95,064 total recalls in our database
Ranier's Compounding Laboratory
Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.
Northwind Pharmaceuticals
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Lupin Pharmaceuticals
Presence of Foreign Substance: Product complaint was received of metal contaminant observed in one tablet.
Ranier's Compounding Laboratory
Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Ranier's Compounding Laboratory
Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.
Ranier's Compounding Laboratory
Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.
Dr. Reddy's Laboratories
Failed Impurities/Degradation Specifications - OOS was observed for ATV Cyclo FP Impurity and Total Degradation Impurities tested at the 18 month stability time point in Atorvastatin Calcium Tablets 40 mg 500 tablets.
Mislabeled hook pouch included a transport/storage label rather than the product label containing key product information such as part number, lot number, and expiration date, etc
There is a potential for imaging artifact to mimic calcifications on patient's mammograms
ICU Medical de Mexico, S.A. de C.V.
ICU Medical is expanding the scope of their previously initiated recall to include additional I.V. Administration Sets with NanoClave manifold due to the potential to develop a leak or for separation between the female luer and the NanoClave manifold.
There is a potential for imaging artifact to mimic calcifications on patient's mammograms
ICU Medical de Mexico, S.A. de C.V.
ICU Medical is expanding the scope of their previously initiated recall to include additional I.V. Administration Sets with NanoClave manifold due to the potential to develop a leak or for separation between the female luer and the NanoClave manifold.
Merit Medical Systems
Supplier manufacturing defect with the syringe plunger tip.
The packaging may not be sealed. If the packaging is compromised in this manner, the sterility of the product cannot be guaranteed.
Zimmer Biomet
Two lots of the Echo BI-Metric Hip Stem and ARCOS Modular Revision Hip Stem may have been comingled. Potential health consequences include extension of surgery time to find a replacement component.
QFix has advised Mevion Medical Systems that they are identifying unauthorized combinations of QFix Couch Tops with non-QFix devices in clinical use. The kVue Oen Touch latch consists of a precision latch mechanism that can be damaged when used with incompatible (third-party) accessories. This can create unsafe conditions for use and may compromise the subsequent use of any kVue inserts, whether authorized or not. Use of unauthorized or unvalidated inserts may lead to an incorrect patient treatment or physical injury.
ICU Medical de Mexico, S.A. de C.V.
ICU Medical is expanding the scope of their previously initiated recall to include additional I.V. Administration Sets with NanoClave manifold due to the potential to develop a leak or for separation between the female luer and the NanoClave manifold.
Arkon Anesthesia Delivery System may go into a failed state (mechanical ventilation ceases) while the machine is in use or while idle.
Clarity Diagnostics LLC discovered specific lots of Clarity 10SG Strips are not compatible for use in the Clarity Urocheck 120 Urine Analyzers, due to lack of Canister Code Bar Code Label.