Vereinigte Staaten Recalls

Morphine Sulfate Injection, USP, 2 mg /mL, 1 mL single-dose Simplist prefilled syringes, For Intramuscular or Intravenous use, Rx only, Fresenius Kabi, Lake Zurich, IL. Unit of Use NDC Number 76045-004-01; Unit of Sale NDC Number 76045-004-11

Labeling: Label Mixup: MicroVault labeled as Morphine 2 mg/1 mL, contains a Prefilled Syringe of Dilaudid 0.5 mg/0.5 mL.

Carbamazepine Tablets, USP, 200mg, 1000 count bottles, Rx only, Manufactured by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel 2624761, Distributed by: Taro Pharmaceuticals USA, Inc., Hawthorne, NY 10532, NDC 51672-4005-3.

CGMP Deviations; black spots found on tablets from burnt excipient during manufacturing

Gifford's HomeMaine ice cream brand POWER PLAY FUDGE; ONE QUART (946 mL); UPC: 8 60864 00030 7

Potential foreign object contamination: rubber pieces

Protein Cereal Cocoa Crunch. Shelf stable, ready to eat cereal product. 25-year shelf life, metalized poly pillow pouch. Net wt.8.9 oz (252g). 1 pillow pouch per kit. Nutrient, 110 Woodland Ave Reno, NV 89523. No UPC Not for individual retail sale

Soy not declared in the contains statement.

Blanketrol III, Model 233; Thermal regulating system.

Overheating of the 115V CPU board may cause the device to shut down.

Siemens Healthineers Immulite 2000 Systems SYP Syphilis Screen REF:L2KSY2(D)/10471981 IVD, RxOnly

Syphilis Screen assay may contain a negative patient bias resulting in low reactive patient results being reported as nonreactive.

niCARdipine Hydrochloride Injection, USP, 25 mg/10mL (2.5 mg/mL), packaged in a) 10 mL Single Dose Vial (NDC 72572-470-01) and b) 10x10 mL Single Dose Vials (NDC 72572-470-10), Rx Only, Mfd for: Civica, Inc., Lehi, UT, Mfd by: American Regent, Inc., New Albany, OH 43054.

Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde

PEMRYDI RTU(pemetrexed injection), 500 mg/50 mL (10 mg/mL), Single-dose vial, Rx only, Manufactured by: Zydus Lifesciences Limited, Ahmedabad, India; Distributed by: Amneal Pharmaceuticals LC, Bridgewater, NY 08807. NDC: 70121-2461-1

Discolored solution. The firm has received market complaints reporting green to dark green discoloration in certain vials

Tralement (trace elements injection 4*, USP), packaged in a) 1mL Single Dose vials (NDC 0517-9305-01) and b) 5x1mL Single Dose vials (NDC 0517-9305-25), Rx only, AMERICAN REGENT, INC., SHIRLEY, NY 11967.

Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde

AMINAOCAPROIC ACID INJECTION, USP, 250 mg/mL (5 g/20 mL), packaged in a) 20 mL MULTIPLE DOSE VIAL FOR IV INFUSION (NDC 0517-9120-01), and b) 25x20 mL MULTIPLE DOSE VIALS (NDC 0517-9120-25), Rx Only, American Regent, Inc., Shirley, NY 11967.

Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde

Syva EMIT 2000 Quinidine Assay REF: 4Q019UL Contents: 1x28 mL, 1x14mL

Due to unacceptable precision performance exhibited in certain lots of the Emit 2000 Quinidine Assay, which may lead to erroneously elevated quinidine measurements, creating risk of sub-optimal patient treatment, including potential life-threatening cardiac arrhythmias or inadequate antimalarial therapy.

Custom Made Device Implant 6123 Navicular Cage Nominal Right Rev A, Model/Catalog Number 6123N R; foot implant

Device was recalled due to an elevated oxygen level in excess of the allowable limit. Elevated oxygen levels may contribute to reduced material ductility.

Paragonix Technologies Inc. KidneyVault Portable Renal Perfusion System REF# PRGNX-8008-001

Due to a firmware defect, the portable organ transfer device datalogger may lose its configuration, resulting in a blank screen and loss of displayed preservation parameters.

