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U.S. Department of Health and Human Services

Enforcement Report - Week of July 10, 2013

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Event Detail

Event ID 64661
Product Type Drugs
Status Ongoing
Recalling Firm Clinical Specialties Compounding Pharmacy
City Augusta
State GA
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-03-20
Initial Firm Notification of
Consignee or Public
Telephone
Distribution Pattern FL, GA and SC.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Vancomycin 50 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907 Lot number CABDCCAC:54, Exp date: 3/24/2013. Class II Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes 20ml total D-680-2013
Tetracaine(buffered) 0.25% solution, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907 Lot number CABDCCAB:46, Exp date: 4/22/2013; Lot number CABDAGAC:58, Exp date: 5/7/2013 and Lot number CABDAGAD:07 Exp date: 6/4/2013. Class II Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes 474ml total D-679-2013
Test cyp 75 mg-estradiol cyp 5 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907 Lot number CABCAIBB:44, Exp date: 5/7/2013. Class II Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes 11ml D-678-2013
Test Cyp 50 mg-estradiol blend 22 mg, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907 Lot number CABCAIBA:36, Exp date: 4/6/2013; Lot number CABDDAAB:10, Exp date: 7/29/2013 and Lot number CABDAIAD:01 Exp date: 9/4/2013. Class II Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes 13ml total D-677-2013
Test Cyp 50 mg-estradiol cyp 7 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907 Lot number CABCACBA:16, Exp date: 10/2/2013. Class II Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes 3ml D-676-2013
Test Cyp 50 mg-estradiol cyp 2 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907 Lot number CABCACBA:23, Exp date: 3/31/2013 and Lot number CABDAIAD:13, Exp date: 9/4/2013. Class II Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes 13ml D-675-2013
Test Cyp 50 mg-estradiol cyp 2 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907 Lot number CABCACBB:31, Exp date: 10/28/2013 and Lot number CABDBGAB:74, Exp date: 1/11/2014. Class II Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes 65ml total D-674-2013
Test cyp 50 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907 Lot number CABCCHBB:81, Exp date: 5/26/2013. Class II Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes 12ml D-673-2013
Pap 300 mg-phent 10 mg-prost 100 mcg, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907 Lot number CABDBFAC:52, Exp date: 5/16/2013; Lot number CABDBBAB:40, Exp date: 4/11/2013; Lot number CABDCAAC:15, Exp date: 5/21/2013; Lot number CABDCCAC:75, Exp date: 5/23/2013 and Lot number CABDAFAD:77, Exp date: 6/3/2013. Class II Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes 96ml total D-660-2013
Ophthalmic dilation gel (MAR), Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907 Lot number CABDBFAC:88, Exp date: 5/16/2013; and Lot number CABDCBAB:42, Exp date: 4/21/2013. Class II Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes 360ml total D-659-2013
Ophthalmic dilation gel, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907 Lot number CABDBDAC:11, Exp date: 8/12/2013; Lot number CABCCHAJ:28, Exp date: 3/26/2013; Lot number CABCBBBA:57, Exp date: 4/9/2013; Lot number CABCCGBA:11, Exp date: 4/24/2013; Lot number CABCACBB:26, Exp date: 5/1/2013; Lot number CABCBGBB:54, Exp date: 5/15/2013; Lot number CABCCJBB:38, Exp date: 5/28/2013; Lot number CABCBDBC:40, Exp date: 6/11/2013; Lot number CABCCIBC:73, Exp date: 6/26/2013; Lot number CABDBBAB:32, Exp date: 7/10/2013; Lot number CABDCEAB:92, Exp date: 7/23/2013; Lot number CABDAHAC:76, Exp date: 8/6/2013; Lot number CABDCBAC:11, Exp date: 8/20/2013 and Lot number CABDAHAD:85, Exp date: 9/3/2013. Class II Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes 378ml total D-658-2013
Mitomycin (modified) 0.02% solution, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907 Lot number CABDAGAD:68 , Exp date: 4/20/2013 and Lot number CABDAGAD:60, Exp date: 4/20/2013. Class II Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes 6ml total D-657-2013
Mitomycin 0.04% solution, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907 Lot number CABDAGAD:25, Exp date: 4/20/2013 and Lot number CABDAGAD:84, Exp date: 4/20/2013. Class II Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes 50ml total D-656-2013
Methylcobalamin 12.5 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907 Lot number CABCBJBA:55, Exp date: 4/17/2013; Exp date: Lot number CABDCCAB:52, Exp date: 7/21/2013 and Lot number CABDCGAC:50, Exp date: 8/25/2013. Class II Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes 95ml total D-655-2013
Methylcobalamin 1250 mcg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907 Lot number CABDCGAC:49, Exp date: 3/28/2013. Class II Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes 36ml D-654-2013
