Announcement

Collapse
No announcement yet.

Expanded Recall: All Clinical Specialties Sterile Products Including Avastin -- Cannot Guarantee Sterility

Collapse
X
 
  • Filter
  • Time
  • Show
Clear All
new posts

  • Expanded Recall: All Clinical Specialties Sterile Products Including Avastin -- Cannot Guarantee Sterility

    March 18 , 2013 - Clinical Specialties is voluntarily recalling Avastin unit dose syringes.

    The product has or potentially could result in an infection within the eye. Clinical Specialties has received reports of five intra-ocular infections from physician?s office and this is how the problem was identified.

    This product was being used solely as an off label use by an ophthalmologist for macular degeneration and is packaged in sterile syringes. The affected product name lots are as follows:
    Lot Number Exp. Date Lot Number Exp. Date
    CABDAHAC:39 5/8/2013 CABDACAB:56 4/2/2013
    CABDAGAC:58 4/13/2013 CABDACAB:76 4/2/2013
    CABDAHAC:77 4/8/2013 CABDACAB:89 4/2/2013
    CABDBIAC:86 4/19/2013 CABDADAB:69 4/3/2013
    CABDCFAC:29 4/26/2013 CABDADAB:93 4/3/2013
    CABDAEAD:26 5/3/2013 CABDADAB:54 4/3/2013
    CABDAEAC:47 5/5/2013 CABDAEAB:96 4/4/2013
    CABDAEAC:58 5/5/2013 CABDAHAB:00 4/7/2013
    CABDAFAC:46 5/6/2013 CABDAHAB:59 4/7/2013
    CABDAIAC:46 5/9/2013 CABDAHAB:18 4/7/2013
    CABDBCAC:94 5/13/2013 CABDAJAB:30 4/9/2013
    CABDCCAC:26 5/23/2013 CABDAJAB:70 4/9/2013
    CABDCFAC:81 5/26/2013 CABDAJAB:97 4/9/2013
    CABDABAD:05 5/30/2013 CABDBAAB:63 4/10/2013
    CABDAFAC:47 5/6/2013 CABDBAAB:77 4/10/2013
    CABDAGAC:43 5/7/2013 CABDBAAB:54 4/10/2013
    CABDBDAC:69 5/14/2013 CABDBAAB:04 4/10/2013
    CABDBIAC:77 5/19/2013 CABDBEAB:97 4/14/2013
    CABDCHAC:19 5/28/2013 CABDBFAB:67 3/16/2013
    CABDAHAD:21 6/5/2013 CABDBFAB:61 4/15/2013
    CABDCFAC:17 5/26/2013 CABDBFAB:84 4/15/2013
    CABDAHAD:00 6/5/2013 CABDBGAB:34 4/16/2013
    CABDBCAC:47 5/13/2013 CABDBHAB:33 4/17/2013
    CABDCBAC:97 5/22/2013 CABDBHAB:71 4/17/2013
    CABDAGAC:08 5/7/2013 CABDBHAB:75 4/17/2013
    CABDBCAC:15 5/13/2013 CABDCBAB:66 4/21/2013
    CABDBDAC:17 5/14/2013 CABDCCAB:64 4/22/2013
    CABDCIAC:42 5/29/2013 CABDCDAB:38 4/23/2013
    CABDBEAC:44 5/15/2013 CABDCEAB:71 4/24/2013
    CABDCBAC:79 5/22/2013 CABDCEAB:04 4/24/2013
    CABDCIAC:00 5/29/2013 CABDCFAB:22 3/26/2013
    CABDAHAD:82 6/5/2013 CABDCFAB:14 4/25/2013
    CABDCBAC:31 5/22/2013 CABDCIAB:51 4/28/2013
    CABDCIAB:68 4/28/2013 CABDCIAB:93 3/29/2013
    CABDCJAB:59 4/29/2013 CABDDBAB:71 4/1/2013
    CABDDBAB:93 5/1/2013 CABCBJBC:00 3/19/2013
    CABCCGBC:92 2/24/2013 CABCCGBC:30 3/26/2013
    CABCCGBC:49 3/26/2013 CABCCHBC:55 3/27/2013
    CABCCIBC:39 3/23/2013 CABCDBBC:87 3/31/2013
    CABCDBBC:71 3/1/2013

    This product would be administered by a licensed physician in a surgery or physician?s office setting. The syringes were distributed to doctors? offices in Georgia, Louisiana, South Carolina, and Indiana from December 18, 2012 to present.

    Clinical Specialties has notified the physician? offices by telephone. Doctors that have product which is being recalled should stop using the Avastin immediately.

