Recalls

Recall of unexpired sterile drug product lots by Infusion Options Inc. due to lack of sterility assurance.

Recall of unexpired sterile drug product lots by RXQ Compounding, LLC (“RXQ”) due to lack of sterility assurance.

Recall of unexpired sterile drug product lots by Premier Pharmacy Labs due to lack of sterility assurance.

Recall of Advance Enforcer 35 Focal-Force PTA balloon catheter 6mm x 4cm by Cook Medical due to balloons bursting below the rated burst pressure.

Recall of losartan potassium to 50 mg and 100 mg tablets USP by Teva Pharmaceuticals USA due to impurity.

Recall of Candy King - Worms 3 mg 100 mL by Drip More due to elevated nicotine.

Recall of PECGEN DMX by NOVIS PR due to labeling error.

Recall of SOLOPATH Balloon Expandable TransFemoral System and Re-Collapsible Balloon Access System by Terumo Medical Corporation due to dislodgement of the fairing tip from the sheath.

Recall of amikacin sulfate injection, USP 1gm/4 mL (250mg/mL) and prochlorperazine edisylate injection, USP 10mg/2mL (5mg/mL) by Heritage Pharmaceuticals due to sterility test failure.

Recall of veterinary products by Norbrook Laboratories Limited due to potential lack of sterility.

Recall of all sterile compounded drugs by Pharm D Solutions due to potential lack of sterility.

Recall of LimiTorr Volume Limiting CSF Drainage System and the MoniTorr ICP External CSF Drainage and Monitoring System by lntegra LifeSciences due to possible breakage.

Recall of EV1000 Clinical Platforms by Edwards Lifesciences due to electrical short circuit.

Recall of DxH 800, DxH 600, and DxH 900 hematology analyzers by Beckman Coulter Life Sciences due to sporadic erroneously elevated platelet count results without flags or system messages.

Recall of circular staplers by Ethicon due to failure to completely form staples.

Recall of Promacta (eltrombopag) 12.5 oral suspension by Novartis due to potential peanut contamination.

Recall of The Beast capsules by STIFF BOY due to undeclared sildenafil.

Recall of mycophenolate mofetil for injection by Par Pharmaceutical due to glass fragment observed in one vial of reconstituted product.

FDA issued recall of losartan potassium 25 mg, 50 mg and 100 mg tablets by Vivimed Life Sciences due to trace amounts of n-nitroso-n-methyl-4-aminobutyric acid (NMBA) impurity.

FDA issued recall of ketorolac tromethamine injection by Sagent Pharmaceuticals due to lack of sterility assurance.

FDA issued recall of bevacizumab 1.25mg/0.05mL 31G injectable by AmEx Pharmacy due to reported defective delivery system.

FDA issued recall of Miller balloon atrioseptostomy catheter and Fogarty dilation atrioseptostomy catheter by Edwards Lifesciences due to balloon deflation, fragmentation and detachment Issue.

FDA issued recall of Fentanyl Transdermal System by Alvogen due to product mislabeling.

FDA issued recall of Losartan Potassium Tablets, USP and Losartan Potassium/Hydrochlorothiazide Tablets, USP by Torrent Pharmaceuticals due to impurity.