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

Urgent: Franck's Compounded Prescription Recall

Urgent: Compounded Prescription Recall

Contact
Consumer:
352-690-6773

Media:
352-622-2913

FOR IMMEDIATE RELEASE - May 25, 2012 - This is to inform you of a product recall involving:

All Sterile Human and Veterinary Prescriptions Distributed by Franck’s Pharmacy From November 21, 2011 to May 21, 2012.

This recall is being initiated after the U.S. Food and Drug Administration ("FDA") notified us that environmental sampling of our clean room revealed the presence of microorganisms and fungal growth. In light of the FDA’s findings and the resulting possible risk of infection, we have decided that it is imperative that we recall all human and veterinary sterile preparations that have left our control. Accordingly, we are extending the recall to all sterile preparations we have provided to you since November 21, 2011.
If any of these sterile preparations remains under your control, it is essential that you do not use them and that employing appropriate practices, you destroy all such sterile preparations and all remaining portions of such sterile preparations.
This recall should be carried out to the User/Physician level. Your assistance is appreciated and necessary to prevent patient illness. Physicians should be advised to review and evaluate their patient records to determine if any adverse events may have resulted from use of the recalled products. Please report any adverse events to Franck’s Compounding Pharmacy and FDA’s MedWatch program.
FDA will expect us to be able to account for all of the sterile preparations subject to this recall. As a result, it is critically important that you read, complete, and return the enclosed response form as soon as possible.
We will update you with any relevant details as they become available to us. If you have any questions please call us at 352-690-6773, Monday through Friday from 9AM to 5 PM, EST.
This recall is being made with the knowledge of the Food and Drug Administration.

Franck's Compounding Lab: Notice of Recall - Triamcinolone acetonide P.F. 80mg/ml

These recalls relating to Franck's Compounding Lab were issued on March 31, 2012, and May 1, 2012

Recall -- Firm Press Release

FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.

Notice of Recall - Triamcinolone acetonide P.F. 80mg/ml

Contact:
Jim Kilbride, RPh
Pharmacist-in-Charge
Franck’s Compounding Lab
1210 SW 33rd Ave. Ocala, FL 34474
352-622-2913
Fax: 352-690-6770

May 2, 2012

Dear Physician,

Franck’s lab recently had a fungal issue with one lot of triamcinolone acetonide P.F. 80mg/ml and on March 29, 2011 instituted a recall. The recall involved five physicians and eight prescriptions. The physicians have been contacted and all prescriptions accounted. As a precaution Franck’s Lab has recalled one additional lot of triamcinolone acetonide P.F. 80mg/ml. No adverse events have been reported related to this lot. The recall involved four physicians and five prescriptions. All offices have been contacted. If you have any concerns or questions regarding a prescription of triamcinolone acetonide or product containing triamcinolone acetonide received from Franck’s do not hesitate to contact us.

Regards,
Jim Kilbride, RPh
Pharmacist-in-Charge
Franck’s Compounding Lab
1210 SW 33rd Ave. Ocala, FL 34474
352-622-2913
Fax: 352-690-6770

Recall -- Firm Press Release

FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.

NOTICE OF RECALL

Contact:
Jim Kilbride, RPh
Pharmacist-in-Charge
Franck’s Compounding Lab
1210 SW 33rd Ave. Ocala, FL 34474
352-622-2913
Fax: 352-690-6770

March 31, 2012

Dear Physician
Franck’s lab recently had a fungal issue with one lot of triamcinolone acetonide P.F. 80mg/ml and instituted a recall. The recall involved five physicians and seven prescriptions. The physicians have been contacted and all prescriptions accounted. If you have any concerns or questions regarding a prescription of triamcinolone acetonide or product containing triamcinolone acetonide received from Franck’s do not hesitate to contact us.

Regards,
Jim Kilbride, RPh
Pharmacist-in-Charge
Franck’s Compounding Lab
1210 SW 33rd Ave. Ocala, FL 34474
352-622-2913
Fax: 352-690-6770

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More on FDA's recall of Franck's Brilliant Blue G

More information regarding the FDA's recall of Brilliant Blue G-Dye can found in this news article entitled, Eye infections linked to Ocala's Franck's Compounding Lab.  Click here to read article.