hospira, inc., a pfizer company, is voluntarily recalling lots 72680ll and 76510ll of naloxone hydrochloride injection, usp, 0.4 mg/ml, 1 ml in 2.5 ml, carpuject single-use cartridge syringe system (ndc 0409-1782-69), to the hospital/institution level due to the potential presence of embedded and loose particulate matter on the syringe plunger.
abbott is communicating to physicians about a field corrective action related to the heartmate 3™ left ventricular assist device (lvad). abbott notified physicians and global regulatory bodies on april 5, 2018, that outflow graft twisting could occur post-implant in the heartmate 3 lvad, resulting in a persistent low flow alarm that may signal a potential safety risk to patients, such as low blood flow or clotting.
apotex corp. is voluntarily recalling one (1) lot of fluticasone propionate nasal spray, usp, 50 mcg per spray, 120 metered sprays, to the consumer level. the fluticasone propionate nasal spray usp 50 mcg per spray 120 metered sprays has been found to contain small glass particles. the glass particles could block the actuator and impact the functionality of the pump. the issue was discovered through a customer complaint.
allergan plc (nyse:agn) today issued a voluntary recall in the us market of one lot (lot# 5620706, expiry may-2019) of taytulla® (norethindrone acetate and ethinyl estradiol capsules and ferrous fumarate capsules) 1mg/20mcg, 6x28 physicians sample pack, indicated for use by women to prevent pregnancy. allergan recently identified, through a physician report, that four placebo capsules were placed out of order in a sample pack of taytulla. specifically, the first four days of therapy had four non-hormonal placebo capsules instead of active capsules.
shadow holdings is voluntarily recalling all lots, within expiry, of herb-x solutions x-jow pain gel, and united exchange acne shave moisturizer, acne shave shave cream with acne shield, and acne shave shave kit to the retail level. the products may be contaminated with bacteria.
mbi distributing, inc. is voluntarily recalling all lots of homeopathic teething drops, nausea drops, intestinal colic drops, stomach calm, expectorant cough syrup, silver-zinc throat spray, and argentum elixir, within expiry, to the consumer level. the drug products have been found to be manufactured with a lack of adequate controls.
shoreside enterprises, inc. is voluntarily recalling 7k (lot specific: lot #ro) and poseidon 4500 (extreme 1000 mg) (lot specific: lot #20117bl) to the consumer level. fda analysis found the samples of these products to contain undeclared sildenafil and/or tadalafil. sildenafil and tadalafil are active ingredients in two fda-approved prescription drugs used for the treatment of erectile dysfunction (ed).
apotex corp. is voluntarily recalling 36 lots of piperacillin and tazobactam for injection, usp 3.375 gram/vial and 4.5 gram/vial strengths, to the consumer/user level. the piperacillin and tazobactam for injection have been found to contain elevated levels of impurities that may result in decreased potency. the affected product is manufactured by hospira inc., a pfizer company and distributed in the us market by apotex corp.
east windsor, new jersey, auromedics pharma llc is voluntarily recalling two lots of piperacillin and tazobactam for injection, usp 3.375 g (piperacillin sodium equivalent to 3 g of piperacillin usp and tazobactam sodium equivalent to 0.375 g of tazobactam usp. each vial contains 7.05 meq (162 mg) of sodium) in a single-dose vial, to the hospital level. the products have been found to contain particulate matter, visible only after reconstitution that was confirmed to be glass within the vial.
auromedics pharma llc is voluntarily recalling two lots of ampicillin and sulbactam for injection usp, 3 grams*/ single-dose vial, to the hospital/user level. the recall has been initiated due to customer complaints of the presence of red particulate matter in the product that is believed to be red rubber particles from the manufacturing process of the active ingredients.