APS BioGroup DPS Throat Spray, UPC 8 55602 00021 3 recall — FDA F-1480-2019
The recall is being conducted as a result of elevated APC levels. Through additional testing, it was determined that the organism is Stenotrophomonas maltophilia.
Complete FDA and NHTSA recall records dated in 2019, 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.
The recall is being conducted as a result of elevated APC levels. Through additional testing, it was determined that the organism is Stenotrophomonas maltophilia.
The recall is being conducted as a result of elevated APC levels. Through additional testing, it was determined that the organism is Stenotrophomonas maltophilia.
FDA inspection found that allergen sub ingredients are not declared on the label - wheat, soy, milk.
Product was labeled as gluten free by mistake, but the product does contain Gluten.
Testing of Fexofenadine HCl and Pseudoephedrine Failed Impurities/Degradation Specifications: elevated substance results that were reported above or near the specification limit
CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
Testing of Fexofenadine HCl and Pseudoephedrine Failed Impurities/Degradation Specifications: elevated substance results that were reported above or near the specification limit
CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
Testing of Fexofenadine HCl and Pseudoephedrine Failed Impurities/Degradation Specifications: elevated substance results that were reported above or near the specification limit
cGMP Deviations: Firm was notified by their supplier of Cetirizine HCL Oral Solution, USP, 1mg/mL, 4oz, of the voluntary recall that they have initiated due to potential contamination with…
CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
Labeling: Label mix-up: Product secondary carton erroneously states 40mg instead of 30 mg, primary carton is label correctly.
CGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
cGMP Deviations: Firm was notified by their supplier of Cetirizine HCL Oral Solution, USP, 1mg/mL, 4oz, of the voluntary recall that they have initiated due to potential contamination with…
cGMP Deviations: Firm was notified by their supplier of Cetirizine HCL Oral Solution, USP, 1mg/mL, 4oz, of the voluntary recall that they have initiated due to potential contamination with…
CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
Testing of Fexofenadine HCl and Pseudoephedrine Failed Impurities/Degradation Specifications: elevated substance results that were reported above or near the specification limit
Subaru of America, Inc. (Subaru) is recalling certain 2019 Legacy and Outback vehicles. Spot welds located on the duct below the cowl panel may have been improperly applied, impacting the…
There has been a reported incident of a Distar CRT monitor that has fallen off the monitor wall mount related to product aging.
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.