simple diagnostics, is voluntarily recalling three lots of pharmacist choice alcohol prep pads (upc # 898302001050, ndc # 98302-0001-05), which were manufactured by foshan flying medical products co. ltd., located in china, due to the lack of sterility assurance and other quality issues.
sun pharmaceutical industries, inc. (spii), a wholly owned subsidiary of sun pharmaceutical industries ltd. (reuters: sun.bo, bloomberg: sunp in, nse: sunpharma, bse: 524715, “sun pharma” including its subsidiaries and/or associate companies) is voluntarily recalling two lots of riomet® (metformin hydrochloride oral solution), 500 mg/5ml, to the retail level (class ii recall). this product is manufactured for spii by a contract manufacturer. the riomet® (metformin hydrochloride oral solution) has been found to be contaminated (scopulariopsis brevicaulis). the contamination was discovered during sample preparation for the antimicrobial preservative effectiveness testing (ampet) being performed as part of the 12 month stability study interval.
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.