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FDA: Complete list products recalled by Main Street Pharmacy due to associated adverse events

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  • FDA: Complete list products recalled by Main Street Pharmacy due to associated adverse events

    xhttp://www.fda.gov/Safety/Recalls/ucm354182.htm


    Main Street Family Pharmacy, LLC Issues Voluntary Nationwide Recall of All Sterile Compounded Products

    Contact
    Consumer
    :
    731-627-2221
    888-658-6200
    msfpcc@bellsouth.net

    Media
    :
    Joe Grillo
    617-951-0000 (office)
    617-429-6933 (cell)
    jgrillo@nicolazzo.com


    FOR IMMEDIATE RELEASE - 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 recall are those products with a use by date on or before November 20, 2013. The recall 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 still 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 recall to include all sterile products. The product list is attached.

    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 all 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@bellsouth.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.

    Online: http://www.fda.gov/MedWatch/report.htm
    Regular Mail: use postage-paid pre-addressed Form FDA 3500 available at: http://www.fda.gov/MedWatch/getforms.htm.
    Mail to address on the pre-addressed form
    Fax: 1-800-FDA-0178

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

    PRODUCT RECALL LIST

    B-12 0.5ml prefilled syringe
    Adenosine 35mg/ml 30ml
    Adenosine 3mg 2ml
    Adenosine 3mg/ml 4ml
    Adenosine 6mg/ml 2ml Vial
    Adenosine Monophosphate 50mg/ml 30ml
    Adenosine Monophosphate 35mg/ml 10ml
    Adenosine Monophosphate 50mg/ml 10ml
    AMIC-12 10ml
    AMIC-12 10ml w/out lido
    AMP injection 30ml
    B-12 (compounded) 30ml
    B-12 mixture (Methylcobalamin 5mg/Folic Acid 5mg 8ml w/ 1 ml lidocaine
    B-12 PFS
    Betamethasone 4mg 10ml sodium phosphate
    Betamethasone 6mg 10ml
    Beta NA Phosphate, Beta Acetate (PF) 6mg 10ml
    Betamethasone 6mg PF 10ml
    Betamethasone 7mg 10ml
    Betamethasone 9mg 10ml
    Betamethasone 9mg PF 1ml
    Betamethasone Acetate 9img/ml PF 10ml/MDV
    Betamethasone 10mg 10ml
    Bi-Mix 10ml
    Brompheniramine 10mg 10ml
    Depo-Testadiol 10ml
    Dexamethasone 10mg (PF) 1ml
    Dexamethasone 16mg 10ml
    Dexamethasone 16mg 30ml
    Dexamethasone Acetate 8mg/Phosphate 4mg 10ml
    Dexamethasone 8/4 30ml
    Dexamethasone 8mg 10ml
    Dexamethasone LA 16mg 10ml
    Dexamethasone LA 8mg 10mml
    Dexamethasone 4mg 30ml
    Dexamethasone LA 16mg 30ml
    Double Strength PGE1 40mcg/ml 2ml
    Double Strength PGE1 40mcg/ml 10ml
    Estradiol Cypionate 40mg 10ml
    Estradiol Valerate 40mg 10ml
    Estradiol Cypionate 5mg 10ml
    Estradiol Pellet 20mg
    Estradiol Pellet 37.5mg
    Estradiol Pellet 50mg
    Estradiol Pellets 10mg
    Estradiol Pellets 12.5mg
    Estradiol Pellets 12mg
    Estradiol Pellets 15mg
    Estradiol Pellets 25mg
    Estradiol Pellets 31mg
    Estradiol Pellets 6mg
    Glutathione "Reduced" 200mg/ml 30ml
    Gluthione 150mg/ml 30ml
    Gomenol 10ml
    HCG + Mannitol 5000u
    HCG 100 iu prefilled syringes
    HCG 10000u
    HCG 1000iu PFS
    HCG 11,000U
    HCG 110 iu prefilled syringes
    HCG 11000u/Methylcobalamin 8mg 10ml
    HCG 11000 w/B-12 (cyanocobalamin)
    HCG 12000u
    HCG 125 iu prefilled syringes
    HCG 140 iu prefilled syringes
    HCG 15,000u
    HCG 15000u w/b-12
    HCG 1500iu PFS
    HCG 170 iu prefilled syringes
    HCG 175 iu prefilled syringes
    HCG 180 iu prefilled syringes
    HCG 20,000u
    HCG 200 iu prefilled syringes
    HCG 2000IU
    HCG 2000iu PFS
    HCG 210 iu prefilled syringes
    HCG 220 iu prefilled syringes
    HCG 225 iu prefilled syringes
    HCG 230 iu prefilled syringes
    HCG 240 iu prefilled syringes
    HCG 250 iu prefilled syringes
    HCG 2500u
    HCG 260 iu prefilled syringes
    HCG 270 iu prefilled syringes
    HCG 275 iu prefilled syringes
    HCG 280 iu prefilled syringes
    HCG 290 iu prefilled syringes
    HCG 300 iu prefilled syringes
    HCG 3000IU