Methionine/Choline/Inositol/ B-12, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907 Lot number CABDAHAB:35, Exp date: 4/7/2013 and Lot number CABDBIAC:77, Exp date: 5/19/2013. Class II Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes 255ml total D-653-2013
Medroxyprogesterone 50 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907 Lot number CABDABAC:01, Exp date: 5/2/2013. Class II Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes 2ml total D-652-2013
Medroxyprogesterone 150 mg/ml,Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907 Lot number CABDDBAB:21, Exp date: 7/30/2013; Lot number CABCBBBA:65, Exp date: 4/9/2013; Lot number CABCBBBA:77, Exp date: 4/9/2013; Lot number CABCBBBA:20 , Exp date: 4/9/2013; Lot number CABCCFBA:42, Exp date: 4/23/2013; Lot number CABCCFBA:59, Exp date: 4/23/2013; Lot number CABCCFBA:76, Exp date: 4/23/2013; Lot number CABCCFBA:85, Exp date: 4/23/2013; Lot number CABCCHBB:28, Exp date: 5/23/2013; Lot number CABCCHBB:46, Exp date: 5/23/2013; Lot number CABCCHBB:87, Exp date: 5/26/2013; Lot number CABCCHBB:30, Exp date: 5/26/2013; Lot number CABCBJBC:92, Exp date: 6/17/2013; Lot number CABCBJBC:93, Exp date: 6/17/2013; Lot number CABCBJBC:31, Exp date: 6/17/2013; Lot number CABDAIAC:21, Exp date: 8/7/2013; Lot number CABDDBAB:05, Exp date: 7/30/2013; Lot number CABDDBAB:03, Exp date: 7/30/2013; Lot numberCABDDBAB:43, Exp date: 7/30/2013; Lot number CABDAIAC:45, Exp date: 8/7/2013 and Lot number CABDAIAC:13, Exp date: 8/7/2013. Class II Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes 220ml total D-651-2013
Test cyp 35 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907 Lot number CABDCAAC:13, Exp date: 8/19/2013. Class II Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes 12ml D-672-2013
Test Cyp 25 mg-e(2) blend 12 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907 Lot number CABCCHBB:03, Exp date: 5/26/2013. Class II Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes 8ml D-671-2013
Test cyp 25 mg-estradiol cyp 7 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907 Lot number CABCAFBC:67, Exp date: 6/3/2013. Class II Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes 12ml D-670-2013
Test Cyp 250 mg-lidocaine 5 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907 Lot number CABCCABB:74, Exp date: 5/19/2013 and Lot number CABCCABB:31 Exp date: 7/29/2013. Class II Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes 10ml total D-669-2013
Test cyp 25 mg-Estradiol cyp 5 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907 Lot number CABDBHAB:54, Exp date: 7/16/2013 Class II Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes 4ml D-668-2013
Test cyp 25 mg-Estadiol valerate 15 mg/mL, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907 Lot number CABCBJBC:70, Exp date: 6/17/2013 Class II Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes 7ml D-667-2013
Test Cyp 200 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907 Lot number CABCBJBA:26, Exp date: 4/17/2013; Lot number CABCBEBB:55, Exp date: 5/13/2013; Lot number CABCBEBB:75, Exp date: 5/13/2013; Lot number CABCCBBC:96, Exp date: 6/19/2013; Lot number CABCCHBC:80, Exp date: 6/25/2013; Lot number CABDAJAB:88, Exp date: 7/8/2013; Lot number CABDAEAB:41, Exp date: 7/3/2013; Lot number CABDBBAB:23, Exp date: 7/10/2013; Lot number CABDBHAB:14, Exp date: 7/16/2013; Lot number CABDCEAB:13, Exp date: 7/23/2013; Lot number CABDCFAB:33, Exp date: 7/24/2013 and Lot number CABDABAD:38, Exp date: 8/28/2013. Class II Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes unknown D-666-2013
Test Cyp 100 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907 Lot number CABCBFBA:15, Exp date: 4/13/2013; Lot number CABCACBA:58, Exp date: 3/31/2013; Lot number CABCAHBB:54, Exp date: 5/6/2013; Lot number CABCCHBB:63, Exp date: 5/26/2013; Lot number CABCAFBC:31, Exp date: 6/3/2013; Lot number CABCCHBS:23, Exp date: 6/25/2013; Lot number CABDBAAB:64, Exp date: 7/9/2013; Lot number CABDAIAB:59, Exp date: 7/7/2013; Lot number CABDAFAC:48, Exp date: 8/4/2013; Lot number CABDBJAC:27, Exp date: 8/18/2013 and Lot number CABDABAD:61, Exp date: 8/28/2013. Class II Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes 219ml total D-665-2013
Test Cyp 10 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907 Lot number CABCAFBC:17, Exp date: 6/3/2013. Class II Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes 7ml D-664-2013
Sodium Chloride (23.4%), Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907 Lot number CABCCEAJ:09, Exp date: 3/23/2013; Lot number CABCBFBA:92, Exp date: 4/13/2013; Lot number CABDAGAC:58, Exp date: 8/5/2013 and Lot number CABDAEAD:01, Exp date: 8/31/2013. Class II Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes 116ml total D-663-2013
Progesterone 50 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907 Lot number CABDBFAC:48, Exp date: 5/17/2014; and Lot number CABDCEAB:14, Exp date: 4/25/2014. Class II Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes 637ml total D-662-2013
Phenylephrine-cyclopentolate, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907 Lot number CABDBIAB:14, Exp date: 7/17/2013. Class II Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes 60ml D-661-2013
