Class II · Moderate risk Ongoing
GHK-Cu (Copper Peptide) for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL…
Reason Lack of Assurance of Sterility
Is Copper recalled?
28 FDA recalls mention Copper. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Copper.
Class II · Moderate risk Terminated
Kit for the Preparation of Technetium Tc 99m Sestamibi Injection, Each Kit contains: 30 sterile and non-pyrogenic reaction vials…
Reason Lack of Assurance of Sterility; Improper crimps on vials impacting the integrity of the product
Class II · Moderate risk Ongoing
BANANA BOAT SPRT CLR SPRY SPF50 6 FL OZ SKU 2007524 SUNTONE SPORT SPRAY SPF 50 5.5 OZ SKU 2096102 HAWAIIAN TROPIC TANNING OIL…
Reason CGMP Deviations: product held outside appropriate storage temperature conditions.
Class II · Moderate risk Completed
Olympia Mineral Blend Magnesium Chloride 80 mg/mL Zinc Sulfate 1 mg/mL Manganese Sulfate 20 mcg/mL Copper Gluconate 0.2 mg/mL…
Reason Lack of assurance of sterility.
Class I · High risk Terminated
PARAGARD T380A (intrauterine copper contraceptive), 1 unit per carton together with an insertion tube and solid white rod in a…
Reason Non-sterility
Class II · Moderate risk Terminated
Coppertone Pure & Simple baby 50 Sunscreen Spray (To Deliver) Zinc Oxide 24.08%, NET WT 5 OZ (142 g) can, Beiersdorf Inc…
Reason cGMP Deviations
Class II · Moderate risk Terminated
Coppertone Pure & Simple kids 50 Sunscreen Spray (To Deliver) Zinc Oxide 24.08%, NET WT 5 OZ (142 g) can, Beiersdorf Inc…
Reason cGMP Deviations
Class II · Moderate risk Terminated
Coppertone Pure & Simple 50 Sunscreen Spray (To Deliver) Zinc Oxide 24.08%, NET WT 5 OZ (142 g) can, Beiersdorf Inc., Wilton, CT…
Reason cGMP Deviations
Class I · High risk Terminated
Coppertone SPORT Sunscreen Spray 50, (To Deliver) Avobenzone 3%, Homosalate 10%, Octisalate 5%, Octocrylene 5%, NET WT 1.6 OZ (45…
Reason Chemical contamination; presence of benzene
Class I · High risk Terminated
Coppertone SPORT MINERAL 50 Sunscreen Spray (To Deliver) Zinc Oxide 24.08%, NET WT 5 OZ (142 g) can, Beiersdorf Inc., Wilton, CT…
Reason Chemical contamination; presence of benzene
Class I · High risk Terminated
Coppertone Pure & Simple baby 50 Sunscreen Spray (To Deliver) Zinc Oxide 24.08%, NET WT 5 OZ (142 g) can, Beiersdorf Inc…
Reason Chemical contamination; presence of benzene
Class I · High risk Terminated
Coppertone Pure & Simple kids 50 Sunscreen Spray (To Deliver) Zinc Oxide 24.08%, NET WT 5 OZ (142 g) can, Beiersdorf Inc…
Reason Chemical contamination; presence of benzene
Class I · High risk Terminated
Coppertone Pure & Simple 50 Sunscreen Spray (To Deliver) Zinc Oxide 24.08%, NET WT 5 OZ (142 g) can, Beiersdorf Inc., Wilton, CT…
Reason Chemical contamination; presence of benzene
Class II · Moderate risk Terminated
Copper 0.4MG/ML (PVF) INJECTION SOLUTION, 10 ML per vial, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Multi Trace, Zinc/Copper/Manganese/Selenium 5mg/1mg/0.5mg/60mcg/ml, injection 30 mL, Rx Only, Compounded Prescription, Promise…
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Coppertone Kids Sunscreen Spray (avobenzone 3%, Homosalate 10%, Octisalate 5%, Octocrylene 4%, Oxybenzone 5%) 8.3 oz. bottle…
Reason Labeling: Label mix-up
Class II · Moderate risk Terminated
Coppertone SUNSCREEN LOTION, CLEARLY SHEER, BROAD SPECTRUM SPF 50, 5 FL OZ (147mL), OTC, Dist by: Bayer HealthCare LLC, Whippany…
Reason Labeling; Product Contains Undeclared API (Oxybenzone)
Class II · Moderate risk Terminated
Copper (Cupric)Sulfate 2 mg/ml Injectable, Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville…
Reason Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Class II · Moderate risk Terminated
TPN 2:1, 200 ml Bags, Qty: 7, Base Formula NaCl 0.9%, Dextrose 70%, Trophamine 10%, Water for Inj; Electrolytes Calcium Gluc…
Reason Lack of Assurance of Sterility: Sterility of product is not assured.
Class II · Moderate risk Terminated
TPN 3:1, 997 ml without lipids Bags, Qty: 3, Base Formula Dextrose 70%, Travasol 10%, Water for Inj; Electrolytes K Acetate, Na…
Reason Lack of Assurance of Sterility: Sterility of product is not assured.
Class II · Moderate risk Terminated
TPN 3:1, 997 ml with lipids Bags, Qty: 7, Base Formula Dextrose 70%, Travasol 10%, Intralipid 20%, Water for Inj; Electrolytes K…
Reason Lack of Assurance of Sterility: Sterility of product is not assured.
Class II · Moderate risk Terminated
COPPER (SULF), 0.4 mg/mL, injectable, 20 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070
Reason Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality…
Class II · Moderate risk Terminated
ParaGard T 380A - Intrauterine Copper Contraceptive, 176 mg of copper wire, Duramed Pharmaceuticals Inc, a subsidiary of Barr…
Reason Non-sterility: due to a failed sterility test
Class II · Moderate risk Terminated
COPPER 0.4MG/ML INJECTABLE, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical…
Reason Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility…
Class II · Moderate risk Terminated
CHLOROPHYLLIN COPPER COMPLEX, Tablet, 100 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 11868000901
Reason Labeling: Label Mixup; CHLOROPHYLLIN COPPER COMPLEX, Tablet, 100 mg may be potentially mislabeled as traZODone HCl, Tablet, 50 mg, NDC…
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