cGMP deviation: Product held outside of appropriate temperature storage conditions.
All Recalls
95,102 total recalls in our database
Colgate Anticavity Fluoride Toothpaste, OPTIC WHITE with CHARCOAL COOL MINT PASTE, Net Wt. 4.2 OZ. UPC 0 35000 97872 1. Dist. by: Colgate-Palmolive Company New York, NY 10022 U.S.A.
Family Dollar Stores
cGMP deviation: Product held outside of appropriate temperature storage conditions.
Identification of an unknown impurity at the 12-month stability point. Further investigation has identified the impurity as Timolol Phenol S-Oxide.
Neomycin Sulfate Tablets, USP 500 mg , 100-count bottles, Rx only, Distributed by: TEVA PHARMACEUTICALS USA, INC North Wales, PA 19454, NDC 0093-1177-01
Teva Pharmaceuticals USA
CGMP Deviations: A foreign matter identified as teflon was found in the Active Pharmaceutical Ingredient (API) used in the manufacture of Neomycin Sulfate Tablets, USP 500 mg.
Labeling: Product Contains Undeclared API - product contains undeclared ethyl alcohol
Colgate Whitening Mouthwash, OPTIC WHITE ICY FRESH MINT. 16 fl. OZ. (1 pt) 473 mL UPC 0 35000 67111 0. Dist. by: Colgate-Palmolive Co. New York, NY 10022 U.S.A.
Family Dollar Stores
cGMP deviation: Product held outside of appropriate temperature storage conditions.
CGMP Deviations: Product complaints reporting the product to have a gritty texture and lack of effectiveness.
Colgate Anticavity Fluoride Toothpaste, OPTIC WHITE ADVANCED ICY FRESH, Net Wt. 3.2 OZ. (90 g) UPC 0 35000 97159 3. Dist. by: Colgate-Palmolive Company New York, NY 10022 U.S.A.
Family Dollar Stores
cGMP deviation: Product held outside of appropriate temperature storage conditions.
Colgate Anticavity Fluoride Toothpaste OPTIC WHITE STAIN FIGHTER CLEAN MINT PASTE. Net Wt. 4.2 OZ. (119 g) UPC 0 35000 45836 0. Dist. by: Colgate-Palmolive Company New York, NY 10022 U.S.A.
Family Dollar Stores
cGMP deviation: Product held outside of appropriate temperature storage conditions.
cGMP deviation: Product held outside of appropriate temperature storage conditions.
Labeling: Product Contains Undeclared API - product contains undeclared ethyl alcohol
Aesculap ENNOVATE SET SCREW STERILE-implants are used for dorsal monosegmental and multisegmental stabilization of the lumbar, thoracic and sacral spine. Article Number: 52758014
Aesculap Implant Systems
Potential for the incorrect screw to be included in the package.
Pentacam AXL REF 70100, Pentacam HR REF 70900. Used to image the anterior segment of the eye.
Oculus Optikgeraete GMBH
Due to a software issue, IOL calculator printout often does not accurately reflect the alignment axis and incision position when planning toric IOLs
Procedure packs contained a recalled product.
Artis icono biplane- Model No. 11327600 Artis icono floor- Model No. 11327700
Siemens Medical Solutions USA
Siemens has become aware of a potential hardware issue with Artis Q, Artis Q.zen, Artis pheno and Artis icono systems with a specific lot of X-ray tubes. In rare cases, if the error detection mechanism fails, it will not be possible to release X-ray any longer until system shutdown.
ARCHITECT STAT Troponin-I Reagent Kit, REF 2K41-27
Abbott Laboratories
One lot of reagent was manufactured with insufficient quantities of the heterophilic blocking agents in the conjugate component.
There are 7 reported software anomalies that may affect use of the device.
T-Cell Xtend REF TTK.610 US
OXFORD IMMUNOTEC
Due to equipment failure, affected products were stored at temperatures outside the validated range of 2-8 degree C for a period longer than the validated storage time.
There is potential for unanticipated software anomalies to occur when using the Model 2868 Application loaded on the 3120 ZOOM LATITUTDE programmer when communicating with certain Boston Scientific transvenous defibrillators.
Dimension Vista LOCI CA 15-3 Flex reagent cartridge. In Vitro Diagnostic for the quantitative measurement of CA 15-3. Siemens Material Number (SMN)/Ref Catalog Number : 10464344/K6456
Siemens Healthcare Diagnostics
Negative bias with patient samples. The mean patient sample bias range from -26% to -33%,potential risk of delay in appropriate treatment and management decisions.