Taizhou Kangping Medical Science And Technology Co., Ltd.
Class IIOngoing
BZK Antiseptic Towelette, Sterile, For External Use Only, benzalkonium chloride 0.13%, Antiseptic, 100 towelettes per carton , For Professional use, Mfg by: Taizhou Kangping Medical, Taizhou, JiangSu,...
Reason: Lack of Assurance of Sterility.
D-0589-2025August 27, 2025Taizhou, N/A
PFIZER INC
Class IIOngoing
Vial Label: Epinephrine Injection, USP, 1mg/10mL (0.1 mg/mL), Rx only, Distributed by Hospira, Inc., Lake Forest, IL 60045, USA. NDC 0409-4933-05. Case: NDC 0409-4933-10.
Reason: Lack of Assurance of Sterility.
D-0590-2025August 27, 2025New York, NY
PFIZER INC
Class IIOngoing
Vial Label: 8.4% Sodium Bicarbonate Injection, USP, 50mEq/50 mL (1 mEq/mL), Rx only, Hospira, Inc., Lake Forest, IL 60045, USA, NDC 0409-6637-24. Case NDC: 00409-6637-14.
Reason: Lack of Assurance of Sterility.
D-0591-2025August 27, 2025New York, NY
B BRAUN MEDICAL INC
Class IIOngoing
0.9% Sodium Chloride Injection USP, L 8000, 1000mL Excel Container, Rx Only, Sterile, nonpyrogenic, single dose container, B. Braun Medical Inc., Bethlehem, PA 18018, NDC 0264-7800-00.
Reason: Lack of Assurance of Sterility; potential for fluid leakage at one of the weld sites.
D-0586-2025August 20, 2025Allentown, PA
B BRAUN MEDICAL INC
Class IIOngoing
Lactated Ringer's Injection USP, L 7500, 1000mL Excel Container, Rx Only, Sterile, nonpyrogenic, single dose container, B. Braun Medical Inc., Bethlehem, PA 18018, NDC 0264-7750-00.
Reason: Lack of Assurance of Sterility; potential for fluid leakage at one of the weld sites.
D-0585-2025August 20, 2025Allentown, PA
Cipla USA, Inc.
Class IIOngoing
Budesonide Inhalation Suspension, 0.5mg/2ml, 30 single-dose ampules per carton, five per pouch, RX Only, Manufactured by: Cipla Ltd. Indore SEZ, Pithampur, India. Manufactured for: Ciple USA, Inc. 10 ...
Reason: Lack of Assurance of Sterility: A market complaint was received for leakage and empty ampoule.
D-0541-2025July 30, 2025Warren, NJ
Tailstorm Health INC
Class IIOngoing
LIDOcaine HCl Injection, USP, 10mg/mL, 1% (100 mg/10mL), 10 mL Sterile Single Dose Vial, Rx Only, For Infiltration & Nerve Block, Including Caudal & Epidural Use, Preservative-Free, For Office Use Onl...
Reason: Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
Reason: Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
D-0503-2025July 9, 2025Phoenix, AZ
Tailstorm Health INC
Class IIOngoing
KETAmine Hydrochloride Injection, USP, 50 mg/5mL (10 mg/mL), For IM Use or Slow IV Use, 5 mL Sterile Single-Dose Vial, Rx Only, For Office Use Only, Compounded Durg by: Medivant Healthcare, 158 S. Kyr...
Reason: Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
D-0500-2025July 9, 2025Phoenix, AZ
Tailstorm Health INC
Class IIOngoing
LIDOcaine HCL Sterile Injection, USP, 100mg/10mL, 1%, (10mg/mL), w/EPINEPHRINE 1:100,000, For Infiltration & Nerve Block, Including Caudal & Epidural Use, 10 mL Sterile Single-Dose Vial, For Office Us...
Reason: Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
D-0502-2025July 9, 2025Phoenix, AZ
Tailstorm Health INC
Class IIOngoing
KETAmine Hydrochloride Injection, USP, 500mg/5mL, (10mg/mL), For IM or Slow IV Use, 5mL Sterile Multi-Dose Vial, Rx Only, For Office Use Only, Compounded Drug by: Medivant Healthcare, 158 S. Kyrene, R...
Reason: Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
D-0501-2025July 9, 2025Phoenix, AZ
Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado)
Class IIOngoing
Nicotinamide adenine dinucleotide (NAD+): 100mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112
Reason: Lack of Assurance of Sterility
D-0478-2025July 2, 2025Englewood, CO
Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado)
Class IIOngoing
Semaglutide, 5 mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112
Reason: Lack of Assurance of Sterility
D-0480-2025July 2, 2025Englewood, CO
Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado)
Class IIOngoing
Methylcobalamin Injectable, 10mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112
Reason: Lack of Assurance of Sterility
D-0474-2025July 2, 2025Englewood, CO
Fresenius Medical Care Holdings, Inc.
Class IIOngoing
0.9% Sodium Chloride Injection, USP, Flexible Plastic Container, Rx Only Fresenius Medical Care North America, Waltham, MA 02451, 1-800-323-5188, NDC 49230-300-10
Reason: Lack of Assurance of Sterility
D-0490-2025July 2, 2025Waltham, MA
Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado)
Class IIOngoing
LL Bioboost Injectable, Each 1mL contains Methionine 25 mg, Inositol 50 mg, Choline Chloride 50 mg, and Cyanocobalamin 1 mg in SWFI, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, S...
Reason: Lack of Assurance of Sterility
D-0476-2025July 2, 2025Englewood, CO
Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado)
Class IIOngoing
Nicotinamide adenine dinucleotide (NAD+): 100mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112