Provider update: main street family pharmacy, llc issues voluntary nationwide recall of all sterile compounded products

FOR IMMEDIATE RELEASE
Main Street Family Pharmacy, LLC Issues Voluntary Nationwide Recal of Al Sterile
Compounded Products
News Media Contact: Joe Grillo
May 28, 2013, Newbern, Tennessee--Main Street Family Pharmacy, LLC today announced a
voluntary nationwide recall of all lots of all sterile products compounded by the pharmacy. The compounded products that are subject to the recal are those products with a use by date on or before November 20, 2013. The recal is being initiated due to seven (7) reported cases of adverse events in the form of skin abscesses, one of which appears to be fungal in nature. An investigation into the exact source of the adverse events is stil ongoing. This announcement updates a press release that was issued by the FDA on May 24, 2013. Patients are at increased risk for serious infections in the event a sterile product is compromised. To date Main Street Family Pharmacy, LLC has only received reports of adverse events in three (3) lots of preservative-free methylprednisolone acetate (MPA). At this time, there have been no additional reports of injury or illness associated with the use of our sterile compounded products. Patient safety is our highest priority and, out of an abundance of caution, we have decided to initiate this voluntary recal to include al sterile products. The These products were supplied to the offices of licensed medical professionals and patients. Sterile products included in this withdrawal were distributed nationwide. Main Street Family Pharmacy, LLC will be notifying customers by phone, fax, email, and/or mail to return the products to the pharmacy. The sterile products include al injectables with the Main Street Family Pharmacy name. Consumers or Health Care providers with questions regarding this recall may contact Main Street Family Pharmacy, LLC by phone at 731-627-2221 or 888-658-6200 from the hours of 8:30AM-6:00PM Central Standard Time Monday-Friday or email address at msfpcc@bel south.net. Patients who have received any sterile compounded product supplied by Main Street Family Pharmacy, LLC and have concerns should contact their healthcare provider. Adverse reactions or quality problems experienced with the use of sterile compounded products from Main Street Family Pharmacy, LLC may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or fax. * Regular Mail: use postage-paid pre-addressed Form FDA 3500 available at: Mail to address on the pre-addressed form This recal is being conducted with the knowledge of the U.S. Food and Drug Administration. B-12 mixture (Methylcobalamin 5mg/Folic Acid 5mg 8ml w/ 1 ml lidocaine Beta NA Phosphate, Beta Acetate (PF) 6mg 10ml Betamethasone Acetate 9img/ml PF 10ml/MDV Dexamethasone Acetate 8mg/Phosphate 4mg 10ml Glutathione "Reduced" 200mg/ml 30ml HCG 5000iu HCG 5000iu kit (Needle & 5ml syringe, Bacteriostatic Water 30ml,2 Alcohol prep pads HCG 500u/ml w/methylcobalamin 1mg/ml 10ml Lincomycin 300mg (Preservative Free) 10ml Lipo B = Mic w/B5 12.5/B6 25/B12 .25/Lido 50ml Lipo Blast (Mic w/B1,B2,B3,B5,B6,B7,B12, AMP & Lido) 50ml Lipo Blast w/o adenosine (Mic w/B1,B2,B3,B5,B6,B7,B12, & Lido) 50ml Mic w/B-12 .25/AMP 12.5mg/Lidocaine 50ml Lipotonix Plus-Mic B Complex Fat Burner 30ml Lipotropic 10ml with B-12 and L- Carnitine MALE HCG PK 2nd month (290, 300, 310, 320iu) MALE HCG PK 3rd month (320, 330, 340, 350iu) Medroxyprogesterone 150mg w/lidocaine 10ml Medroxyprogesterone 150mg w/lidocaine 1ml Medroxyprogesterone 150mg w/lidocaine 5ml (compounded) Methylpred 80mg (Preservative Free) 10ml Mic B w/Amp Mix 50ml Mic Combo w/methylcobalamin (Methionine/Inositol/Choline)175mcg/25/50/50 30ml Post-menopausal HCG Pk (250iu, 270iu, 290iu, 310iu) Post-menopausal HCG Pk 2nd month (310iu, 320iu, 320iu, 330iu) Post-menopausal HCG Pk 3rd month (340iu, 340iu, 350iu, 350iu) Pre-menopausal HCG PK (200iu, 220iu, 240iu, 260iu) Pre-menopausal HCG PK 2nd month (270iu, 280iu, 290iu, 300iu) Pre-Menopausal 3rd month (310iu, 320iu, 330iu, 340iu) Triamcinolone Diacetate 40mg 2ml Preservative Free Triamcinolone Acetonide 40mg 2ml Preservative Free. Triamcinolone Acetonide 10mg 5ml (compounded)

Source: http://www.ncpublichealth.info/docs/news/Mainstreetrecall.pdf