223 Items Found

on september 26, 2018 oscor notified customers of a recall for ce... on september 26, 2018 oscor notified customers of a recall for ce...
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oscor inc. issues recall product expansion of tb – temporary bipolar pacing lead (unshrouded 2 mm pins models)

...Drugs ...11/13/2018

on september 26, 2018 oscor notified customers of a recall for certain lots (recall no. 1035166- 09/07/2018-01-r) of tb unshrouded bipolar pacing leads. as part of the recall correction activities, oscor is retrieving any remaining inventory out in the field. the recall scope is being expanded to include expired inventory for devices distributed between december 21, 2011 to may 17, 2018. the recall expansion is to ensure proper disposition of expired units. the fda has been notified and is aware oscor inc. is voluntarily taking this action.

sandoz inc. sandoz inc.
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sandoz inc. issues voluntary nationwide recall of one lot of losartan potassium and hydrochlorothiazide due to the detection of trace amounts of ndea (n-nitrosodiethylamine) impurity found in the active pharmaceutical ingredient (api)

...Drugs ...11/9/2018

sandoz inc. is voluntarily recalling one lot of losartan potassium hydrochlorothiazide tablets, usp 100mg/25mg to the consumer level. this product is being recalled due to the trace amount of an impurity, n-nitrosodiethylamine (ndea) contained in the api losartan, usp manufactured by zhejiang huahai pharmaceutical co. ltd. sandoz inc. losartan potassium hydrochlorothiazide product is manufactured by lek pharmaceuticals dd, ljubljana, slovenia. this impurity, which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, has been classified as a probable human carcinogen as per international agency for research on cancer (iarc).

kadesh, inc. kadesh, inc.
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kadesh incorporation issues voluntary nationwide recall of puriton eye relief drops due to non-sterile production conditions

...Drugs ...11/7/2018

kadesh, inc. of garden grove, ca is voluntarily recalling all lots of puriton eye relief drops, 0.5 oz. (15ml) bottle, upc 7 36972 1679 0, to the consumer level. during a recent fda inspection, investigators observed that ophthalmic drugs, which are required to be sterile, are manufactured without necessary production controls and conditions to assure sterility.

janssen pharmaceuticals, inc. janssen pharmaceuticals, inc.
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janssen issues voluntary nationwide recall for one lot of ortho-novum 1/35 and two lots of ortho-novum 7/7/7 due to incorrect veridate dispenser instructions

...Drugs ...11/3/2018

janssen pharmaceuticals, inc. has initiated a voluntary recall of one lot of ortho-novum 1/35 (norethindrone / ethinyl estradiol) tablets and two lots of ortho-novum 7/7/7 (norethindrone / ethinyl estradiol) tablets to the pharmacy level. the patient information provided inside affected packages of ortho-novum does not include the appropriate instructions for the veridate dispenser.

sciegen pharmaceuticals, inc. sciegen pharmaceuticals, inc.
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sciegen pharmaceuticals, inc. issues voluntary nationwide recall of irbesartan tablets, usp 75 mg, 150 mg, and 300 mg due to the detection of trace amounts of ndea (n-nitrosodiethylamine) impurity found in the active pharmaceutical ingredient (api)

...Drugs ...10/30/2018

sciegen pharmaceuticals, inc. is voluntarily recalling listed lots, within expiry, of irbesartan tablets, usp 75 mg, 150 mg, and 300 mg dosage forms to the consumer level. these products are being recalled due to the presence of an impurity, n-nitrosodiethylamine (ndea) contained in the api irbesartan, usp manufactured by aurobindo pharma limited. this impurity, which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, has been classified as a probable human carcinogen as per international agency for research on cancer (iarc)

aurobindo pharma limited is voluntarily recalling 22 batches of t... aurobindo pharma limited is voluntarily recalling 22 batches of t...
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aurobindo pharma limited issues voluntary recall of irbesartan drug substance due to the detection of trace amounts of ndea (nnitrosodiethylamine) impurity found in the active pharmaceutical ingredient (api)

...Drugs ...10/29/2018

aurobindo pharma limited is voluntarily recalling 22 batches of the drug substance irbesartan due to the presence of an impurity, n-nitrosodiethylamine (ndea). the impurity, which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, has been classified as a probable human carcinogen as per international agency for research on cancer (iarc).

promise pharmacy is voluntarily recalling one lot of prednisolone... promise pharmacy is voluntarily recalling one lot of prednisolone...
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promise pharmacy issues voluntary nationwide recall of prednisolone and gatifloxacin ophthalmic solution 1%/0.5% sterile due to small particulate floating in the solution

...Drugs ...10/22/2018

promise pharmacy is voluntarily recalling one lot of prednisolone and gatifloxacin ophthalmic solution 1%/0.5% sterile, 3ml vials, to the patient consumer level. the product has been found to have unidentified small particulate floating in the solution.

fat burners zone is voluntarily recalling 1 lot of zero xtreme, c... fat burners zone is voluntarily recalling 1 lot of zero xtreme, c...
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fat burners zone issues voluntary nationwide recall of zero xtreme due to presence of undeclared sibutramine

...Drugs ...10/15/2018

fat burners zone is voluntarily recalling 1 lot of zero xtreme, capsules to the consumer level. fda analysis has found zero xtreme to be tainted with sibutramine. sibutramine is an appetite suppressant that was withdrawn from the u.s. market due to safety concerns. the presence of sibutramine in zero xtreme renders it an unapproved drug for which safety and efficacy has not been established and, therefore, subject to recall.

liveyon, llc liveyon, llc
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liveyon, llc issues a voluntary nationwide recall of the regen series ® product, manufactured by genetech, inc.

...Drugs ...10/10/2018

liveyon, llc (“liveyon”) is a distributor of stem cell products manufactured by genetech, inc. (“genetech”), a laboratory located in san diego, ca. liveyon marketed and distributed these products under the trade name regen series®. liveyon has voluntarily recalled all regen series® products due to reported possible adverse reactions.

eight and company llc eight and company llc
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sprayology issues voluntary nationwide recall of homeopathic aqueous-based medicines due to microbial contamination

...Drugs ...10/10/2018

eight and company llc, d/b/a sprayology is voluntarily recalling all lots within expiry from 10/18-7/22 of its aqueous-based homeopathic product line for human use. all products manufactured by the contract manufacturer, king bio, have been recalled due to possible microbial contamination.

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