Estados Unidos Recalls
Retiros de seguridad del consumidor de la FDA, CPSC, NHTSA y USDA FSIS.
FDA DrugsBEEKEEPER'S NATURALS Saline Nasal Spray, Sinus Congestion Rinse, Made with Propolis + Xylitol, 1 FL OZ (30 mL) per bottle, Manufactured For: Beekeeper's Naturals USA Inc., Covina, CA 91789.
BEEKEEPER'S NATURALS Saline Nasal Spray, Sinus Congestion Rinse, Made with Propolis + Xylitol, 1 FL OZ (30 mL) per bottle, Manufactured For: Beekeeper's Naturals USA Inc., Covina, CA 91789.
Microbial Contamination of Non-Sterile Products
FDA DevicesProduct Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 24 Fr PUSH OTW Model/Catalog Number: 7170-24 Product Description: Feeding Tube Kit Component: No
Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 24 Fr PUSH OTW Model/Catalog Number: 7170-24 Product Description: Feeding Tube Kit Component: No
Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
FDA DrugsMinocycline Hydrochloride Extended-Release Tablets, USP, 115 mg, 30-count bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA. Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054. NDC: 67877-644-30
Minocycline Hydrochloride Extended-Release Tablets, USP, 115 mg, 30-count bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA. Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054. NDC: 67877-644-30
Failed Dissolution Specifications: An out-of-specification (OOS) result was observed during the 9th month of dissolution test analysis
FDA DevicesProduct Name: CORFLO* Safety PEG Kit with ENFit¿ Connector Model/Catalog Number: 50-4320
Product Name: CORFLO* Safety PEG Kit with ENFit¿ Connector Model/Catalog Number: 50-4320
Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
FDA DrugsBudesonide Inhalation Suspension, 1mg/2mL, 30 x 2 mL Sterile Single-Dose Ampules (5 Single-Dose Ampules per pouch, 6 pouches per carton, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limited, Baska Ujeti Road, Ujeti Halol-289350, Gujarat, India, NDC 47335-633-49.
Budesonide Inhalation Suspension, 1mg/2mL, 30 x 2 mL Sterile Single-Dose Ampules (5 Single-Dose Ampules per pouch, 6 pouches per carton, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limited, Baska Ujeti Road, Ujeti Halol-289350, Gujarat, India, NDC 47335-633-49.
Presence of Foreign Substance:This recall has been initiated in response to a product quality complaint reported for black/brown specs and particles within the ampoule solution
FDA FoodWeiKFiELD Custard Powder Kesar Pista, Net Wt. 300g (10.6 OZ.), Poly Jar , 24 units per outer case.
WeiKFiELD Custard Powder Kesar Pista, Net Wt. 300g (10.6 OZ.), Poly Jar , 24 units per outer case.
The ingredient, Pista, currently declared on our label should be corrected to the standard American nomenclature, Pistachio.
FDA FoodFarm Rich Pizza Cheese Crunchers
Farm Rich Pizza Cheese Crunchers
May contain metal pieces
FDA FoodJumbo Brazo Gitano Caramelo [image] Jumbo Caramel Roll The Original, Net Wt. 40 oz, packaged in a rigid plastic clamshell container with a transparent dome lid, one unit per container. KEEP REFRIGERATED. UPC 824790852645
Jumbo Brazo Gitano Caramelo [image] Jumbo Caramel Roll The Original, Net Wt. 40 oz, packaged in a rigid plastic clamshell container with a transparent dome lid, one unit per container. KEEP REFRIGERATED. UPC 824790852645
Undeclared colors (Yellow #5, Yellow #6, and/or Red #40).
FDA FoodMarquesita de Guava [image] Delighted Flavored Cakes The Original, Net Wt. 16 oz, packaged in a transparent and rigid plastic clamshell container, one unit per container. KEEP REFRIGERATED. UPC 824790852706
Marquesita de Guava [image] Delighted Flavored Cakes The Original, Net Wt. 16 oz, packaged in a transparent and rigid plastic clamshell container, one unit per container. KEEP REFRIGERATED. UPC 824790852706
Undeclared colors (Yellow #5, Yellow #6, and/or Red #40).
FDA DevicesBoston Scientific Model SC-4318, Clik X Anchor REF: M365SC43180
Boston Scientific Model SC-4318, Clik X Anchor REF: M365SC43180
Sterile anchors my lack sterility assurance.
FDA FoodCake de Capuchino [image] Capuchino Cake The Original, Net Wt. 63 oz, packaged in a transparent and rigid plastic clamshell container with a transparent dome lid and tray base, one unit per container. KEEP REFRIGERATED. UPC 824790850375
Cake de Capuchino [image] Capuchino Cake The Original, Net Wt. 63 oz, packaged in a transparent and rigid plastic clamshell container with a transparent dome lid and tray base, one unit per container. KEEP REFRIGERATED. UPC 824790850375
Undeclared colors (Yellow #5, Yellow #6, and/or Red #40).
