FDA Drug Recalls
180 recalls, newest first
Dec 21, 2020
Class II · Moderate risk
Lack of assurance of sterility: The results of sterility tests of seven batches of product were out of specification. Five of these batches tested positive for Ralstonia pickettii and two batches produced turbid results that could not be further identified. While all product distributed to the market has met the registered specifications for release, including for sterility, it was manufactured on the same equipment as the affected batches.
Dec 17, 2020
Class II · Moderate risk
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Dec 17, 2020
Class II · Moderate risk
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Dec 17, 2020
Class II · Moderate risk
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Dec 17, 2020
Class II · Moderate risk
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Dec 17, 2020
Class II · Moderate risk
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Dec 17, 2020
Class II · Moderate risk
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Dec 17, 2020
Class II · Moderate risk
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Dec 17, 2020
Class II · Moderate risk
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Dec 17, 2020
Class II · Moderate risk
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Dec 17, 2020
Class II · Moderate risk
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Dec 17, 2020
Class II · Moderate risk
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Dec 17, 2020
Class II · Moderate risk
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Dec 17, 2020
Class II · Moderate risk
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Dec 17, 2020
Class II · Moderate risk
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Dec 17, 2020
Class II · Moderate risk
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Dec 17, 2020
Class II · Moderate risk
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Dec 17, 2020
Class III · Low risk
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Dec 17, 2020
Class II · Moderate risk
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Dec 17, 2020
Class II · Moderate risk
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Dec 17, 2020
Class II · Moderate risk
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Dec 17, 2020
Class II · Moderate risk
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Dec 17, 2020
Class II · Moderate risk
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Dec 17, 2020
Class II · Moderate risk
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Dec 17, 2020
Class II · Moderate risk
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit