🍔 Food 💊 Drugs 🏥 Medical Devices
Biotin 5mg/mL, 5mL-vial, Refrigerate, Tailor Made Compounding Class II

Reason: Lack of Assurance of Sterility

TMC Acquisition LLC dba Tailor Made Compounding 20220307 Ongoing
Distributed: Nationwide USA and Puerto Rico
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BCAAs (Leucine/Iso-Leucine/Valine) 10mg/10mg/5mg/mL, 30mL-vial, Refrigerate, Tailor Made Compounding Class II

Reason: Lack of Assurance of Sterility

TMC Acquisition LLC dba Tailor Made Compounding 20220307 Ongoing
Distributed: Nationwide USA and Puerto Rico
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Ascorbic Acid 500mg/mL, a) 25 ml-vial, b) 50 ml-vial, Refrigerate, Tailor Made Compounding Class II

Reason: Lack of Assurance of Sterility

TMC Acquisition LLC dba Tailor Made Compounding 20220307 Ongoing
Distributed: Nationwide USA and Puerto Rico
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Anastrozole/Testosterone Cypionate/Propionate 1mg/160mg/40mg/mL, 10 mL-vial, Room Temperature, Tailor Made Compounding Class II

Reason: Lack of Assurance of Sterility

TMC Acquisition LLC dba Tailor Made Compounding 20220307 Ongoing
Distributed: Nationwide USA and Puerto Rico
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Alprostadil/Papaverine/Phentolamine 60mcg/30mg/3mg/mL, 3mL-vial, Refrigerate, Tailor Made Compounding Class II

Reason: Lack of Assurance of Sterility

TMC Acquisition LLC dba Tailor Made Compounding 20220307 Ongoing
Distributed: Nationwide USA and Puerto Rico
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Alpha Lipoic Acid 25mg/mL, 30mL-vial, Refrigerate, Tailor Made Compounding Class II

Reason: Lack of Assurance of Sterility

TMC Acquisition LLC dba Tailor Made Compounding 20220307 Ongoing
Distributed: Nationwide USA and Puerto Rico
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Hydrogen Peroxide Topical Solution, USP, 32 fl. oz. (1 QT) 946 mL, Distributed by: CVS Pharmacy, Inc. One CVS Drive Woonsocket, RI 02895, NDC 59779-871-45, UPC 0-50428-40950-3 Class II

Reason: Labeling: Label Mix-Up-The primary label on the front of the bottles have Hydrogen Peroxide affixed to the front and back of the containers. However, the product inside the bottle is 70% Isopropyl Alcohol.

Vi-Jon, LLC 20220624 Terminated
Distributed: USA Nationwide
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Testosterone Cypionate Injection, USP, 200mg/mL, CIII, Rx only, 1mL Single-dose vial, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceuticals Industries Ltd., Halol- Baroda Highway, Halol-Baroda, Highway, Halol- 389 350, Gujarat, India, NDC 62756-015-40. Class II

Reason: cGMP - Water leakage

SUN PHARMACEUTICAL INDUSTRIES INC 20220621 Terminated
Distributed: USA Nationwide
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Draximage MAA (Kit for the preparation of Technnetium Tc 99m Albumin Aggregate) 2.5 mg per vial, 30 glass vials per carton, Rx Only, Manufactured for Jubilant Draximage Inc. Kirkland, Canada, NDC 65174-270-30. Class II

Reason: Lack of Assurance of Sterility: Out-of-specification test results obtained for Endotoxin testing.

Jubilant Draximage Inc 20220616 Terminated
Distributed: Product was distributed to retailers nationwide.
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Morphine Sulfate extended-Release Tablets, USP; 60 mg, 100-count bottles, Rx only, manufactured by: Ohm Laboratories Inc., NJ; Relabeled by: Bryant Ranch Prepack, Inc, CA, NDC 63629-1089-01 Class I

Reason: Labeling: Label Mix-up: bottles labeled as Morphine Sulfate 60 mg Extended-Release tablets contain Morphine Sulfate 30 mg Extended-Release tablets and bottles labeled as Morphine Sulfate 30 mg Extended-Release tablets may contain Morphine Sulfate 60 mg Extended-Release tablets.

Bryant Ranch Prepack, Inc. 20220617 Terminated
Distributed: Distributed to one wholesaler in AL for further distribution in the US.
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