Recall: Remote possibility of an unintended ingredient delivery as a result of a damaged valve actuator on the EM 2400 used to compound intravascular administration

FDA Enforcement Report dated May 20, 2012, found here, includes the following recall.

PRODUCT

The EM 2400 is a Pharmacy Compounding System consisting of three sub-systems for compounding solutions for intravascular administration. Pharmacy compounding system for mixing ingredients for intravascular administration. Recall # Z-1371-2012

CODE

Units: 30248; 30304; 30577; 30578; 30600; 30321; 30264; 30507; 30256; 30120; 30587; 30778; 30779; 30512; 30218; 30136; 30260; 30549; 30612; 30940; 30268; 30415; 30949; 30300; 30435; 30162; 30269; 30356; 30291;30464; 30915; 30916; 30235; 30136; 30150; 30394; 30704; 30705; 30180; 30134; 30207; 30208; 30376; 30419; 30420; 30510; 30534; 30547; 30548; 30583; 30589; 30590; 30591; 30629; 30630; 30644; 30645; 30654; 30661; 30674; 30686; 30687; 30698; 30699; 30702; 30703; 30707; 30708; 30739; 30752; 30756; 30759; 30765; 30772; 30791; 30793; 30800; 30801; 30816; 30830; 30831; 30836; 30842; 30843; 30869; 30870; 30886; 30899; 30900; 30932; 30935; 30936; 30937; 30938; 30950; 30961; 30962; 30963; 30970; 30981; 30984; 30985; 30997; 31003; 30004; 31027; 31028; 31035; 31036; 31055; 31056; 31074; 31077; 31080; 31081; 31084; 31085; 31097; 31118; 31119; 31120; 31129; 31134; 31142; 31161; 31162; 31163; 31169; 31170; 31171; 31172; 31173; 31174; 31181; 31182; 31194; 31201; 31211; 31212; 31213; 31214; 31215; 31216; 31216; 31217; 31224; 31237; 31238; 31262; 31263; 31264; 31265; 31267; 31268; 31269; 31270; 30918; 30706; 31266; 30943; 30527; 30138; 30323; 30651; 30241; 30515; 30805; 31061; 30440; 30441; 31240; 31006; 30818; 30297; 30798; 30331; 30677; 30579; 30105; 30362; 30287; 30194; 30384; 30489; 30544; 30863; 30203; 30148; 30332; 30978; 30993; 30994; 30360; 30697; 31053; 31054; 31141; 30934; 30137; 31001; 31002; 31029; 31030; 30769; 30770; 30771; 30237; 31104; 31105; 30809; 30810; 31271; 31272; 30727; 31123; 30299; 30341; 30274; 30316; 30141; 30142; 30678; 30679; 30855; 30856; 30490; 30382; 30982; 30983; 30201; 30202; 31179; 31180; 30977; 30799; 30389; 30397; 30465; 30478; 30624; 30443; 30234; 30422; 30242; 30551; 30251; 30781; 30296; 30225; 30638; 30976; 31071; 30722; 30367; 30611; 30819; 30820; 30483; 30484; 30192; 30258; 30974; 30885; 30214; 30290; 30572; 30712; 30787; 30461; 30313; 30523; 30754; 30767; 30682; 30393; 30184; 30343; 30398; 30400; 30616; 30617; 30500; 30574; 30554; 30161; 30567; 30609; 30975; 30280; 31050; 30245; 30806; 30302; 30724; 30294; 30675; 31019; 31020; 30528; 30576; 30462; 30713; 30479; 30480; 30850; 30851; 31015; 31016; 30432; 30780; 30757; 30758; 30584; 30733; 30734; 30605; 30995; 30844; 30231; 30450; 30874; 31116; 31117; 30680; 30117; 30355; 31115; 30346; 30841; 31127; 30627; 30882; 30187; 30349; 30325; 30447; 30580; 30785; 30449; 30491; 30506; 30348; 30598; 30354; 30681; 30919; 31076; 30966; 30967; 30498; 30511; 30466; 30471; 31064; 30575; 30164; 30205; 30838; 31110; 30672; 30725; 30620; 30621; 30613; 30570; 30639; 30944; 30945; 30658; 30660; 31033; 31044; 31057; 30571; 30236; 30906; 30179; 31195; 31196; 30539; 30540; 30334; 30335; 30659; 30939; 30175; 30240; 31051; 30210; 31258; 31259; 30545; 30550; 30320; 30615; 30927; 30928; 30387; 30417; 30959; 30960; 30951; 30952; 30531; 30532; 30622; 30130; 30160; 30255; 30503; 30504; 30846; 30636; 30603; 31025; 31034; 30730; 30633; 30738; 30115; 30156; 30372; 30433; 30606; 30783; 30177; 30493; 31075; 30488; 31017; 30773; 30775; 30525; 30533; 30804; 30135; 30267; 30340; 30463; 30894; 30941; 30889; 30481; 30494; 30709; 30796; 30872; 30381; 30890; 30876; 30198; 30157; 30229; 30526; 30111; 30273; 31072; 31073; 30634; 30723; 30221; 30296; 30676; 31018; 30835; 30803; 30811; 30924; 30905; 30641; 30642; 30149; 30216; 30595; 30128; 30188; 30185; 30524; 30563; 30152; 30270; 30306; 30505; 31207; 31208; 30369; 30254; 30406; 30497; 30784; 31111; 30469; 30826; 30519; 30520; 30541; 30625; 30688; 31151; 30535; 30536; 30986; 30987; 30197; 