All recalls8,521 total
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.
Potential metal inclusion
Product contains cyclamates.
Undeclared Sesame, Soy, Wheat, Yellow No. 5, Yellow No. 6, and Red No. 6.
CGMP Deviations
CGMP Deviations
The Bodor i Series products fail to meet certain applicable Federal standards, 21 CFR 1040.10(f)(1) and 21 CFR 1040.10(f)(2).
Sprouts have the potential to be contaminated with Listeria monocytogenes
Defective Container: Some packets may not be fully sealed, potentially allowing for loss of Ethanol from the product.
Failed Dissolution Specifications
Foreign object (metal pieces).
Potential contamination with blue pieces of plastic
Entering multiple keys that trigger input simultaneously may remove data from first field of screens and/or questionnaires with more than one field.
Product's easy-pull lid was not secured properly and may cause the product to become adulterated with the hazard clostridium botulinum.
Product's easy-pull lid was not secured properly and may cause the product to become adulterated with the hazard clostridium botulinum.
Product's easy-pull lid was not secured properly and may cause the product to become adulterated with the hazard clostridium botulinum.