Progesterone 50 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907

FDA recall notice · announced July 10, 2013 · Clinical Specialties Compounding Pharmacy

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The product

Reason for recall

Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes

Notes

Distribution: FL, GA and SC.
Lot/code information: Lot number CABDBFAC:48, Exp date: 5/17/2014; and Lot number CABDCEAB:14, Exp date: 4/25/2014.
Quantity: 637ml total
Status: Terminated
Products in this recall event:
- Test Cyp 50 mg-estradiol blend 22 mg, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907 (D-677-2013)
- Methylcobalamin 12.5 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907 (D-655-2013)
- Vancomycin 50 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907 (D-680-2013)
- Injection vehicle, 120 ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907 (D-647-2013)
- Methylcobalamin 1250 mcg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907 (D-654-2013)
- Ophthalmic dilation gel (MAR), Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907 (D-659-2013)
- Mitomycin 0.04% solution, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907 (D-656-2013)
- Phenylephrine-cyclopentolate, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907 (D-661-2013)
- Sodium Chloride (23.4%), Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907 (D-663-2013)
- Ophthalmic dilation gel, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907 (D-658-2013)
- Mitomycin (modified) 0.02% solution, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907 (D-657-2013)
- Medroxyprogesterone 50 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907 (D-652-2013)
- Estradiol Valerate 20 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907 (D-640-2013)
- Test Cyp 25 mg-e(2) blend 12 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907 (D-671-2013)
- Test Cyp 50 mg-estradiol cyp 7 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907 (D-676-2013)
- Tetracaine(buffered) 0.25% solution, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907 (D-679-2013)
- Acetylcysteine 2 % Solution, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907 (D-634-2013)
- Acetylcysteine 10 % Solution, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907 (D-632-2013)
- Gentamicin buffered 36.4 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907 (D-642-2013)
- Diazepam 5 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907 (D-638-2013)
- Medroxyprogesterone 150 mg/ml,Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907 (D-651-2013)
- Methionine/Choline/Inositol/ B-12, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907 (D-653-2013)
- Latanoprost 0.025% eye drop, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907 (D-650-2013)
- Estradiol Valerate 30 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907 (D-641-2013)
- Estradiol Cypionate 5 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907 (D-639-2013)
- Hydroxyprogesterone 250 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907 (D-646-2013)
- Pap 300 mg-phent 10 mg-prost 100 mcg, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907 (D-660-2013)
- Acetylcysteine 20 % solution, 100 ml bottle, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907 (D-633-2013)
- Test cyp 25 mg-estradiol cyp 7 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907 (D-670-2013)
- Test Cyp 10 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907 (D-664-2013)
- Test Cyp 100 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907 (D-665-2013)
- Test Cyp 200 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907 (D-666-2013)
- Laser ophthalmic drops, 12 mL bottle, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907 (D-649-2013)
- Cataract drops, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907 (D-635-2013)
- Cyclosporine 2% ophthalmic, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907 (D-637-2013)
- Test cyp 25 mg-Estadiol valerate 15 mg/mL, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907 (D-667-2013)
- Test cyp 75 mg-estradiol cyp 5 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907 (D-678-2013)
- Cyclosporine 1% ophthalmic drops, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907 (D-636-2013)
- HCG 1000 units/ml, 30 mL syringe, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907 (D-643-2013)
- Test cyp 50 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907 (D-673-2013)
- HCG 500 units/ml, 10 mL syringe, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907 (D-645-2013)
- Test cyp 25 mg-Estradiol cyp 5 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907 (D-668-2013)
- Test Cyp 50 mg-estradiol cyp 2 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907 (D-674-2013)
- Test Cyp 250 mg-lidocaine 5 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907 (D-669-2013)
- Itraconazole 1% eye ointment, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907 (D-648-2013)
- HCG 2000 units/ml, 30 mL syringe, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907 (D-644-2013)
- Test Cyp 50 mg-estradiol cyp 2 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907 (D-675-2013)
- Test cyp 35 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907 (D-672-2013)
- Progesterone 50 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907 (D-662-2013)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.