Compounding Pharmacy Issues Recall Human & Vetinary Medicine

Specialty Medicine Compounding Pharmacy is voluntarily recalling all lots of certain unexpired human and veterinary sterile products to the consumer level due to particulate matter found in vials of a compounded dextrose injection product dispensed to a local hospital. Further testing and analysis of the medication is being conducted.

Specialty Medicine Compounding Pharmacy has not received any reports of adverse events related to this recall. If there is microbial contamination in products intended to be sterile, patients are at risk for serious, potentially life-threatening infections.

The recalled products were distributed to hospitals and consumers located only within Michigan from July 1, 2013, through October 19, 2013.  No products were distributed out of state.

All unexpired lots of the following compounded products are subject to the recall:

Human Products
Acetylcysteine, 5%	Acetylcysteine, 10%	Acetylcysteine, 20%
Aluminum Potassium Sulfate	Aminophylline PF, 25mg/ml	Bevacizumab, 0.06ml (repackaged)
Bevacizumab, 0.11ml (repackaged)	Bi-Mix, 15mg/0.5mg	Biotin IM, 1mg/ml
Calcium Chloride PF, 500mg/ml	Ceftazidime, 22.5mg/ml (ophthalmic)	Clorpactin, 0.1%
Combo Eye Gel	Cyanocobalamin, 1000mcg/ml	Cyclopentolate HCL, 2% (ophthalmic)
Dexamethasone NaPO4  ionto-pf, 4mg/ml	Dextrose Vial, 50%	DMSO/Glutath, 3.75%/1.75% (ophthalmic)
Edetate Disodium (0.05m), 1.7%	Epinephrine (PF/SF), 0.5ml in 3ml	Epinephrine PF SF (0.3ml), 1:1000
Epinephrine PF SF (1ml), 1:1000	Fentanyl PF, 50mcg/ml	Fluconazole/Gentamicin, 200mg/480mg/1L
Fluorouracil PF, 50mg/ml	Gatifloxacin, 0.2ml 0.5% (ophthalmic) (repackaged)	Glutathione PF, 60mg/ml inhalation
Glycerin-Chromated (w/v), 72%	Hyaluronidase, pf 100U/ml	Hyaluronidase, pf 150U/ml
Hydroxocobalamin, 10,000mcg/ml	Hydroxocobalamin/thiamine, 1mg/100mg/ml	Lidocaine/Sodium Chloride, 0.4%/18%
Magnesium Sulfate, 1gm/50ml	Magnesium Sulfate, 2gm/50ml	Methocarbamol, 100mg/ml (repackaged)
Methylcobalamin, 1000mcg/ml	Methylcobalamin, 10mg/ml	Methylcobalamin, 25mg/ml
Methylcobalamin, 5000mcg/ml	Methylcobalamin, PF 25mg/ml	Multitrace-4 Pediatric Injection
Naloxone HCL, 0.4mg/ml	Naltrexone MCV, 1mg/ml	Neomycin, 333mg/ml
Papav/Phentol/PG E1, 30mg/1mg/20mcg/ml	Papaverine HCL, (10ml) 30mg/ml	Papaverine HCL, (2ml) 30mg/ml
Papaverine HCL, 30mg/ml	Phenol, 6%	Phenylephrine/Tropicamide, 2.5%/1% (ophthalmic)
Polidocanol, 1%	Polidocanol, 3%	Potassium Phosphate, 4.4meq/3mmol/ml
Proparacaine HCL PF, 0.5% (ophthalmic)	Quad Mix, 0.05mg/25mg/2mg/25mcg/ml	Quad Mix, 0.1mg/30mg/2mg/20mcg/ml
Quad Mix, 0.1mg/30mg/2mg/50mcg/ml	Quad Mix, 0.1mg/9mg/1mg/10mcg/ml	Quad Mix, in NaCl (1.8/0.2/0.02)mg/18mcg/ml
Sodium Chloride, 0.9% (repackaged)	Sodium Chloride, PF 14.6%	Sodium Phosphate, PF 3mmol/ml
Sodium tetradecyl SO4, 3%	Sodium Thiosulfate PF, 10%	Super Quad Mix, 0.1mg/30mg/2mg/20 mcg/ml
Testos Cypionate in Oil, 100mg/ml	Testos Cypionate in Oil, 200mg/ml	Testos Cypionate in Olive Oil, 200mg/ml
Tranexamic Acid, 2gm/100ml	Tranexamic Acid, 2gm/75ml	Triple Mix, 15mg/0.5mg/10mcg/ml
Triple Mix, 15mg/1mg/20mcg/ml	Triple Mix, 30mg/1mg/10mcg/ml	Triple Mix, 30mg/1mg/20mcg/ml
Triple Mix, 30mg/1mg/40mcg/ml	Tropicamide, 1%	Vancomycin HCL, 10 mg/ml (ophthalmic)
Vigamox in BSS (0.15%), 0.75mg/0.5ml
Veterinary Products
Amikacin Sulfate, 250mg/ml	Buprenorphine HCL, 0.3mg/ml	Buprenorphine HCL, 0.6mg/ml
Ceftazidime in pluronic 250mg/ml gel	Cyclosporin A Oint, 0.2% (ophthalmic)	Cyclosporin MCT, 0.2% (ophthalmic)
Cyclosporin MCT, 1% (ophthalmic)	Desmopressin Acetate (0.01%), 0.1mg/ml	Desmopressin Acetate (0.0125%), 0.125mg/ml
Desmopressin Acetate (0.02%), 0.2mg/ml	Diclofenac Sodium Oint, 0.1% (ophthalmic)	Idoxuridine Ophthalmic, 0.1%
Phenobarbital Sodium, 65mg/ml	Prednisone, 10 mg/ml	Tacrolimus, 0.02% (ophthalmic drops)
Tacrolimus, 0.03% (ophthalmic drops)	Tacrolimus Ointment, 0.03% (ophthalmic)	Ticarcillin in Pluronic, 250mg/ml gel
Xylazine 100mg/ml

Specialty Medicine Compounding Pharmacy has begun notifying its customers by mail and is arranging for the return of all recalled medication. Customers with questions regarding this recall may contact the pharmacy at 248-446-2643, Monday through Friday, between 8:00 a.m. and 5:00 p.m. EDT.

Customers that have product which is being recalled should stop using it and contact the pharmacy to arrange for return of unused product. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using these products. Adverse reactions may be reported to the FDA’s MedWatch program via:

• Online: www.fda.gov/medwatch/report.htm
• Mail: use postage-paid, pre-addressed Form FDA 3500 at www.fda.gov/MedWatch/getforms.htm.
• Fax: 1-800-FDA-0178

“We are committed to working cooperatively with state and federal health officials to resolve this issue as quickly as possible,” said Kenny Walkup, R.Ph, president of Specialty Medicine Compounding Pharmacy. “We apologize for the inconvenience that this voluntary recall may cause our valued customers, but their safety is paramount.”