    HCG 310 iu prefilled syringes
    HCG 320 iu prefilled syringes
    HCG 330 iu prefilled syringes
    HCG 340 iu prefilled syringes
    HCG 350 iu prefilled syringes
    HCG 360ium PFS
    HCG 370 iu prefilled syringe
    HCG 380 iu prefilled syringes
    HCG 390iu prefilled syringes
    HCG 40,000u
    HCG 400 iu prefilled syringes
    HCG 450 iu prefilled syringes
    HCG 5,000U
    HCG 50 iu prefilled syringes
    HCG 500 SL tablet
    HCG 500/B-12 300 tablet
    HCG 500/Test 200 troches (soy base)
    HCG 5000iu
    HCG 5000iu kit (Needle & 5ml syringe, Bacteriostatic Water 30ml,2 Alcohol prep pads
    HCG 500u/ml w/methylcobalamin 1mg/ml 10ml
    HCG 60 iu prefilled syringes
    HCG 7000u
    HCG 8,000u
    HCG 80 iu prefilled syringes
    L-Arginine 100mg/ml 30ml
    L-Carnitine 30ml
    L-Carnitine 500mg/ml 50ml
    L-glutamine 30mg/ml 30ml vial
    L-glutathione 200mg/ml 30ml vial
    Lidocaine 2% MPF 2ml-compounded
    Lidocaine 4%/Phenylephrine 1% 1ml
    Lidocaine 4%/Phenylephrine 1% 5ml
    Lincomycin 300mg (Preservative Free) 10ml
    Lincomycin 300mg w/lidocaine 10ml
    Lipo-Shot 30ml
    Lipo B = Mic w/B5 12.5/B6 25/B12 .25/Lido 50ml
    Lipo B Complex 30ml
    Lipo B Complex 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
    Lipo C 30ml
    Mic w/B5/B6/B12/Lido/Amp 50ml
    Mic w/B-12 .25/AMP 12.5mg/Lidocaine 50ml
    Lipotonix B
    Lipotonix Plus-Mic B Complex Fat Burner 30ml
    Lipotonix Plus 10ml
    Lipotonix Plus 30ml
    Lipotonix Plus 30ml w/o methionine
    Lipotonix Plus w/Procaine/Chromium 10ml
    Lipotropic 1.5ml PFS
    Lipotropic 10ml
    Lipotropic 10ml with B-12 and L- Carnitine
    Lipotropic 1ml PFS
    Lipotropic 2ml PFS
    Lipotropic 30ml
    Lipotropic 30ml w/o methionine
    Lipotropic 50ml
    Lipotropic 50ml w/L-Carnitine
    Lipotropic 50ml w/o methionine
    MALE HCG PK (250, 260, 270, 280iu)
    MALE HCG PK 2nd month (290, 300, 310, 320iu)
    MALE HCG PK 3rd month (320, 330, 340, 350iu)
    Medroxyprogesterone 150mg PF 1ml
    Medroxyprogesterone 150mg w/lidocaine 10ml
    Medroxyprogesterone 150mg/ml 10ml
    Medroxyprogesterone 150mg w/lidocaine 1ml
    Medroxyprogesterone (PF) 150mg/ml 10ml
    Medroxyprogesterone 150mg w/lidocaine 5ml (compounded)
    Methylcobalamin 100mcg/ml 30ml
    Methylcobalamin 1000mcg/ml 30ml
    Methylcobalamin 1mg/ml 50ml
    Methylcobalamin 1mg/ml 30ml
    Methylcobalamin 30ml
    Methylcobalamin/Folate 5ml
    Methylcobalamin 12.5mg/ml 10ml
    Methylpred 80mg w/lido 1ml
    Methylpred 100mg 10ml
    Methylpred 100mg w/lidocaine 10ml
    Methylpred 20mg PF 5ml
    Methylpred 40mg w/lidocaine 10ml
    Methylpred 40mg PF 10ml
    Methylpred 40mg PF 1ml
    Methylpred 40mg PF 2ml
    Methylpred 40mg PF 5ml
    Methylpred 40mg w/lidocaine 1ml
    Methylpred 40mg 10ml
    Methylpred 80mg (Preservative Free) 10ml
    Methylpred 80mg 10ml

