Class I · High risk
MINERAL IV Injection
Non-Sterility; analytical results found product to contain Sphingomonas paucimobilis
FDA Drug Recalls
13 recalls · Class I, newest first
Class I · High risk
Calcium Gluconate 10% for Injection
Non-Sterility: RX Formulation initiated this recall due to a report of microbial contamination found in Calcium Gluconate saturated solution that was observed upon drawing the vial contents into a syringe.
Class I · High risk
Glycopyrrolate
Non-Sterility: One lot of Glycopyrrolate solution for injection was found to be contaminated with Bacillus thuringiensis.
Class I · High risk
Dextrose* Vial In Sterile Water
Non-Sterility: 50% dextrose is being recalled after particulate matter, later identified as mold, was found floating in the product.
Class I · High risk
Carboxymethylcellulose Sodium 0.5% Ophthalmic Solution
Non-Sterility: Customer complaints of mold in the product after use and handling due to the fact that the preservative used in the lots of Carboxymethylcellulose Sodium 0.5% Ophthalmic Solution may not be effective through expiry.
Class I · High risk
CALCIUM GLUCONATE 2 gm
Non Sterility: Microbial contamination
Class I · High risk
Calcium Chloride Preservative Free Sterile injection
Non-Sterility: The firm's contract testing laboratory found sterility failures.
Class I · High risk
Trace Mineral-5 MDV
Non-Sterility; contract laboratory identified Staphylococcus warneri in the product
Class I · High risk
Class I · High risk
Sermorelin/GHRP-6
Lack of Assurance of Sterility: The recall is being initiated due to a lack of sterility assurance and concerns associated with the quality control processes identified during an FDA inspection.
Class I · High risk
HCG (Lyophilized)
Lack of Assurance of Sterility: The recall is being initiated due to a lack of sterility assurance and concerns associated with the quality control processes identified during an FDA inspection.
Class I · High risk
Lactated Ringer's and 5% Dextrose Injection
Non-Sterility: Confirmed customer complaint of product contaminated with mold.
Class I · High risk
Mitosol (mitomycin for solution)
Non-Sterility: one or more components of the kit have been found to be contaminated with yeast.