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Reference Desk March 2013

Clinical Specialties Compounding Pharmacy Announces Voluntary Nationwide Recall

    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.

    Consumers or Health Care providers 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.  Patients who have received any product distributed by Clinical Specialties Compounding and have concerns should contact their healthcare provider.

    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.

    Regular Mail: use postage-paid, pre-addressed Form FDA 3500 available here. Mail to address on the pre-addressed form.

    Fax: 1-800-FDA-0178

    This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

     

    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

    Source: FDA

    didyouknow

    Did you know... At least two-thirds of pet owners in the US and Europe turn to their vet or vet assistant about their pet's health. The second most popular source is online with over half (59%) of all pet owners likely to go to websites for information. Read More

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