30247; 30486; 30592; 31112; 31012; 30305; 30475; 30379; 30812; 31239; 30619; 30343; 30223; 30288; 30366; 30217; 30700; 30174; 30263; 30314; 30685; 30308; 30209; 30204; 30412; 30315; 30378; 30345; 30789; 30508; 30653; 31159; 31160; 30908; 30499; 30683; 31065; 30448; 30477; 30807; 30808; 30742; 30139; 30902; 30903; 31274; 31275; 30664; 30648; 31234; 30485; 30743; 30762; 30763; 30439; 31176; 31177; 30423; 31008; 30565; 30250; 30988; 30989; 30607; 30696; 30509; 30181; 30999; 31000; 30113; 30392; 30404; 30582; 30953; 30414; 30614; 30802; 30892; 30893; 30646; 30259; 30338; 30361; 30405; 30409; 30650; 30145; 30119; 30319; 30109; 31125; 31247; 31248; 30454; 30455; 30719; 30168; 31197; 31198; 30102; 30118; 30887; 30888; 30166; 30167; 30942; 30170; 30626; 30839; 31070; 30468; 30735; 30879; 30881; 30410; 30649; 30909; 30425; 60456; 31078; 31079; 31158; 30750; 30751; 30790; 30200; 31058; 30555; 60556; 30792; 30721; 30618; 30640; 30213; 30310; 30979; 30980; 30964; 30965; 30690; 30647; 30637; 30797; 30521; 30522; 30923; 30322; 30327; 30155; 30232; 30363; 30413; 30849; 30744; 30760; 30821; 30822; 31164; 31249; 31250; 30729; 30858; 30513; 30514; 30529; 30530; 30666; 30667; 30823; 30827; 31100; 30276; 30643; 30342; 30428; 30749; 30153; 30178; 30632; 30635; 30837; 30838; 30560; 30561; 30452; 30453; 30552; 30710; 30401; 30459; 31218; 31219; 30593; 30776; 30176; 30817; 30238; 30239; 30399; 30282; 30782; 30910; 30917; 30265; 30954; 31143; 31144; 30222; 30446; 30657; 30460; 31095; 31031; 31191; 31192; 31149; 30476; 30546; 30227; 30228; 30921; 30922; 30968; 30969; 30144; 30581; 31220; 31221; 31222; 31223; 30226; 30227; 31228; 31230; 31251; 31252; 31253; 31254; 31037; 31038; 31039; 31040; 31041; 31042; 31043; 31045; 31046; 31047; 30693; 30764; 31204; 31205; 31206; 30599; 31145; 31146; 31147; 31148; 31150; 31152; 31153; 31154; 30277; 30492; 30873; 31114; 31005; 31007; 31009; 30114; 30129; 30189; 30328; 30768; 30336; 30585; 31260; 31261; 31087; 31088; 31089; 31090; 31091; 31092; 31093; 31094; 31052; 30601; 30602; 30753; 30122; 30233; 30261; 30788; 30487; 30257; 30861; 30815; 30946; 30226; 30411; 30445; 31010; 30929; 30930; 30430; 30692; 30777; 30230l 31165; 31175; 30329; 30652; 30897; 30898; 30196; 30373; 30182; 30673; 30467; 30597; 30746; 30761; 30472; 31026; 30337; 31062; 31063; 30691; 31121; 30852; 30853; 30374; 30990; 30991; 30971; 30972; 31059; 31060; 30326; 30845; 30813; 31032; 30731; 30732; 30121; 30402; 30668; 30669; 30867; 30868; 30913; 30914; 30370; 30371; 30586; 30588; 30252; 30496; 30594; 30711; 30907; 30391; 30665; 30948; 30748; 30862; 30863; 30127; 31094; 30840; 30243; 30364; 30365; 30235; 30755; 30891; 30517; 30518; 31255; 31256; 30542; 30568; 30281; 30747; 30786; 30537; 30538; 30539; 30726; 30718; 30143; 30824; 30825; 30303; 30694; 30631; 30165; 30737; 30925; 30926; 30333; 30429; 30474; 30794; 30795; 31048; 31848; 30470; 30124; 30864; 30357; 30442; 30623; 30295; 30857; 30878; 30716; 30717; 31103; 30502; 30911; 30912; 31183; 31184; 31186; 31187; 31188; 31225; 30955; 30956; 30318; 30957; 30958; 30834; 30847; 31021; 30559; 30286; 30662; 30663; 31209; 31210; 30740; 30741; 30173; 30195; 31123; 30159; 30163; 30655; 30656; 30358; 30684; 30875; 30877; 30998; 30901; 30436; 31199; 31200; 30407; 30610; 30278; 30418; 30896; 30458; 30101; 30317; 30720; 31229; 31231; 31139; 31140; 30116; 30151; 30173; 30865; 30271; 30895; 30828; 30829; 31022; 31023; 30124; 30344; 30421; 31126; 30132; 30133; 30112; 30253; 31067; 31068; 31185; 30206; 30564; 30880; 30569; 31156; 31157; 31113; 30147; 30171; 30301; 30244; 30285; 30604; 30832; 30833; 30883; 30396; 31108; 31166; 31167; 31168; 30390; 30566; 30158; 30884; 30339; 30292; 31106; 31107; 31189; 31190; 31109; 31135; 31136; 31137; 31138; 30562; 30933; 30596; 30211; 30854; 30860; 31241; 31242; 31243; 31244; 31245; 31246; 30871; 30131; 30859; 31130; 31131; 30293; 30243; 30244; 30110; 30191; 30219; 30714; 30996; 31124; 30154; 31013; 31014; 30108; 31132; 31133; 31098; 31099; 30557; 31066; 31122; 31178; 31257; 31233; 30543; 30106; 31102; 30330; 30424; 31082; 31083

