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

[Missouriwatcher]

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

 

[Missouriwatcher]

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