Entries by Heather Davis

Cronus Pharma LLC initiating Voluntary Recall for (Dexased™ -Aspen and Dexmedvet™ -Cronus Pharma LLC) of Dexmedetomidine Hydrochloride Injection 0.5 mg/mL For Veterinary Use Due to Presence of Particulate Matter

East Brunswick, NJ, April 23, 2025 - CRONUS PHARMA LLC, on behalf of Cronus Pharma Specialities, Hyderabad, India is issuing a voluntary recall involving one batch comprising two distinct lots: Dexased™ (Aspen) and Dexmedvet™ (Cronus Pharma LLC). Both ...

Source: Food and Drugs Administration--Recalls/Safety Alerts

Cronus Pharma LLC initiating Voluntary Recall for (Dexased™ -Aspen and Dexmedvet™ -Cronus Pharma LLC) of Dexmedetomidine Hydrochloride Injection 0.5 mg/mL For Veterinary Use Due to Presence of Particulate Matter

East Brunswick, NJ, April 23, 2025 - CRONUS PHARMA LLC, on behalf of Cronus Pharma Specialities, Hyderabad, India is issuing a voluntary recall involving one batch comprising two distinct lots: Dexased™ (Aspen) and Dexmedvet™ (Cronus Pharma LLC). Both ...

Source: Food and Drugs Administration--Recalls/Safety Alerts

FDA Classifies Q’Apel Medical Inc.’s Worldwide Medical Device Recall and Discontinuation of its 072 Aspiration System (Hippo) as Class I

On April 7, 2025, the U.S. Food and Drug Administration (“FDA” or “the agency”), classified Q’Apel Medical, Inc.’s (“Q’Apel” or “the company”) voluntary recall of 1,617 units of its 072 Aspiration System (also known under the product name “Hippo”, whic...

Source: Food and Drugs Administration--Recalls/Safety Alerts

FDA Classifies Q’Apel Medical Inc.’s Worldwide Medical Device Recall and Discontinuation of its 072 Aspiration System (Hippo) as Class I

On April 7, 2025, the U.S. Food and Drug Administration (“FDA” or “the agency”), classified Q’Apel Medical, Inc.’s (“Q’Apel” or “the company”) voluntary recall of 1,617 units of its 072 Aspiration System (also known under the product name “Hippo”, whic...

Source: Food and Drugs Administration--Recalls/Safety Alerts

Amneal Pharmaceutical LLC Issues a Nationwide Recall of Ropivacaine Hydrochloride Injection, USP 500mg/100mL, Due to the Potential Presence of Particulate Matter

Bridgewater, NJ, Amneal Pharmaceutical LLC, is recalling two lots of Ropivacaine Hydrochloride Injection, USP, 500mg/100mL, Infusion bags to the hospital/user level as the products may contain an inert fiber identified as polypropylene fibers from the ...

Source: Food and Drugs Administration--Recalls/Safety Alerts

Amneal Pharmaceutical LLC Issues a Nationwide Recall of Ropivacaine Hydrochloride Injection, USP 500mg/100mL, Due to the Potential Presence of Particulate Matter

Bridgewater, NJ, Amneal Pharmaceutical LLC, is recalling two lots of Ropivacaine Hydrochloride Injection, USP, 500mg/100mL, Infusion bags to the hospital/user level as the products may contain an inert fiber identified as polypropylene fibers from the ...

Source: Food and Drugs Administration--Recalls/Safety Alerts