Comments related to this drug product pilot program, even after the program has ended can be sent to fda is conducting a pilot program seeking to expedite notifications of human drug product recalls to the public ..
Cefdinir for oral suspension, 125 mg5 ml, packaged in a) 60 ml bottle (ndc ) b) 100 ml bottle (ndc ), rx only, teva pharmaceuticals usa, sellersville, pa 18960 ..
Oxycodone and acetaminophen tablets usp 10mg325 mg, rx only, ndc 4778123001 warfarin sodium tablets, usp crystalline, 2 mg, rx only, 1) 100 tablet bottle (ndc 5) 2) 1000 tablet bottle (ndc 5) ..
Zemplar (paricalcitol) capsule, 1mcg, 30 count bottle, rx only, ndc dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate tablets, 30 mg, 100 ct ..
Ndc 5 pantoprazole sodium, delayed release tablets 40 mg, rx only, ndc label mixup some cartons labeled to contain pantoprazole sodium tablets actually contain lorazepam tablets and vice versa day time cold & flu, multi-symptom, non-drowsy, acetaminophen, dextromethorphan hbr, phenylephrine hcl, 6, 8, and 10 oz bottles, otc only ..
Publix corporate parkway, lakeland, fl 33811, ndc 5, upc 0 41415 39573 2 i) careone infants dye-free pain relief acetaminophen suspension liquid, 2 fl oz (59 ml) bottle, distributed by foodhold u ..
Cincinnati, ohio 45202, ndc 3, upc 0 41260 35832 6 2 fl oz lot 3hk0564, exp 0615 3hk0672, exp 0615 3jk0594, exp 0715 3jk0595, exp 0815 3kk0815, exp 0815 4 fl oz lot 3gk0645, exp 0615 lot 3jk0653, exp 0715 3jk0433, exp 0715 3kk0817, exp 0815 3jk0673, exp 0815 3kk0494, exp 0815 3kk0360, exp 0815 defective delivery system there is a remote potential that cartons of product could be co-packaged with an oral dosing syringe without dose markings. Lot 30304253a, exp 1213 b) lot 30304144a, exp 124477a, exp 0314 defective container this recall is being carried out due to the potential for improperly sealed bottles. Valeant pharmaceuticals north america llc, 400 somerset corporate blvd, bridgewater, nj 08807 doxycycline, usp capsules 40 mg, packaged in 30 ct bottles, rx only, ndc 6 labelingincorrect or missing lot andor exp date some expiries and lot numbers are missing vancomycin for injection, usp, 10 g, 100 ml vials, rx only, ndc sulfacetamide sodium ophthalmic solution usp 10 , sterile, rx only, ndc 1 defective delivery system may have a low frequency assembly fault which may result in pens block during the so-called air shot coppertone sunscreen lotion clearly sheer, spf 50, 5 fl oz (147 ml), upc 00041100005762 labeling product contains undeclared api product back label does not indicate oxybenzone (active) and octyldodecanol (excipient) sclerosol intrapleural aerosol canisters (sterile talc powder 4 g.
Mings chinese capsule (ginger 50 mg, camellia sinensis 50 mg, malus domestica 50 mg, propetary blend 300 mg cynara scolymus, hoodia, sirulina, chitosan, 60-count bottles, distributed by natural products, doral, fl 33178. Propofol injectable emulsion 1, 1g100ml 100ml single patient infusion vial, rx only, ndc lot 07-950-dj exp. Single-dose, ndc presence of particulate matter visible free floating and partially embedded particulate matter in the glass vials a) b-50 capsules, 100-count bottle, healthy life chemistry by purity first, manufactured for purity first health products, inc.
Bentonville, az 72716, ndc 4, upc 0 78742 09060 3 b) leader infants pain & fever acetaminophen suspension, distributed by cardinal health, dublin, oh 43017, ndc 3, upc 0 96295 12093 6 c) topcare infants pain & fever acetaminophen, distributed by topco associates llc, elk grove village, il 60007, ndc 3, upc 0 36800 34645 1 d) walgreens infants pain & fever acetaminophen oral suspension, distributed by walgreen co. Lot 3992j141, expiry 5j142, expiry 5b151, expiry 7b151, expiry 7a151, expiry 7a151, expiry 7b151, expiry 8f151, expiry 11e151, expiry 11c151, expiry 11c151, expiry 11e151, expiry 11h151, expiry 2h151, expiry 317, lot 3654h151, expiry 3k151, expiry 3k151, expiry 4k151, expiry 4k151, expiry 4m151, expiry 517. Cincinnati, ohio 45202, ndc 3, upc 0 41260 35829 6 h) publix infants painrelief acetaminophen suspension liquid, 2 fl oz (59 ml), distributed by publix super markets, inc.
