Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado)
Class IIOngoing
Tirzepatide/Cyanocobalamin Injectable, 30mg/1mg/mL (15mg/0.5mg/0.5mL), pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112
Reason: Lack of Assurance of Sterility
D-0486-2025July 2, 2025Englewood, CO
B BRAUN MEDICAL INC
Class IIOngoing
0.9% Sodium Chloride Injection USP, 500 mL, packaged in 500 mL excel containers and further packaged 24 per case, Rx only, B.Braun Medical Inc., Bethlehem, PA 18018-3524, USA, NDC 0264-7800-10.
Reason: Lack of assurance of sterility: pinholes, within the finger boxes used during Form Fill Seal process resulting in leaks.
D-0491-2025July 2, 2025Allentown, PA
Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado)
Reason: cGMP deviations and lack of assurance of sterility.
D-0404-2025May 14, 2025Saint Louis, MO
American Regent, Inc.
Class IIOngoing
niCARdipine Hydrochloride Injection, USP, 25 mg/10 mL (2.5 mg/mL), 10 mL Single Dose Vial, Rx Only, Mfd for: Civica, Inc., Lehi, UT 84043,Mfd by: American Regent, Inc., New Albany, OH 43064. NDC Carto...
Reason: Lack of sterility assurance: Product leakage around the vial neck, which could potentially result in a lack of sterility assurance.
D-0398-2025May 7, 2025New Albany, OH
American Regent, Inc.
Class IIOngoing
niCARdipine Hydrochloride Injection, USP, 25 mg/10 mL (2.5 mg/mL), 10 mL Single Dose Vial, Rx Only, American Regent, Inc., Shirley, NY 11967. NDC carton: 0517-0735-10 / NDC Vial: 0517-0735-01]
Reason: Lack of sterility assurance: Product leakage around the vial neck, which could potentially result in a lack of sterility assurance.
D-0399-2025May 7, 2025New Albany, OH
Amerisource Health Services LLC
Class IIOngoing
Haloperidol Decanoate Injection, 100 mg/mL*, 1 x 1 mL Single-Dose Vial, Rx only, Manufactured by: Somerset Therapeutics Limited, #54/1, Boodhihal Village, Nelamangala, Bangalore - 562123, Karnataka, ...
Reason: Lack of assurance of sterility. Bacterial contamination detected in some media fill units
D-0368-2025April 30, 2025Columbus, OH
Denver Solutions, LLC DBA Leiters Health
Class IIOngoing
Rocuronium Bromide 50 mg per 5mL (10mg per mL), 5mL Single Dose Syringe, Rx only, Leiters Health, 13796 Compark Blvd, Englewood, CO 80112. NDC: 71449-004-11
Reason: Lack of Assurance of Sterility: Leaking/damaged syringes.
D-0374-2025April 30, 2025Englewood, CO
Denver Solutions, LLC DBA Leiters Health
Class IIOngoing
Ketamine HCl 50mg per 5mL (10 mg per mL), 5mL Single Dose Syringe, Rx only, Leiters Health, 13796 Compark Blvd, Englewood, CO 80112.NDC: 71449-068-11
Reason: Lack of Assurance of Sterility: Leaking/damaged syringes.
D-0373-2025April 30, 2025Englewood, CO
Amerisource Health Services LLC
Class IIOngoing
Haloperidol Decanoate Injection, 100mg/mL*, 5 x 1 mL Single-Dose Vials, Rx Only, Manufactured by: Somerset Therapeutics Limited, #54/1 Boodhihal Village, Nelamangala, Bangalore -562123, Karnataka, In...
Reason: Lack of assurance of sterility. Bacterial contamination detected in some media fill units
D-0369-2025April 30, 2025Columbus, OH
Denver Solutions, LLC DBA Leiters Health
Class IIOngoing
PHENYLephrine HCl in 0.9% Sodium Chloride, 0.5 mg per 5mL (100 mcg/mL), 5 mL Single Dose Syringe, Rx Only, Leiters Health, 13796 Compark Blvd, Englewood, CO 80112. NDC: 71449-001-11,
Reason: Lack of Assurance of Sterility: Leaking/damaged syringes.
D-0372-2025April 30, 2025Englewood, CO
Denver Solutions, LLC DBA Leiters Health
Class IIOngoing
dexmedeTOMIDine HCl PF, in 0.9% Sodium Chloride, 20 mcg (base) per 5mL, (4 mcg (base) per mL), 5mL Single Dose syringe, Rx only, Leiters Health, 13796 Compark Blvd, Englewood, CO 80112, NDC: 71449-131...
Reason: Lack of Assurance of Sterility: Leaking/damaged syringes.
D-0371-2025April 30, 2025Englewood, CO
Denver Solutions, LLC DBA Leiters Health
Class IIOngoing
Glycopyrrolate, 1mg per 5mL, (0.2 mg/mL), Single Dose 5 mL syringe, Rx only, Leiters Health, 13796 Compark Blvd, Englewood, CO 80112. NDC 71449-104-11
Reason: Lack of Assurance of Sterility: Leaking/damaged syringes.
D-0370-2025April 30, 2025Englewood, CO
Amerisource Health Services LLC
Class IIOngoing
Haloperidol Decanoate Injection, 50mg/mL* , 1 mL Single-Dose Vial, Rx only, Manufactured by Somerset Therapeutics Limited, 54/1, Boodhihal Village, Nelamangala, Bangalore - 562123, Karnataka, India, M...
Reason: Lack of assurance of sterility. Bacterial contamination detected in some media fill units