Selenious Acid Injection, USP 12 mcg/2 mL (6 mcg/2mL), For intravenous use, packaged in a) 2mL Single-Dose Vial (NDC 0517-6502-01), and b)10x2mL Single-Dose Vial (NDC 0517-6502-10), Rx Only, AMERICAN REGENT, INC., SHIRLEY, NY 11967.

Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde

Bell Sports, Inc. - Helmets with Inadequate Impact Protection/FMVSS 218

A helmet that does not provide adequate impact protection increases the risk of injury in a crash.

Brand Name: Veritas Standard Reverse Total Shoulder Product Name: Veritas Standard Glenoid Baseplate Model/Catalog Number: 1500-1030; 1500-1035 Software Version: N/A - off-the-shelf hardware product Product Description: The restor3d Reverse Total Shoulder Arthroplasty System is intended for patients requiring a reverse shoulder replacement for patients with a functional deltoid muscle and with a deficient rotator cuff. The restor3d Reverse Total Shoulder Arthroplasty System consists of the glenoid baseplate, glenosphere intraoperatively affixed to the baseplate, humeral stem, and polymer bearing component affixed to the humeral stem. Additionally, the system includes supporting standard instrument trays and all required accessories (e.g., security screws, peripheral screws). The restor3d rTSA System is indicated for use in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy and/or previously failed shoulder joint replacement with a grossly deficient rotator cuff. The Veritas standard glenoid baseplate is the only component within scope of this field action. The patient-specific baseplate is unaffected by this defect and therefore not in scope. Component: Reverse Total Shoulder

Due to incorrect machining of peripheral screw hole resulting in potential for improper engagement of the peripheral screws.

Acamprosate Calcium, Delayed-Release Tablets, 333 mg, 180 tablets bottles, Rx only, Mylan Pharmaceuticals Inc., Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 266505, NDC 0378-6333-80.

Failed Dissolution Specifications

Esteem Body Soft Convex Urostomy Pouch Model/Catalog Numbers: 423703, 423704, 423705, 423707, 423708, 423709, 423710, 423712, 423713, 423714, 423715, 423716, 423717, 423718, 423721, 423722, 423723, 423725, 423726, 423727.

Urostomy Pouches may leak from cap during use.

Boston Scientific ENROUTE Transcarotid Neuroprotection System Plus, Material Number SR-250-NPS; Percutaneous catheter

Potential for arterial sheath tip separation or partial tip separation during use.

BD Needle Kit for Powered Driver 15mm x 15Ga, REF: D015151NK, BD Needle Kit for Powered Driver 25mm x 15Ga, REF: D015251NK, BD Needle Kit for Powered Driver 35mm x 15Ga, REF: D015351NK, BD Needle Kit for Powered Driver 45mm x 15Ga, REF: D015451NK, BD Needle Kit for Powered Driver 55mm x 15Ga, REF: D015551NK

After placement of intraosseous (IO) needle sets, used when intravenous access is difficult or impossible to obtain in emergent, urgent, or medically necessary cases, users may experience difficulty/inability to remove obturator, due to it locking to the needle hub, due to out-of-tolerance dimensions and IFU unclarity, which may result in new needle placement, which may result in delayed therapy

Revival Animal Health, LLC Voluntarily Recalls Feline Milk Replacers Due to Inconsistent Levels of Vitamins and Trace Minerals

Shanghai Ravioli Corporation Recalls Not Ready-To-Eat Frozen Buffalo Chicken Products Produced Without the Benefit of Inspection

Produced Without Benefit of Inspection

Baxter Issues Voluntary Nationwide Recall for One Lot of Anticoagulant Sodium Citrate Solution Due to Potential Presence of Particulate Matter

Beckman Coulter, Emit 2000 Quinidine Assay REF: OSR4Q229 Contents: R1: 2 x 23 mL;R2 2x13 mL

Due to unacceptable precision performance exhibited in certain lots of the Emit 2000 Quinidine Assay, which may lead to erroneously elevated quinidine measurements, creating risk of sub-optimal patient treatment, including potential life-threatening cardiac arrhythmias or inadequate antimalarial therapy.