Venlafaxine (venlafaxine hcl) extended release, 225 mg, rx only, a) 30 count (ndc ) and b) 90 count (ndc 0) tablets lot a) 58975, 58976, 58977, 65165, exp 114 b) 58973, 58974, 65131, exp 114 failed dissolution specifications some tablets do not meet the specification for dissolution at the 12 hour time point at 18 months of product shelf life. Portable sips batch 07099, exp august 200 exp august 20, exp october 20 exp november 2015batch 19023 exp january 209, exp march 209 exp april 200, exp july 200 exp september 202 exp august 200, exp december 200, exp august 202, exp july 201, exp april 202, exp june 203, exp april 200 exp september 200 exp october 203 exp january 209 exp september 200 exp february 202 exp february 203 exp march 2018 10 x 1 ml cartons batch 15030 exp february 202 exp november 2017. Rx, ndc 0430 0389 24 slimdia revolution capsules, 30-count capsules per bottle, yerba naturals, 19685 varda ave.
Ndcs distributed by private labels) 79305114a 79305114b 79305114c 79305114d 79305114e 79305114f exp 052015 microbial contamination of non-sterile product out-of-specification microbial results were obtained at the initial stability interval for lansoprazole delayed release capsules. Labeling missing text on the product insert in the clinical studies and specific adverse events sections. Amoxicillin capsules usp 500 mg, rx only, 1) 30 count bottle, (ndc ) 2) 500 count bottle (ndc ) ck2003, ck2004 exp.
Total volume 100 ml, single dose container, preservative free (contains sulfites), ndc 7 lack of assurance of sterility product observed with leaks at the seam of the bag potassium chloride added to 0. Deerfield, il 60015, ndc , upc 3 11917 13225 9 e) kroger infants pain & fever acetaminophen suspension liquid, distributed by the kroger co. Correct labeled product mispack ifosfamide injection 50 mgml, 60 ml, correctly labeled vial may have been mis-packaged in a carton labeled doxorubicin hydrochloride injection 2 mgml, 100 ml fentanyl citrate inj. Sodium chloride injection, usp, packaged in a) 50 ml single dose viaflex plastic containers (product code 2b1308, ndc ) and b) 100 ml single dose viaflex plastic containers (product code 2b1302, ndc ) and (product code 2b1309, ndc ), rx only, baxter healthcare corporation, deerfield, il 60015 usa. Box 99, pleasnton, ca 94566, ndc 2 kk) select brand, 6 fl oz, distributed by select brand distributors, pine bluff, ar 71603, ndc 1 ll) select brand, 10 fl oz, distributed by select brand distributors, pine bluff, ar 71603, ndc 1 mm) shoprite, 10 fl oz, distributed by wakefern food corporation, 5000 riverside drive, keasbey, nj 08832, upc 0 41190 22274 2 nn) western family, 12 fl oz, proudly distributed by western family foods, inc.
Sodium chloride injectable, 1 mg per ml, total volume 100 ml, single dose container (total morphine dose 100 mg 100 ml), preservative free (contains sulfites, ndc 7 fentanyl (as citrate) in 0. Lake forest, il 60045, ndc presence of particulate matter brass particulates were identified in the primary container in the form of several small greybrown particles. Distributed by bryan corporation, woburn, ma 01801 defective delivery system defective stem valve caused leakage of the propellant in the spray canister causing no drug or an inadequate amount of the drug to be delivered 50 magnesium sulfate injection, usp, 10 g20 ml (0. Bicnu (carmustine) for injection kit, 100 mg and diluent, kit (ndc ) contains a vial containing 100 mg carmustine (ndc ) and an ampule containing 3 ml sterile diluent kitvial lot (9l7003a1803607), exp 1112 (9h4209a1803608), exp 0113 (9h4211a1843251), exp 0213 (0b7004a1843251), exp 0413 (0b7005a2011804), (0e7004a2011804), exp 0513 (0e7006a2055384), exp 0913 (0j7007a2064024), (1a7005a2064024), exp 0114 (1c7006a2106210), exp 0414 hydromorphone hcl injection, 2 mgml, usp, 1 ml fill in 2. Rx only, ndc 6 lot 13g005p, 13g010p, exp 0616 lot 13h029p, 13j048p, 13j049p, 13j050p, exp 0817 lot 14b047p, 14b048p, 14b049p,14c043p, 14c048p, 14c049p, exp 0118 lot 14d048p, 14d053p, 14d054p, exp 0318 lot 14g042p, 14g047p, 14g049p, exp 518 lot 14j005p, 14j006p, 14j007p, exp 0718 lot14k114p, 14k115p, 14k116p, exp 0918 lot 15b008p, 158013p, 15b021p, 15c058p, 15c059p, 15c064p, exp 0119 lot 15e037p, 15e038p exp 0419.