    Consumers with questions regarding this recall may contact Clinical Specialties by phone at 866.880.1915 or e-mail address at clinicalrx@bellsouth.net ; Monday through Friday between the hours of 10 am to 5 pm EST. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

    Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
    http://www.fda.gov/Safety/Recalls/ucm344377.htm

  • #2
    Re: Expanded Recall: All Clinical Specialties Sterile Products Including Avastin -- Cannot Guarantee Sterility

    March 20, 2013 ? Clinical Specialties is voluntarily recalling All Lots of All Sterile products repackaged and distributed by the pharmacy due to lack of sterility assurance. The recall of all sterile products is conducted in follow-up to concerns regarding practices at the site which cannot assure the sterility of the products. The expanded recall follows the firm?s initial recall of Avastin due to reports of five patients who have been diagnosed with serious eye infections associated with the use of the product. Although there has been no evidence of contamination with sterile products other than the specified Avastin lots, Clinical Specialties has decided in the interest of their patients to proceed with this recall process.

    The Center for Disease Control and Prevention (CDC) notified the FDA of these endophthalmitis infections, which occur inside the eyeball. Endophthalmitis after intravitreal injection is a serious complication that can lead to permanent loss of vision. Clinical Specialties Compounding repackaged the Avastin into individual single-use syringes from the manufactured vials labeled as sterile.

    A compromised sterile product puts patients at risk for serious and possible life threatening infection.

    Clinical Specialties Compounding sterile products covered under this recall were distributed nationwide between October 19, 2012 and March 19, 2013. Until further notice, health care providers should stop using all sterile products distributed by Clinical Specialties Compounding and return them to the company...

