Food Recalls (FDA)

Clinical Specialties Compounding Pharmacy Announces Voluntary Nationwide Recall of All lots of Sterile Products Repackaged and Distributed by Clinical Specialties Compounding Due to Lack of Sterility Assurance

Published on Thursday, 21 March 2013 01:22

FG_AUTHORS: FDA

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.   Clinical Specialties Compounding Pharmacy Announces Voluntary Nationwide Recall of All lots of Sterile Products Repackaged and Distributed by Clinical Specialties Compounding Due to Lack of Sterility Assurance   Contact
Consumer:
866.880.1915
clinicalrx@bellsouth.net

Media:
Clinical Specialties
706-855-1915

FOR IMMEDIATE RELEASE – 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.

Online: www.fda.gov/medwatch/report.htm 

Regular Mail: use postage-paid, pre-addressed Form FDA 3500 available at: www.fda.gov/MedWatch/getforms.htm. 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

 

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