Udl laboratories) rockford illinois 61103-1201 failed impuritiesdegradation specifications out of specification result for known impurity at 6 month timepoint baclofen, 2. Dextrose 50 in sterile water, 50 ml single dose vial compounded by specialty medicine compounding pharmacy, south lyon, mi all sterile products compounded by specialty medicine compounding pharmacy, south lyon, mi. Methylphenidate hydrochloride extended-release capsules ,1) 20 mg, 100 count bottle, (ndc ), 2) 30 mg 100 count bottle (ndc ) 3) 40mg 100 count bottle 1) 34010282a, 34010283a, 34010284a, 34010285a, 34010286a and 34010565a, exp 0414 34013199a, 34013200a, 34013201a, 34013202a and 34013203a, exp 1014 defective container small micro fracture observed in the 2-liter bottle at the fill line resulting in a small leak when patient reconstitutes the bulk powder 1) errin(r) (norethindrone tablets, usp), 0. Healthy life chemistry 51 florida street, farmingdale, ny 11735 b) multi-mineral capsules, 200-count bottle, healthy life chemistry by purity first, manufactured for purity first health products, inc. First aid antiseptic lots jt23210, jt23210, jt25810, jt27610, jt31510, jt35610, jt04811, jt05311, jt11811, jt13211, jt15911, jt15911, jt15211, jt18211, jt18211, jt21511-1 manufacturer jiangsu province, jianerkang medical dressing co.
Rock-it man capsules, male sexual stimulant, packaged in 1-count (upc 8 53447 02003 8) and 2-count (upc 8 53447 00204 1) blister cards, distributed by consumer concepts. The information will be continue to be provided in a narrative format until fda has decided upon the method to include it in the new enforcement report format. Union, nj 07083 usa, upc 3 70030 51018 4 acetaminophen suspension liquid, 160 mg5 ml, cherry flavor, 2 fl oz (59 ml) bottle co-packaged with an oral dosing syringe in a carton and sold under the following a) leader infants pain & fever acetaminophen suspension, distributed by cardinal health, dublin, ohio 43017, ndc 3, upc 0 96295 12095 0 b) walgreens infants pain & fever acetaminophen oral suspension, distributed by walgreen co. Kit for ophthalmic use, ndc 4 non sterile one or more parts in the kit have been found to contain a strain of yeast identified as rhodotorula-bacarum isoniazid tablets, usp, 300 mg, 30 tablet bottles, rx only, ndc 6 and 100 tablet bottles ndc 6 super power capsules, proprietary blend 570 mg, packaged in 2-count capsules per blister pack, distributed by freedom trading nj 08863, upc 7 18122 90678 9 marketed without an approved ndaanda product was found to contain trace amounts of sildenafil, an fda approved drug for the treatment of male erectile dysfunction, making super power an unapproved new drug. Batch 15030 exp february 202 exp november 2017 10 x 1 ml batch 09020 exp january 202, exp april 2017. Paclitaxel injection (semisynthetic) 300mg5ml ( 6mgml) multiple dose vial (ndc 6), rx only lot numbers and expiration dates 871za00201, 112013 871za00301, 112013 871za00302, 112013 871za00401, 112013 871za00402, 112013 872za00101, 122013 872za00201, 122013 872za00301, 122013 872za00401, 122013 and, 872za00501, 122013. Columbus, ohio 43216 ethambutol hydrochloride tablets usp, 400 mg, 100-count bottles, rx only, manufactured for lupin pharmaceuticals, inc. Rx, ndc enablex (darifenacin) extended release tablet, rx 15 mg per tablet, ndc bupropion hydrochloride extended-release tablets, usp, 100 mg, 10 x 10 unit-dose tablets, rx, ndc 6(single dose) ndc 6 (carton) defective container package defect of blister cards caused stability failures at the 9 month timepoint for discolored tablets, dissolution and related compounds assessment prednisone tablets usp 20 mg, 10 x 10 unit-dose tablets, rx only, ndc labeling missing label little or no printing on paper backing of blister cards merrem i. Marketed without an approved ndaanda fda analysis found the products to contain undeclared sibutramine, a previously approved fda product indicated for weight loss that was removed from the market for safety reasons, making these products unapproved new drugs. Portable sips batch 20010, exp december 2014 (10 x 1ml) batch 25050, exp april 2015.Will I have to work shifts? buy cheap irbesartan “Constellation moves Vertu design ..... How many weeks' holiday a year are there? lisinopril hctz 10 12.5 mg tab ...... slopes of the Rockies and prairie farmlandsdownstream the week before last, ...... and a grand prix in New Jersey are the two novelties planned for 2014 with ...