    Methylpred 80mg 1ml
    Methylpred 80mg PF 1ml
    Methylpred 80mg PF 5ml
    Methylpred 80mg w/lidocaine 10ml
    Methylpred 80mg w/lido 30ml
    Mic .05ml prefilled syringe
    Mic 25/50/50 30ml
    Mic/Cyanocobalamin 25/50/50 50ml
    MIC 25/50/50 formula w/333mg B-12 10ml
    Mic 30ml
    Mic B-Complex 30ml
    Mic B-Complex 50ml
    Mic B w/Amp Mix 50ml
    Mic Combo w/methylcobalamin (Methionine/Inositol/Choline)175mcg/25/50/50 30ml
    Mic Ultra (Methionine Free) 10ml
    Mic Ultra 30ml- Sulfur Free
    Mic Ultra 10ml
    Mic Ultra 30ml
    Mic Ultra 50ml
    Mic Ultra 50ml- Sulfur Free
    Mic Ultra 50ml- Sulfur Free w/ Lido
    Mic w/B-12 30ml
    Mic w/B-12 50ml
    Mic w/B6/B12/Lido 50ml
    Mitomycin 0.02%
    Mitomycin 0.04% 2.5ml
    Mitomycin C 1/2 Strength
    Mitomycin 20mg
    Mitomycin 2ml (full Strength)
    Mitomycin 40mg Compounded
    Mitomycin C
    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)
    Single Strength PGE1 20mcg 2ml
    Single Strength PGE1 20mcg/ml 10ml
    Taper A prefilled syringes
    Taper Pack B
    Taper Pack C
    Testosterone 200mg 10ml (compounded)
    Testosterone 200mg 30ml (compounded)
    Testosterone 210mg 10ml (compounded)
    Testosterone Cypionate 300mg/ml 10ml
    Testosterone Cypionate 250mg 10ml
    Testosterone Cypionate 210mg 10ml
    Testosterone Cypionate 300mg/ml 10ml
    Testosterone Pellet 112.5mg
    Testosterone Pellet 112mg
    Testosterone Pellet 12.5mg
    Testosterone Pellet 87.5mg
    Testosterone Pellets 100mg
    Testosterone Pellets 125mg
    Testosterone Pellets 200mg
    Testosterone Pellets 220mg
    Testosterone Pellets 225mg
    Testosterone Pellets 25mg
    Testosterone Pellets 37.5mg
    Testosterone Pellets 50mg
    Testosterone Pellets 75mg
    Testosterone Propionate 100mg/ml 10ml
    Tetracaine 2%/Pontocaine 60ml
    Tri-Mix 10ml
    Tri-Mix 5ml
    Triamcinolone Acetonide 10mg PF 5ml
    Triamcinolone Diacetate 40mg 2ml Preservative Free
    Triamcinolone 40mg/ml 5ml
    Triamcinolone Diacetate 40mg/ml 5 ml
    Triamcinolone Acetonide 40mg 2ml Preservative Free
    Triamcinolone Acetonide 10mg 5ml (compounded)
    Triamcinolone 40mg 10ml (PF)
    Triamcinolone Diacetate 40mg 10ml
    Triamcinolone 40mg 1ml
    Triamcinolone Acetonide 40mg PF 10ml
    Triamcinolone 40mg/ml 10ml
    Triamcinolone Acetonide 40mg/ml 10ml
    Triamcinolone D 40mg 1ml
    Triamcinolone PF 2ml
    Trypan Blue 1ml
    Wydase 1ml
    Wydase 5ml
    Wydase 150u/ml PF 5ml



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