    All Sterile Products
    Sterile preparation lot number Exp date
    Acetylcysteine 10 % solution CABCAFBA:73 9/30/2013
    Acetylcysteine 20 % solution CABCAJBA:76 10/4/2013
    Acetylcysteine 2 % solution CABDBDAC:98 8/12/2013
    Amphotericn 0.15% Ophthalmic CABCDABB:54 12/7/2012
    Amphotericn 5 mg/ml Ophthalmic CABADABB:68 12/14/2012
    BAM 144341 Study Drug solution CABCADBA:25 11/20/2012
    Cataract drops
    CABDAEAC:07 5/5/2013
    CABCCIBC:44 3/28/2013
    CABCAIBA:45 2/19/2013
    CABCCCBBB:74 1/6/2013
    Cyclosporine 1% ophthalmic drops
    CABCBEBB:35 5/13/2013
    CABACAB:76 7/1/2013
    CABCBCBB:65 2/10/2013
    CABDAIAB:78 4/8/2013
    CABDAEAC:80 5/5/2013
    CABDCCAC:31 5/23/2013
    Cyclosporine 2% ophthalmic drops
    CABCCIBC:89 3/28/2013
    CABDBEAB:07 4/14/2013
    CABDCIAB:42 4/28/2013
    CABDCCAC:37 5/23/2013
    Dexamethasone NaPo4 12 mg/ml CABCCEBA:85 2/21/2013
    Diazepam 5 mg/ml
    CABCCGAJ:04 12/25/2012
    CABCBJBA:65 1/17/2013
    CABCBABC:88 3/10/2013
    CABDBGAB:84 4/16/2013
    CABDAIAC:45 5/9/2013
    Estradiol Cypionate 5 mg/ml
    CABCACBA:20 3/31/2013
    CABCABBB:22 4/30/2013
    CABCBJBB:25 5/18/2013
    CABDAFAC:79 8/4/2013
    Estradiol Valerate 20 mg/ml
    CABCADBA:96 4/1/2013
    CABCAIBA:31 4/6/2013
    Estradiol Valerate 30 mg/ml
    CABCBFBB:12 5/14/2013
    CABDAIAD:28 9/4/2013
    Gentamicin buffered 36.4 mg/ml
    CABCAFBB:81 5/4/2013
    CABCCEAJ:85 3/23/2013
    CABDCFAC:25 8/24/2013
    HCG 1000 units/ml CABDAHAD:04 5/6/2013
    HCG 2000 units/ml
    CABDAJAB:54 3/10/2013
    CABDABAC:38 5/31/2013
    HCG 500 units/ml CABDBDAC:06 4/14/2013
    Hydroxyprogesterone 250 mg/ml
    CABCCBAJ:33 12/20/2012
    CABCBGBB:54 2/14/2013
    CABDAIAB:64 4/8/2013
    CABDAEAB:21 4/4/2013
    CABDBIAB:75 4/18/2013
    CABDAEAC:00 5/5/2013
    CABDJAC:67 5/20/2013
    Injection vehicle CABCCHBB:59 5/26/2013
    Itraconazole 1% eye ointment
    CABDCBAC:71 3/23/2013
    CABDCGAC:35 3/28/2013
    Laser ophthalmic drops
    CABCCBAJ:06 12/20/2012
    CABCCJBA:97 1/27/2013
    CABCCBBB:16 2/19/2013
    CABCCIBC:20 3/28/2013
    CABDAEAC:90 5/5/2013
    Latanoprost 0.025% eye drop
    CABCCCBA:52 12/21/2012
    CABCABBB:29 12/31/2012
    CABCCJBA:12 12/28/2012
    CABCCABC:32 2/18/2013
    CABCBHBC:13 2/15/2013
    CABDAEAB:70 3/5/2013
    CABDAFAD:09 5/4/2013
    CABCABBA:23 11/30/2012
    CABCACBB:64 1/1/2013
    CABCBDBB:44 1/12/2013
    CABCCIBB:36 1/27/2013
    CABCCGBC:76 2/24/2013
    CABDBHAH:10 3/18/2013
    CABDBGAB:27 3/17/2013
    medroxyprogesterone 150 mg/ml
    CABDDBAB:21 7/30/2013
    CABCBBBA:65 4/9/2013
    CABCBBBA:77 4/9/2013
    CABCBBBA:20 4/9/2013
    CABCCFBA:42 4/23/2013
    CABCCFBA:59 4/23/2013
    CABCCFBA:76 4/23/2013
    CABCCFBA:85 4/23/2013
    CABCCHBB:28 5/23/2013
    CABCCHBB:46 5/23/2013
    CABCCHBB:87 5/26/2013
    CABCCHBB:30 5/26/2013
    CABCBJBC:92 6/17/2013
    CABCBJBC:93 6/17/2013
    CABCBJBC:31 6/17/2013
    CABDAIAC:21 8/7/2013
    CABDDBAB:05 7/30/2013
    CABDDBAB:03 7/30/2013
    CABDDBAB:43 7/30/2013
    CABDAIAC:45 8/7/2013
    CABDAIAC:13 8/7/2013
    Medroxyprogesterone 50 mg/ml
    CABCADBA:18 1/1/2013
    CABDABAC:01 5/2/2013
    Methionine/Choline/Inositol/ B-12
    CABCCBAJ:32 12/20/2012
    CABCCJBA:97 1/27/2013
    CABCBCBC:64 3/12/2013
    CABDAHAB:35 4/7/2013
    CABDBIAC:77 5/19/2013
    Methylcobalamin 1250 mcg/ml
    CABCACBA:49 11/1/2012
    CABCDBBA:19 11/30/2012
    CABCCIBB:04 12/28/2012
    CABCCBBC:37 1/20/2013
    CABCEAB:31 2/23/2013
    CABDCGAC:49 3/28/2013
    Methylcobalamin 12.5 mg/ml
    CABCBJBA:55 4/17/2013
    CABDCCAB:52 7/21/2013
    CABDCGAC:50 8/25/2013
    Mitomycin 0.02% solution
    CABCAIBA:94 1/6/2013
    CABCDBBA:75 12/15/2012
    CABCBCBC:22 1/26/2013
    CABDCCAB:56 3/8/2013
    CABDCIAB:51 3/14/2013
