All recalls7,877 total
Product lacks 510(k) clearance.
Product lacks 510(k) clearance.
Product lacks 510(k) clearance.
Product lacks 510(k) clearance.
Product lacks 510(k) clearance.
Product lacks 510(k) clearance.
Product lacks 510(k) clearance.
Product lacks 510(k) clearance.
Product lacks 510(k) clearance.
Product lacks 510(k) clearance.
Product lacks 510(k) clearance.
Product lacks 510(k) clearance.
Product lacks 510(k) clearance.
Product lacks 510(k) clearance.
Product lacks 510(k) clearance.
Product lacks 510(k) clearance.
Product lacks 510(k) clearance.
Product lacks 510(k) clearance.
Milk not listed in Contains statement
Egg not listed in Contains statement
Potential foreign material (stainless steel fragments)
Milk not declared as the major food allergen source for the ingredient Whey
Wheat not listed in Contains statement
Undeclared wheat and egg
Undeclared egg
Incorrect back label on product resulting in undeclared allergens (wheat, eggs)
Possible foreign object contamination (plastic).
Possible foreign object contamination (plastic).
Non-Sterility: contamination of Aspergillus penicillioides, due to breach in package lidding.
Labeling: Label Error on Declared Strength. Overwrap labeled as Potassium Chloride Inj 10 mEq may contain flexible containers of Potassium Chloride Inj 20 mEq
Failed Impurities/Degradation Specifications
Labeling: Label Error on Declared Strength. Cases labeled POTASSIUM CHLORIDE 20 mEq, may contain flexible containers with overwrap mislabeled as 10 mEq. The correct dosage strength of 20 mEq is printed on the labeling affixed to the product flexible container.
Failed Impurities/Degradation Specifications
Defective Container: broken or leaking bottles.
Customer complaints of bottles foaming when opened
Foreign material found in product (bolt)
Foreign material found in product (bolt)
Undeclared allergen (walnuts)
Foreign material found in product (bolt)
Lack of assurance of sterility and cGMP deviations observed at the manufacturing site.
The near-infrared therapy device contains a lithium-ion battery that may malfunction, causing it to catch fire or burst into flames.
Elevated levels of MBC (carbendazim) thiophanate-methyl.
Potential Foreign material (plastic)
Lack of Assurance of Sterility: There is a potential for leakage at the IV bottle port.