Latanoprost 0.025% eye drop, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907 Lot number CABDAFAD:09, Exp date: 5/4/2013 Class II Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes 70ml total D-650-2013
Laser ophthalmic drops, 12 mL bottle, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907 Lot number CABCCIBC:20, Exp date: 3/28/2013 and Lot number CABDAEAC:90, Exp date: 3/5/2013. Class II Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes D-649-2013
Itraconazole 1% eye ointment, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907 Lot number CABDCBAC:71, Exp date: 3/23/2013 and Lot number CABDCGAC:35, Exp date: 3/28/2013. Class II Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes 10ml total D-648-2013
Injection vehicle, 120 ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907 Lot number CABCCHBB:59, Exp date: 5/26/2013. Class II Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes D-647-2013
Hydroxyprogesterone 250 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907 Lot number CABDAIAB:64, Exp date: 4/8/2013; Lot number CABDAEAB:21, Exp date: 4/4/2013; Lot number CABDBIAB:75, Exp date: 4/18/2013; Lot number CABDAEAC:00, Exp date: 5/5/2013 and Lot number CABDJAC:67, Exp date: 5/20/2013. Class II Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes D-646-2013
HCG 500 units/ml, 10 mL syringe, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907 Lot number CABDBDAC:06, Exp date: 4/14/2013. Class II Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes D-645-2013
HCG 2000 units/ml, 30 mL syringe, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907 Lot number CABDAJAB:54, Exp date: 3/10/2013 and Lot number CABDABAC:38, Exp date: 5/31/2013. Class II Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes D-644-2013
HCG 1000 units/ml, 30 mL syringe, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907 Lot number CABDAHAD:04 Exp date: 5/6/2013. Class II Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes D-643-2013
Gentamicin buffered 36.4 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907 Lot number CABCAFBB:81, Exp date: 5/4/2013; Lot number CABCCEAJ:85 Exp date: 3/23/2013 and Lot number CABDCFAC:25 Exp date: 8/24/2013. Class II Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes 35ml total D-642-2013
Estradiol Valerate 30 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907 Lot number CABCBFBB:12, Exp date: 5/14/2013 and Lot number CABDAIAD:28, Exp date: 9/4/2013. Class II Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes 18ml total D-641-2013
Estradiol Valerate 20 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907 Lot number CABCADBA:96, Exp date: 4/1/2013 and Lot number CABCAIBA:31, Exp date: 4/6/2013. Class II Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes 17ml total D-640-2013
Estradiol Cypionate 5 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907 Lot number CABCACBA:20, Exp date: 3/31/2013; Lot number CABCABBB:22, Exp date: 4/30/2013; Lot number CABCBJBB:25, Exp date: 5/18/2013 and Lot number CABDAFAC:79, Exp date: 8/4/2013. Class II Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. 95 ml total D-639-2013
Diazepam 5 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907 Lot number CABDBGAB:84, Exp date: 4/16/2013 and Lot number CABDAIAC:45, Exp date: 5/9/2013. Class II Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. 222 ml total D-638-2013
Cyclosporine 2% ophthalmic, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907 Lot number CABCCIBC:89, Exp date: 3/28/2013; Lot number CABDBEAB:07, Exp date: 4/14/2013; Lot number CABDCIAB:42, Exp date: 4/28/2013 and Lot number CABDCCAC:37, Exp date: 5/23/2013. Class II Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. 87 ml total D-637-2013
Cyclosporine 1% ophthalmic drops, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907 Lot number CABCBEBB:35, Exp date: 5/13/2013; Lot number CABACAB:76 Exp date: 7/1/2013; Lot number CABDAIAB:78, Exp date: 4/8/2013; Lot number CABDAEAC:80, Exp date: 5/5/2013 and Lot number CABDCCAC:31, Exp date: 5/23/2013. Class II Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. 55 ml D-636-2013
Cataract drops, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907 Lot number CABDAEAC:07, Exp date: 5/5/2013; Lot number CABCCIBC:44, Exp date: 3/28/2013 Class II Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. 80 ml total D-635-2013
Acetylcysteine 2 % Solution, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907 Lot number CABDBDAC:98, Exp date: 8/12/2013 Class II Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. 10ml D-634-2013
Acetylcysteine 20 % solution, 100 ml bottle, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907 Lot number CABCAJBA:76, Exp date: 10/4/2013 Class II Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. D-633-2013
Acetylcysteine 10 % Solution, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907 Lot number CABCAFBA:73, Exp date: 9/30/2013 Class II Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes 300ml D-632-2013
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