Updated Recall Information: On June 6, 2013, the FDA reported that it has identified bacterial and fungal growth in samples from two unopened vials of preservative-free (PF) methylprednisolone acetate (MPA) manufactured by Main Street Family Pharmacy. The microbial growth was seen in samples from two separate lots. Additional samples and lots of PF MPA are still under evaluation, as well as other sterile products produced by Main Street. The FDA has received reports of skin and soft tissue abscesses associated with Main Street Family Pharmacy MPA.
Main Street Family Pharmacy, LLC has recalled of all lots of all products marketed as sterile that were 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.
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).
These products were supplied to the offices of licensed medical professionals and patients nationwide. The sterile products include all injectables with the Main Street Family Pharmacy name.
Recall List
B-12 0.5ml prefilled syringe
Adenosine 35mg/ml 30ml
Adenosine 3mg 2mlAdenosine 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 ½ 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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