Class I · High risk
N-Acetyl Cysteine 20% 4 mL Vial Stock Code: 4133
Non-Sterility: One lot of N-Acetyl Cysteine vials tested positive for Herbaspirillum huttiense.
FDA Drug Recalls
150 recalls · Class I, newest first
Class I · High risk
LACTATED RINGER'S and 5% DEXTROSE Injection USP
Non-Sterility: Confirmed customer complaint of particulate matter floating within the solution of the primary container, consistent with mold.
Class I · High risk
Ascorbic Acid 500 mg/mL Sterile Injection
Non-Sterility: Pharmacy Creations is recalling Ascorbic Acid 500 mg/mL 50 mL vials due to mold contamination.
Class I · High risk
Dianeal PD-2 Peritoneal Dialysis Solution with 1.5% Dextrose
Non-Sterility: Complaints of leaks and particulate matter identified as mold in the solution bag and the overpouch.
Class I · High risk
MINERAL IV Injection
Non-Sterility; analytical results found product to contain Sphingomonas paucimobilis
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.
Class I · High risk
Cyanocobalamin 1000 mcg/ml
Non-Sterility: Green Valley Drugs received positive sterility results from their testing lab on two lots of Methylprednisolone Preservative Free 40 mg/mL injectable suspension and one lot of Cyanocobalamin 1000 mcg/mL injection, 30 mL MDV.
Class I · High risk
Methylprednisolone Preservative Free 40 mg/ml Injectible Suspension
Non-Sterility: Green Valley Drugs received positive sterility results from their testing lab on two lots of Methylprednisolone Preservative Free 40 mg/mL injectable suspension and one lot of Cyanocobalamin 1000 mcg/mL injection, 30 mL MDV.
Class I · High risk
Lactated Ringer's and 5% Dextrose Injection
Non-Sterility: One confirmed customer report that product contained spore-like particulates, consistent with mold.
Class I · High risk
Methylprednisolone Acetate 80 mg/mL Injection
Non-Sterility
Class I · High risk
Methylprednisolone Acetate 40 mg/mL Injection
Non-Sterility
Class I · High risk
Methylprednisolone Acetate
Non-Sterility
Class I · High risk
Methylprednisolone Acetate
Non-Sterility
Class I · High risk
Merit Convenience Kits containing Cytosol Ophthalmics Balanced Salt Solution
Lack of Assurance of Sterility: Procedure kits contain a balanced salt solution that may be contaminated with endotoxins.