for immediate release – peapack, nj, november 16, 2017 - greenstone llc, a wholly owned subsidiary of pfizer inc., is voluntarily recalling multiple lots of diphenoxylate hydrochloride and atropine sulfate tablets, usp to the consumer level. greenstone initiated this recall because product from these lots has the potential to be super potent or sub potent.
baxter international inc. announced today it is voluntarily recalling one lot of nexterone (amiodarone hcl) 150 mg/100 ml premixed injection – distributed between 6/23/2017 and 10/2/2017 in the united states to wholesalers/distributors and healthcare facilities – due to the potential presence of particulate matter. the particulate matter may have entered the solution during the manufacturing process.
ridge properties dba pain relief naturally is voluntarily recalling all lots within expiry of naturally hl bedsore relief cream, extra strength pretat by tat balm carbomer free gel and extra strength naturally hl hemorrhoid numbing with lidocaine manufactured by ridge properties dba pain relief naturally, salem, oregon to the consumer level. these products are being recalled after an fda inspection found significant violations of current good manufacturing practice regulations.
fresenius kabi usa is voluntarily recalling lot 6400048 of midazolam injection, usp, 2 mg/2 ml packaged in a 2 ml prefilled single-use glass syringe to the hospital/user level. the product mislabeled as midazolam injection, usp, 2 mg/2 ml contains syringes containing and labeled as ondansetron injection, usp, 4 mg/2 ml.
sca pharmaceuticals llc (“sca pharmaceuticals”) is voluntarily recalling all/the following lots of the below listed injectable products to the hospital level. the is a potential for the products to contain microbial contamination. administration of a drug product, intended to be sterile, that may contain microbial contamination has the potential to result in serious adverse events which may include life-threatening infections.
ngày 5 tháng mu?i, 2017-manvel, tx, kiriko, llc. xin thu h?i t? nguy?n t?t c? các lô hàng a1 slim d?ng l? ch?a 30 viên con nh?ng ? c?p d? ngu?i tiêu dùng. phân tích trong phòng thí nghi?m c?a fda dã phát hi?n r?ng s?n ph?m a1 slim có l?n các ch?t sibutramine, phenolphthalein và n-desmethyl sibutramine.
baxter international inc. announced today it is voluntarily recalling one shipment from a single lot of intralipid 20% iv fat emulsion, 100 ml, distributed between 8/11/17 and 8/31/17 to hospitals and healthcare providers in the united states, to the user level. the product has been exposed to subfreezing temperatures during transit to a distribution facility. the subfreezing temperature is outside of the acceptable storage range listed on the product labeling. other shipments of this lot are not affected by this issue.
genentech, a member of the roche group (six: ro, rog; otcqx: rhhby), is voluntarily recalling three lots of activase® (alteplase) 100mg vials, that were co-packaged with sterile water for injection, to the hospital level. the vials of sterile water for injection, manufactured by hospira inc., a pfizer company, and packaged with activase 100 mg, may be cracked or chipped at the neck of the vial and leaking.
pharmedium services, llc (pharmedium) is voluntarily recalling all unexpired lots of oxytocin compounded with lactated ringers and all unexpired lots of oxytocin compounded with lactated ringers and dextrose products that were produced between july 6, 2017 and august 29, 2017 to the hospital/user level. the recall is being issued based on laboratory test results indicating a lower than expected potency on certain lots of oxytocin compounded with lactated ringers and oxytocin compounded with lactated ringers and dextrose which would lead to a lower dose being administered.
hospira, inc., a pfizer company, is voluntarily recalling one lot of hydromorphone hci injection, usp, cii (2 mg/ml) 1mg/ml vial and four lots of levophed® (norepinephrine bitartrate injection, usp), 4 mg/4 ml (1 mg/ml) vial due to a potential lack of sterility assurance resulting from use of a damaged sterilizing filter for nitrogen used in the manufacturing process. to date, hospira, inc., a pfizer company has not received any reports of adverse events related to this recall.