    Mitomycin 0.04% solution
    CABCCJBA:70 12/13/2012
    CABDCBAB:57 3/7/2013
    CABDAGAD:25 4/20/2013
    CABDAGAD:84 4/20/2013
    Mitomycin (modified) 0.02% solution
    CABDAGAD:68 4/20/2013
    CABDAGAD:60 4/20/2013
    ophthalmic dilation gel
    CABDBDAC:11 8/12/2013
    CABCCHAJ:28 3/26/2013
    CABCBBBA:57 4/9/2013
    CABCCGBA:11 4/24/2013
    CABCACBB:26 5/1/2013
    CABCBGBB:54 5/15/2013
    CABCCJBB:38 5/28/2013
    CABCBDBC:40 6/11/2013
    CABCCIBC:73 6/26/2013
    CABDBBAB:32 7/10/2013
    CABDCEAB:92 7/23/2013
    CABDAHAC:76 8/6/2013
    CABDCBAC:11 8/20/2013
    CABDAHAD:85 9/3/2013
    Ophthalmic gel (eps) CABCDABA:89 1/28/2013
    Ophthalmic dilation gel (MAR)
    CABDBFAC:88 5/16/2013
    CABCCCBA:79 1/20/2013
    CABCBDBB:41 2/11/2013
    CABCBIBC:55 3/18/2013
    CABDCBAB:42 4/21/2013
    pap 300 mg-phent 10 mg-prost 100 mcg
    CABDBFAC:52 5/16/2013
    CABCCEBA:19 1/22/2013
    CABCBDBB:78 2/11/2013
    CABCAHBC:88 3/7/2013
    CABDBBAB:40 4/11/2013
    CABDCAAC:15 5/21/2013
    CABDCCAC:75 5/23/2013
    CABDAFAD:77 6/3/2013
    papav 150 mg-prost 50 mcg CABCBJBC:84 3/19/2013
    Papav 30 mg-phentol 1 mg/ml CABCBBBA:91 1/9/2013
    Phenylephrine-cyclopentolate CABDBIAB:14 7/17/2013
    Progesterone 50 mg/ml
    CABDBFAC:48 5/17/2014
    CABCBHBC:77 3/18/2014
    CABDCEAB:14 4/25/2014
    Sodium Chloride (23.4%)
    CABCCEAJ:09 3/23/2013
    CABCBFBA:92 4/13/2013
    CABDAGAC:58 8/5/2013
    CABDAEAD:01 8/31/2013
    Tacroimus 0.03% ophthalmic gel
    CABCBFBB:97 12/15/2012
    CABCCBBC:17 1/20/2013
    CABDAEAB:17 2/3/2013
    Tacrolimus 5 mg/ml solution CABCCJBB:15 12/29/2012
    Test Cyp 10 mg/ml CABCAFBC:17 6/3/2013
    Test Cyp 100 mg/ml
    CABCBFBA:15 4/13/2013
    CABCACBA:58 3/31/2013
    CABCAHBB:54 5/6/2013
    CABCCHBB:63 5/26/2013
    CABCAFBC:31 6/3/2013
    CABCCHBS:23 6/25/2013
    CABDBAAB:64 7/9/2013
    CABDAIAB:59 7/7/2013
    CABDAFAC:48 8/4/2013
    CABDBJAC:27 8/18/2013
    CABDABAD:61 8/28/2013
    Test Cyp 200 mg/ml
    CABCBJBA:26 4/17/2013
    CABCBEBB:55 5/13/2013
    CABCBEBB:75 5/13/2013
    CABCCBBC:96 6/19/2013
    CABCCHBC:80 6/25/2013
    CABDAJAB:88 7/8/2013
    CABDAEAB:41 7/3/2013
    CABDBBAB:23 7/10/2013
    CABDBHAB:14 7/16/2013
    CABDCEAB:13 7/23/2013
    CABDCFAB:33 7/24/2013
    CABDABAD:38 8/28/2013
    Test cyp 25 mg-Estadiol valerate 15 mg CABCBJBC:70 6/17/2013
    Test cyp 25 mg-Estradiol cyp 5 mg/ml CABDBHAB:54 7/16/2013
    Test Cyp 250 mg-lidocaine 5 mg/ml
    CABCCABB:74 5/19/2013
    CABCCABB:31 7/29/2013
    Test cyp 25 mg-estradiol cyp 7 mg/ml CABCAFBC:67 6/3/2013
    Test Cyp 25 mg-e(2) blend 12 mg/ml CABCCHBB:03 5/26/2013
    Test cyp 35 mg/ml CABDCAAC:13 8/19/2013
    Test cyp 50 mg/ml CABCCHBB:81 5/26/2013
    Test Cyp 50 mg-estradiol cyp 2 mg/ml
    CABCACBB:31 10/28/2013
    CABDBGAB:74 1/11/2014
    Test Cyp 50 mg-estradiol cyp 5 mg/ml
    CABCACBA:23 3/31/2013
    CABDAIAD:13 9/4/2013
    Test Cyp 50 mg-estradiol cyp 7 mg/ml CABCACBA:16 10/2/2013
    Test Cyp 50 mg-estradiol blend 22 mg
    CABCAIBA:36 4/6/2013
    CABDDAAB:10 7/29/2013
    CABDAIAD:01 9/4/2013
    Test cyp 75 mg-estradiol cyp 5 mg/ml CABCAIBB:44 5/7/2013
    Tetracaine 2% injectable
    CABCCDBA:60 11/22/2012
    CABCBABC:74 1/9/2013
    CABDCCAB:70 2/21/2013
    Tetracaine(buffered) 0.25% solution
    CABCBABA:13 1/8/2013
    CABCBDBB:25 2/11/2013
    CABCAHBB:93 2/5/2013
    CABCBCBC:87 3/12/2013
    CABDCCAB:46 4/22/2013
    CABDAGAC:58 5/7/2013
    CABDAGAD:07 6/4/2013
    Vancomycin 14 mg/ml CABCBBBA:17 11/10/2012
    vancomycin 50 mg/ml
    CABDBEAB:92 2/13/2013
    CABDAGAC:43 3/8/2013
    CABDCCAC:54 3/24/2013
    vancomycin 100 mg/ml
    CABCBBBA:37 10/25/2012
    CABDBEAB:05 1/28/2013
    CABDCCAC:16 3/8/2013
    http://www.fda.gov/Safety/Recalls/ucm344786.htm

    Comment

    Working...
    X