Navinta Fomepizole Injection, 1.5 g/1.5 mL (1 g/mL), For Intravenous Infusion only recall — FDA D-0431-2015
Lack of Assurance of Sterility. A recent FDA inspection reported GMP violations potentially impacting product quality and sterility.
Complete FDA and NHTSA recall records dated in 2015, organized for browsing by month, category and recalling company.
Select a month to review the recall records reported during that period.
Records are ordered by the best available source date.
Lack of Assurance of Sterility. A recent FDA inspection reported GMP violations potentially impacting product quality and sterility.
Non-Sterility: Out of specification results for the sterility test for microbial contamination.
Non-Sterility: Out of specification results for the sterility test for microbial contamination.
Non-Sterility: Out of specification results for the sterility test for microbial contamination.
Failed Impurities/Degradation Specifications: out of specification results for a related compound - a degradant of fexofenadine.
Presence of Particulate Matter: Confirmed customer complaints received for the presence of blue plastic, identified as fragments of the frangible from the vial adapter.
Non-Sterility: Out of specification results for the sterility test for microbial contamination.
Non-Sterility: Out of specification results for the sterility test for microbial contamination.
Non-Sterility: Out of specification results for the sterility test for microbial contamination.
Failed Impurities/Degradation Specifications: A stability lot was out of specification for a known impurity at the 8 month Controlled Room Temperature stability time-point.
Non-Sterility: Out of specification results for the sterility test for microbial contamination.
San Juan Salsa Co. is recalling six varieties of salsa due to potential peanut contamination.
Christ Kitchen is recalling Blameless Blondies, a dry bakery mix, because milk, soy and wheat allergens are not declared in product labeling.
Sub ingredient of Worcestershire sauce (anchovy) was not listed on finished product label.
One packaging run of 8 oz. Classic Red Hearts with Assorted Chocolates was packaged in the wrong box and does not include tree nuts in the ingredient statement.
Recall of Granny Smith Apples from 2014 harvest used in caramel apple production due to their association with Listeriosis outbreak. Expansion of recall on January 6, 2015 to include all…
Fiesta Pacific is recalling all Brown Label Horchata due a formulation error and no process on file to prevent the growth of potentially harmful bacteria, including Clostridium botulinum.
Smoked herring may be potentially contaminated with C. botulinum.
Tai Foong USA, Inc. is recalling Northern Chef Lightly Coated Cod Fingers because the contains statement fails to identify eggs. Eggs are declared in the ingredient statement.
Cumin may contain undeclared peanut protein.
The Company is recalling the Mrs. Fields White Chunk Macadamia cookies because the package is not compliant with the requirements of FALCPA to recognize the presence of the macadamia…
The products contain cumin that may be contaminated with undeclared peanut allergens.
WhiteWave Foods is voluntarily recalling 7.5 oz packages of Horizon Cheddar Sandwich Crackers because they may contain undeclared peanuts due to an inadvertent packaging error. The outer…
San Juan Salsa Co. is recalling six varieties of salsa due to potential peanut contamination.
This archive groups records by their reported or recall date. It does not imply that every recall was initiated, announced and resolved during the same calendar year. Open the individual record for the exact dates and source details supplied by FDA or NHTSA.