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Clinical Specialties Compounding Pharmacy Recalling All Lots of Sterile Products

Thu, 03/21/2013 - 8:22am

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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