Recall -- Firm Press Release
FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.
Specialty Medicine Compounding Pharmacy Issues Voluntary Recall of Certain Unexpired Compounded Sterile Products
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:
|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/20mcg/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, 10mg/ml (ophthalmic)|
|Vigamox in BSS (0.15%), 0.75mg/0.5ml|
|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, 10mg/ml||Tacrolimus, 0.02% (ophthalmic drops)|
|Tacrolimus, 0.03% (ophthalmic drops)||Tacrolimus Ointment, 0.03% (ophthalmic)||Ticarcillin in Pluronic, 250mg/ml gel|
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:
- 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.”
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.