FDA FoodMarquesita de Fresa [image] Delighted Flavored Cakes The Original, Net Wt. 16 oz, packaged in a transparent and rigid plastic clamshell container, one unit per container. KEEP REFRIGERATED. UPC 824790852706
Marquesita de Fresa [image] Delighted Flavored Cakes The Original, Net Wt. 16 oz, packaged in a transparent and rigid plastic clamshell container, one unit per container. KEEP REFRIGERATED. UPC 824790852706
Undeclared colors (Yellow #5, Yellow #6, and/or Red #40).
FDA DrugsGas-X Extra Strength, SIMETHICONE 125 mg/ANTIGAS, packaged in a) 120 SoftGels (UPC 3 00674 35041 9, b) 72 SoftGels (UPC 3 00439 00572 1), Distributed by: Haleon, Warren, NJ 07059.
Gas-X Extra Strength, SIMETHICONE 125 mg/ANTIGAS, packaged in a) 120 SoftGels (UPC 3 00674 35041 9, b) 72 SoftGels (UPC 3 00439 00572 1), Distributed by: Haleon, Warren, NJ 07059.
Chemical Contamination: contamination with a diluted propylene glycol-based coolant from a machine leakage during the packaging process.
FDA FoodMarquesita de Dulceleche [image] Delighted Flavored Cakes The Original, Net Wt. 16 oz, packaged in a transparent and rigid plastic clamshell container, one unit per container. KEEP REFRIGERATED. UPC 824790852706
Marquesita de Dulceleche [image] Delighted Flavored Cakes The Original, Net Wt. 16 oz, packaged in a transparent and rigid plastic clamshell container, one unit per container. KEEP REFRIGERATED. UPC 824790852706
Undeclared colors (Yellow #5, Yellow #6, and/or Red #40).
FDA DevicesProduct Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 14 Fr PUSH OTW Model/Catalog Number: 7170-14 Product Description: Feeding Tube Kit
Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 14 Fr PUSH OTW Model/Catalog Number: 7170-14 Product Description: Feeding Tube Kit
Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
FDA DevicesAllia IGS 3 Pulse angiographic X-ray system
Allia IGS 3 Pulse angiographic X-ray system
GE HealthCare has become aware of a potential issue affecting an electrical cable on certain IGS systems equipped with Gaia generators. This issue could lead to a risk of electrical shock to service personnel performing installation, maintenance, or troubleshooting activities inside the C-FRT cabinet while power is ON.
FDA DevicesAdvance Aluminum Chloride Gel Clear Hemostatic Gel Kit, Catalog number 504600-28
Advance Aluminum Chloride Gel Clear Hemostatic Gel Kit, Catalog number 504600-28
Some units of Aluminum Chloride Gel contain the package insert for Ferric Sulfate Gel. The incorrect insert misidentifies the product and contains different first aid instructions, most critically in that the Ferric Sulfate insert instructs users to induce vomiting in the case of ingestion, while the correct Aluminum Chloride insert instructs users not to induce vomiting.
FDA DevicesProduct Name: CORFLO* Safety PEG Kit with ENFit¿ Connector Model/Catalog Number: 50-6312
Product Name: CORFLO* Safety PEG Kit with ENFit¿ Connector Model/Catalog Number: 50-6312
Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
FDA FoodCake de Fresa y Chocolate [image] Stawberry & Chocolate Cake The Original, Net Wt. 48 oz, packaged in a rigid plastic clamshell container with a transparent dome lid and tray base, one unit per container. KEEP REFRIGERATED. UPC 824790852980
Cake de Fresa y Chocolate [image] Stawberry & Chocolate Cake The Original, Net Wt. 48 oz, packaged in a rigid plastic clamshell container with a transparent dome lid and tray base, one unit per container. KEEP REFRIGERATED. UPC 824790852980
Undeclared colors (Yellow #5, Yellow #6, and/or Red #40).
FDA DevicesProduct Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 24 Fr PULL Model/Catalog Number: 7180-24
Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 24 Fr PULL Model/Catalog Number: 7180-24
Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
FDA DevicesProduct Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 14 Fr PULL Model/Catalog Number: 7180-14
Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 14 Fr PULL Model/Catalog Number: 7180-14
Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
FDA DevicesBicarby Dialysate; Model number: RFP-400-G;
Bicarby Dialysate; Model number: RFP-400-G;
There is an error in the labeling of the GTIN on the product. When scanned; however, the case labeling, lot number, and printed labeling on the product correctly identifies the product code and the solution contained in the bag. In the event the incorrect GTIN labeling is used as the singular source for product identification, unrecognized use of a potassium solution with a concentration differing from the prescription may result.
FDA FoodNapolitano [image] Neapolitan The Original, Net Wt. 22 oz, packaged in a transparent and rigid plastic clamshell container, one unit per container. KEEP REFRIGERATED. UPC 824790852256
Napolitano [image] Neapolitan The Original, Net Wt. 22 oz, packaged in a transparent and rigid plastic clamshell container, one unit per container. KEEP REFRIGERATED. UPC 824790852256
Undeclared colors (Yellow #5, Yellow #6, and/or Red #40).
FDA DevicesPlum Solo Precision IV Pump, 40001-0401
Plum Solo Precision IV Pump, 40001-0401
Under certain conditions, the pump may not display a soft limit alert, and will not notify the clinician of a soft limit violation before confirming and starting delivery. This may potentially lead to under- or over-delivery.