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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
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
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
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 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
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 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
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
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 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
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