Class II · Moderate risk Terminated
Taurine Injectable, 50mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
Reason Lack of Assurance of Sterility
FDA Drug Recalls
14,450 recalls · Class II, newest first
Class II · Moderate risk Terminated
Methylcobalamin Buffered Injectable, 1mg/mL, packaged in a) 10mL vial, b) 30mL Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Vitamin D3 Injectable, 10,000 U/mL, 10mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Co-Enzyme Q-10 Injectable, 20mg/mL, 10mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Procaine Injectables 20mg/mL and 2%, 50mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Riboflavin-5-Phosphate Injectable,10mg/mL, 10mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
MICML TRNDPPC Injection (Preserved) 10mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Ascorbic Acid Injectable 500mg/mL, packaged in a) 10mL vials, b) 50mL vials, c)100mL vials, Rx only, Downing Labs, LLC 4001…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Acetyl-L-Carnitine Injectable, 100mg/mL, 30mL vial, L-Carnitine Injection 500mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
EDTA Disodium Injectable, 150mg/mL, 100mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
L-Tryptophan Injectable, 30mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
L-Tyrosine Injectable, 25mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
L-Glutamine Injectable, 30mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Screenses Color Sunscreen, Tinted facial make-up compact, Broad Spectrum SPF 50 Light, 0.35 oz (10 g), Manufactured by Sesderma…
Reason cGMP Deviations; product does not comply with cGMP requirements
Class II · Moderate risk Ongoing
Screenses Color Sunscreen Tinted facial make-up compact, Broad Spectrum SPF 50, Brown, 0.35 oz (10 g), Manufactured by Sesderma…
Reason cGMP Deviations; product does not comply with cGMP requirements
Class II · Moderate risk Ongoing
Repaskin 30 (octacrylene 4%, oxybenzone 3%, octisalate 3%, octinoxate 3% Avobenzone 3%) Facial Sunscreen gel cream, Broad…
Reason cGMP Deviations; product does not comply with cGMP requirements
Class II · Moderate risk Ongoing
Repaskin 50 (octocrylene 7%, titanium oxide 2%) Facial Sunscreen gel cream, Broad Spectrum SPF 50, 1.7 fl oz (50 mL) tube, over…
Reason cGMP Deviations; product does not comply with cGMP requirements
Class II · Moderate risk Ongoing
Dryses Aluminum Chlorohydrate Deodorant for Women, Roll-on, 2.5 fl oz (75 mL) bottle, over the counter, Manufactured by Sesderma…
Reason cGMP Deviations; product does not comply with cGMP requirements
Class II · Moderate risk Ongoing
Dryses Aluminum Chlorohydrate Deodorant for Men Roll-on, 2.5 fl oz (75 mL) bottle, over the counter, Manufactured by Sesderma…
Reason cGMP Deviations; product does not comply with cGMP requirements
Class II · Moderate risk Ongoing
Repaskin 30 (octacrylene 4%, oxybenzone 3%, octisalate 3%, octinoxate 3% Avobenzone 3%) Body Lotion Sunscreen gel cream, Broad…
Reason cGMP Deviations; product does not comply with cGMP requirements
Class II · Moderate risk Ongoing
Repaskin 50 (octocrylene 7%, titanium dioxide 2%) Body Lotion Sunscreen gel cream, Broad Spectrum SPF 50, 6.8 fl oz (200 mL)…
Reason cGMP Deviations; product does not comply with cGMP requirements
Class II · Moderate risk Ongoing
Salises Facial Moisturizing Acne Treatment Gel, (salicylic acid 1.5%), 1.7 fl. oz (50 mL) bottle, over the counter, Manufactured…
Reason cGMP Deviations; product does not comply with cGMP requirements
Class II · Moderate risk Ongoing
Dryses Aluminum Chlorohydrate Antiperspirant Solution, 3.4 fl. oz (100 mL) bottle, over the counter, Manufactured by Sesderma…
Reason cGMP Deviations; product does not comply with cGMP requirements
Class II · Moderate risk Terminated
Sulfamethoxazole and Trimethoprim Tablets, USP, 800 mg/160 mg DOUBLE STRENGTH, 100-count bottle, Rx only, Mfg. by: Mutual…
Reason Presence of foreign substance -This recall has been intiated due to the presence of a polyethylene piece on the finished product.
Class II · Moderate risk Terminated
Testosterone USP 99.5%, .5% Stearic Acid NF Pellets, 3 mL, one-count vials, 25 mg (NDC 69761-125-01), 37.5 mg (NDC 69761-137-01)…
Reason Lack of Assurance of Sterility: The firm is recalling all sterile preparations within expiry due to deficient practices which may have an impact on…