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.
ama wholesale inc. (distributor/re-seller), is voluntarily recalling rhino 69 extreme 50000 capsules to the consumer level. fda analysis found the product to be tainted with undeclared tadalafil. tadalafil is an active ingredient in a fda-approved prescription drug that is used for erectile dysfunction.
microbial contamination was detected during routine testing of subsequent unreleased product lots due to interaction between the product syringe and tamper evident container closure, which may result in the potential introduction of microorganisms into the products.
para publicación inmediata - 29 de marzo de 2018 - el segundo, ca, marcasusa, llc e industria farmacéutica andromaco, s.a. de c.v. están retirando voluntariamente tres lotes de pasta de lassar andromaco protector de la piel con 25% de óxido de zinc, en tubos de 60 gramos, al nivel minorista. el análisis de la fda de este producto confirmó que pasta de lassar andromaco está contaminado con altos niveles de bacterias y hongos. el lote específico asociado a los hallazgos positivos se puso en cuarentena y se destruyó, ninguna pieza fue vendida en los ee. uu. sin embargo, debido a la cantidad y el tipo de contaminación, los tres lotes restantes en el mercado de los ee. uu. se retiran como una gran medida de precaución. el uso del producto contaminado podría aumentar el riesgo de infección. hasta la fecha, marcasusa no ha recibido ningún informe de eventos adversos relacionados con este retiro del mercado.
for immediate release – march 29, 2018 – el segundo, ca, marcasusa, llc and industria farmacéutica andromaco, s.a. de c.v. is voluntarily recalling four lots of pasta de lassar andromaco skin protectant, 25% zinc oxide to the retail level. fda analysis of this product confirmed that pasta de lassar andromaco is contaminated with high levels of yeast, mold, and bacteria. the specific lot associated to the positive findings was never sold in the us. however, due to the amount and type of contamination the remaining four lots in the us market are being recalled out of an abundance of caution. use of the contaminated product could result in an increased risk of infection. to date, marcasusa has not received any reports of adverse events related to this recall.
bd (becton, dickinson and company) (nyse: bdx), a leading global medical technology company, today announced it is updating the instructions for use of certain bd vacutainer® tubes as part of its quality process to ensure that customers understand the appropriate uses of these products.