torrent pharmaceuticals limited is voluntarily recalling 14 lots of valsartan/amlodipine/hctz tablets to the consumer level due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (api) manufactured by zhejiang huahai pharmaceuticals. the impurity detected in the api is n-nitrosodimethylamine (ndma), which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, and has been classified as a probable human carcinogen as per international agency for research on cancer (iarc) classification.
world organix llc, is voluntarily recalling lot: 112710 of blissful remedies red maeng da 100% mitragyna speciosa capsules, blissful remedies red maeng da liquid kratom mitragyna speciosa, blissful remedies 4 hour chill slow motion blend to the consumer level. these products have been tested by the u.s. food and drug administration (“fda”) and found to be contaminated with high microbial loads. additionally, this serves as a update to a previous press release posted on june 30th 2018, concerning blissful remedies gold series ultra enhanced indo and blissful remedies kratom+cbd, cbd infused maeng da, red maeng da 100% mitragyna speciosa, recalled due to salmonella contamination, where blissful remedies was listed as the recalling firm instead of world organix llc. to date, world organix llc has not received reports of adverse events related to these recalls.
westminster pharmaceuticals, llc is voluntarily recalling all lots, within expiry, of levothyroxine and liothyronine (thyroid tablets, usp) 15 mg, 30 mg, 60 mg, 90 mg, & 120 mg to the wholesale level. these products are being recalled as a precaution because they were manufactured using active pharmaceutical ingredients that were sourced prior to the fda’s import alert of sichuan friendly pharmaceutical co., ltd., which as a result of a 2017 inspection were found to have deficiencies with current good manufacturing practices (cgmp). substandard cgmp practices could represent the possibility of risk being introduced into the manufacturing process.
as a precautionary measure, camber pharmaceuticals, inc. is voluntarily recalling all unexpired lots of valsartan tablets, usp, 40mg, 80mg, 160mg and 320mg to the hospital, retail and consumer level. this recall of multiple batches of valsartan tablets was prompted due to the detection of trace amounts of n-nitrosodimethylamine (ndma), a possible process impurity or contaminant in an active pharmaceutical ingredient, manufactured by hetero labs limited, unit – i (api manufacturer).
holly hill, fl, product quest manufacturing (“product quest”) is voluntarily recalling lot# 173089j of cvs health 12 hour sinus relief nasal mist, a clear, colorless liquid, to the consumer level. the product was found to have had microbiological contamination identified as pseudomonas aeruginosa.
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. one vial from lot# pp0317012-a was found to contain particulate matter, identified as glass within the vial and another vial from lot# pp0317059-a was found to contain silicone material. this problem was discovered as a result of two product complaints in which the contents of one vial from batch pp0317012-a was found to contain a glass particle and the contents of one vial from batch pp0317059a was found to contain a silicone particle.
ranier’s rx laboratory is voluntarily recalling all sterile compounded drug products within expiry to the hospital or consumer level. these drug products are being voluntarily recalled due to concerns that practices at the pharmacy have the potential to pose a risk of contamination to products that are intended to be sterile. these concerns arose following a routine inspection of the pharmacy by fda.
king bio is voluntarily recalling four lots of aquaflora candida hp9, lymph detox, and baby teething liquids to the consumer level. during a routine inspection by the u.s. food and drug administration, the products were found to contain microbial contaminants pseudomonas brenneri, pseudomonas fluroescens and burkholderia multivorans.
teva pharmaceuticals usa today confirmed a voluntary recall to the consumer / user level of 29 lots of single and 51 lots of combination valsartan medicines distributed under the actavis label in the u.s. due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (api) manufactured by zhejiang huahai pharmaceutical. the impurity detected in the api is n- nitrosodimethylamine (ndma), which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, and has been classified as a probable human carcinogen as per international agency for research on cancer (iarc) classification.
as a precautionary measure, the distribution firm, major pharmaceuticals, is issuing a nationwide voluntary recall of all lots within expiry of valsartan which were supplied by teva pharmaceuticals and labeled as major pharmaceuticals.