All Recalls

Failed Impurities/Degradation Specifications:Out-of-Specification result for Hydrocortisone related impurity and slightly lower than the established level of the Hydrocortisone Assay obtained during stability testing.

Crystallization: presence of white, crystalline product agglomeration observed in 2 vials during annual inspection of retain samples.

Presence of Foreign Tablet(s)/Capsule(s): A foreign tablet was found in a bottle of Montelukast Sodium Tablets, USP 10mg, identified as metoprolol 25 mg.

Failed Dissolution Specifications-out-of-specification (OOS) test results observed for dissolution at the 6 month long term time point.

Labeling: Wrong Barcode- One (1) of every forty (40) unit dose blister will contain incorrect barcode information that causes a 125mcg unit dose is scanned as 200mcg unit dose.

CGMP deviations: the product was shipped from the Manufacturer to a Medline warehouse and released to stock while it was still under investigation for low assay results on the active ingredient miconazole nitrate.

Sub-potent Drug: Lower potency than labeled.

Failed Dissolution Specifications: Out of specification for dissolution.

Presence of Particulate Matter: identified as glass.

Potential for units suspended on the ceiling to fail and fall.

There is a risk of endobronchial combustion if high-frequency cauterization is performed while supplying oxygen [and/or] the electrode section of the electrosurgical accessory is too close to the distal end of the endoscope.

Endobronchial implant devices may have been labeled with a shortened expiration date but they can be used until the correct expiration date: 08 December 2024.

Products were stored outside of labeled temperature requirements.

Sterilization failures when devices are sterilized per the Reprocessing Manual due to lack of drying time for the endoscope channel.

An error was identified on the expiration date of the product label. The shelf life for the products impacted is 36 months (3 years) however the product label represents a 54 month (4.5 year) shelf life.

Potential for units suspended on the ceiling to fail and fall.

Inadvertent release of embolectomy catheters that may experience slower than normal balloon deflation (greater-than 15 seconds).

It was found that the fixation (weld) employed by the supplier of the nut bolt to the slide rail plate was insufficient. The deficient weld allows the nut bolt to break off from the slide rail plate with slight manual force.

An error was identified on the expiration date of the product label. The shelf life for the products impacted is 36 months (3 years) however the product label represents a 54 month (4.5 year) shelf life.

Products were stored outside of labeled temperature requirements.