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Specialty Medicine Compounding Pharmacy Issues Voluntary Recall of Certain Unexpired Compounded Sterile Products

Contact
Consumer:
248-446-2643

Media:
David Ball / Greg Turner
617-243-9950
david@ballcg.com / greg@ballcg.com
 

FOR IMMEDIATE RELEASE - October 19, 2013 - South Lyon, Mich. – 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 SulfateAminophylline PF, 25mg/mlBevacizumab, 0.06ml (repackaged)
Bevacizumab, 0.11ml (repackaged)Bi-Mix, 15mg/0.5mgBiotin IM, 1mg/ml
Calcium Chloride PF, 500mg/mlCeftazidime, 22.5mg/ml (ophthalmic)Clorpactin, 0.1%
Combo Eye GelCyanocobalamin, 1000mcg/mlCyclopentolate HCL, 2% (ophthalmic)
Dexamethasone NaPO4  ionto-pf, 4mg/mlDextrose Vial, 50%DMSO/Glutath, 3.75%/1.75% (ophthalmic)
Edetate Disodium (0.05m), 1.7%Epinephrine (PF/SF), 0.5ml in 3mlEpinephrine PF SF (0.3ml), 1:1000
Epinephrine PF SF (1ml), 1:1000Fentanyl PF, 50mcg/mlFluconazole/Gentamicin, 200mg/480mg/1L
Fluorouracil PF, 50mg/mlGatifloxacin, 0.2ml 0.5% (ophthalmic) (repackaged)Glutathione PF, 60mg/ml inhalation
Glycerin-Chromated (w/v), 72%Hyaluronidase, pf 100U/mlHyaluronidase, pf 150U/ml
Hydroxocobalamin, 10,000mcg/mlHydroxocobalamin/thiamine, 1mg/100mg/mlLidocaine/Sodium Chloride, 0.4%/18%
Magnesium Sulfate, 1gm/50mlMagnesium Sulfate, 2gm/50mlMethocarbamol, 100mg/ml (repackaged)
Methylcobalamin, 1000mcg/mlMethylcobalamin, 10mg/mlMethylcobalamin, 25mg/ml
Methylcobalamin, 5000mcg/mlMethylcobalamin, PF 25mg/mlMultitrace-4 Pediatric Injection
Naloxone HCL, 0.4mg/mlNaltrexone MCV, 1mg/mlNeomycin, 333mg/ml
Papav/Phentol/PG E1, 30mg/1mg/20mcg/mlPapaverine HCL, (10ml) 30mg/mlPapaverine HCL, (2ml) 30mg/ml
Papaverine HCL, 30mg/mlPhenol, 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/mlQuad Mix, 0.1mg/30mg/2mg/20mcg/ml
Quad Mix, 0.1mg/30mg/2mg/50mcg/mlQuad Mix, 0.1mg/9mg/1mg/10mcg/mlQuad 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/20mcg/ml
Testos Cypionate in Oil, 100mg/mlTestos Cypionate in Oil, 200mg/mlTestos Cypionate in Olive Oil, 200mg/ml
Tranexamic Acid, 2gm/100mlTranexamic Acid, 2gm/75mlTriple Mix, 15mg/0.5mg/10mcg/ml
Triple Mix, 15mg/1mg/20mcg/mlTriple Mix, 30mg/1mg/10mcg/mlTriple Mix, 30mg/1mg/20mcg/ml
Triple Mix, 30mg/1mg/40mcg/mlTropicamide, 1%Vancomycin HCL, 10mg/ml (ophthalmic)
Vigamox in BSS (0.15%), 0.75mg/0.5ml  

Veterinary Products

Amikacin Sulfate, 250mg/mlBuprenorphine HCL, 0.3mg/mlBuprenorphine HCL, 0.6mg/ml
Ceftazidime in pluronic 250mg/ml gelCyclosporin A Oint, 0.2% (ophthalmic)Cyclosporin MCT, 0.2% (ophthalmic)
Cyclosporin MCT, 1% (ophthalmic)Desmopressin Acetate (0.01%), 0.1mg/mlDesmopressin Acetate (0.0125%), 0.125mg/ml
Desmopressin Acetate (0.02%), 0.2mg/mlDiclofenac Sodium Oint, 0.1% (ophthalmic)Idoxuridine Ophthalmic, 0.1%
Phenobarbital Sodium, 65mg/mlPrednisone, 10mg/mlTacrolimus, 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 health care 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:

“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.”

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

 

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