RECALLING FIRM/MANUFACTURER

Baxa Corp., Englewood, CO, by letter dated June 3, 2008. Firm initiated recall is ongoing.

REASON

Remote possibility of an unintended ingredient delivery as a result of a damaged valve actuator on the EM 2400.

VOLUME OF PRODUCT IN COMMERCE

1000 units (approximately)

DISTRIBUTION

Nationwide, Australia, Canada, China, New Zeland, and UK

Doctors using compounding pharmacies to cope with anesthesia drug shortage

Doctors using compounding pharmacies to cope with anesthesia drug shortage

9:05 PM, Mar 8, 2012 by Meredith Mitchell

LITTLE ROCK, Ark. (KTHV) -- Across the country, doctors who use anesthesia drugs are opening up their medicine cabinets to find them nearly empty. The FDA is reporting a shortage of nearly 283 drugs.
Now, many doctors, who perform minor procedures in their offices rely on quick onset and offset anesthesia drugs. But, lately those drugs haven't been readily available.
The anesthesia drug shortage occuring across the country is putting a strain on both doctors and patients.
Little Rock oral surgeon Dr. Joshua Leal says he's having to some fairly big changes.
"When those drugs are not available, it completely alters the way we deliver our anesthetic technique to patients and the way that we deliver our procedure or deliver or treatment to the patient."
Due to the recent shortage, Dr. Leal says he's now using compound pharmacies instead of drug companies for anesthetic.
"Over the past 6 months literally we've had to have compounded at least half of our normal regimen of anesthetic drugs, so that's where not only oral surgeons, but other physicians who administer anesthetics in their office are turning."
Compounding pharmacies purchase chemicals in bulk and formulate prescriptions on-site.
There are just a handful of compounding pharmacies in Arkansas and doctors say they're helping treat their patients even if it is slightly unconventional.
"I would have never even considered using a compounding pharmacy previous to this drug shortage and now essentially everyone I know is using compounding pharmacies to make their anesthetic drugs."

Video and article can be found here.