ongoing
Distributed: Separate Distribution List (salvage buyers) provided by Inmar and will be uploaded. Final customer distribution unknown.
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Bendamustine HCl Injection, 100mg/4mL (25mg/mL), One 4 mL Multiple-Dose Vial, Rx only, Manufactured for Baxter Healthcare Corporation, Deerfield, IL 60015, NDC 10019-079-01. Class III

Reason: Labeling: Missing Label; customer complaint received that labels were partially or completely peeled off injection vial.

Baxter Healthcare Corporation 20230814 Completed
Distributed: Nationwide in the U.S.A.
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Lugol's (Strong Iodine Solution USP), Each mL contains Iodine 0.05gm and potassium iodide 0.100gm, 8mL Single Use Vials, Rx Only, Manufactured for CooperSurgical, Trumbull, CT 06611, NDC 59365-6064-0, Ref 6064. Class II

Reason: CGMP Deviations: Products not manufactured under current good manufacturing practices.

Ecometics, Inc. 20230809 Completed
Distributed: Nationwide in the USA
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AstrinGyn (Ferric Subsulfate) Aqueous, 259 mg/g, 8 gm Single Use Vials, Manufactured for CooperSurgical, Trumbull, CT 06611, NDC 59365-6065-0, Ref 6065. Class II

Reason: CGMP Deviations: Products not manufactured under current good manufacturing practices.

Ecometics, Inc. 20230809 Completed
Distributed: Nationwide in the USA
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activator concentrate, Sodium Fluoride 0.96% in Activator Concentrate; 0.08% in diluted Activator Solution, Net 1 FL. OZ., Manufactured for: All USA Direct, LLC, Broadview, IL 60155. Class II

Reason: CGMP Deviations: Products not manufactured under current good manufacturing practices.

Ecometics, Inc. 20230809 Completed
Distributed: Nationwide in the USA
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Unguentine Ointment, (Camphor 3.0%, Phenol 2.5%, Tannic Acid 2.2%, Zinc Oxide 6.6%), labeled as a) NET WT 1 OZ (28 g) tubes, Improved Formula, UPC 0 11169 10216 0, and b) NET WT 1 OZ (28.3g) tubes, Maximum Strength, UPC 0 11169 11250 3, Distributed by: Oakhurst Company, Levittown, NY 11756. Class II

Reason: CGMP Deviations: Products not manufactured under current good manufacturing practices.

Ecometics, Inc. 20230809 Completed
Distributed: Nationwide in the USA
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ALCOLADO RELAMPAGO (Menthol and Camphor), 1% and 1.5% respectively, packaged in a 7 FLUID OZ (207 ml) bottles, UPC 7 18864 20102 9 and b) 16 FLUID OZ (472 ml) bottles, UPC 7 18864, 20110 4, Distributed by: The Larkspur Group, Inc., Norwalk, CT 06854. Class II

Reason: CGMP Deviations: Products not manufactured under current good manufacturing practices.

Ecometics, Inc. 20230809 Completed
Distributed: Nationwide in the USA
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YAGER'S LINIMENT (Camphor and Turpentine Oil) 3.1% and 8.12% respectively, packaged in a) 4 FL OZ (118 mL) bottles, UPC 0 11169 00004 6, and 8 FL OZ (236 mL) bottles, UPC 0 11169 00008 4, The Oakhurst Co., Dist., Levittown, NY 11756. Class II

Reason: CGMP Deviations: Products not manufactured under current good manufacturing practices.

Ecometics, Inc. 20230809 Completed
Distributed: Nationwide in the USA
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Blis-To-Sol Liquid (Tolnaftate), 1%, packaged in a) 1 FLUID OZ. (29.5 mL) bottles, UPC 0 11169 20011 8 and b) 1.85 FLUID OZ. (54.5 mL) bottles, UPC 0 11169 20012 5, Distributed by Oakhurst Company, Levittown, NY 11756. Class II

Reason: CGMP Deviations: Products not manufactured under current good manufacturing practices.

Ecometics, Inc. 20230809 Completed
Distributed: Nationwide in the USA
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