Main Street Compounding Pharmacy Recalls Mitomycin C Due to Adverse Reactions
Main Street Family Pharmacy, LLC is recalling 12 units of Mitomycin C after receiving seven reports of skin abscesses potentially linked to the product.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class II, and the source text reports seven instances of adverse reactions (skin abscesses), which aligns with the rubric criteria for Severe (FDA Class II with hospitalization reports or significant injury reports).
Plain-English summary
Main Street Family Pharmacy, LLC is recalling 12 units of Mitomycin C. The recall is being conducted by the U.S. Food and Drug Administration (FDA) under recall number D-250-2014.
The firm initiated the recall after receiving seven reports of adverse reactions in the form of skin abscesses. These reactions were potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. The source text does not specify the exact mechanism of the link between the recalled Mitomycin C and the reported adverse reactions.
The recalled product was distributed nationwide to the following states and districts: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV. All codes distributed prior to and including 05/23/2013 are affected. Consumers and healthcare providers should stop using the product and contact the recalling firm for further instructions.
The recalled product
- Product
- Mitomycin C, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200
- Manufacturer
- Main Street Family Pharmacy, LLC
- Category
- Drug — Compounded Drug
- Affected units
- 12
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- all codes distributed prior to and including 05/23/2013
Distribution
Part of a larger recall action
This product is one of 299 recalled by Main Street Family Pharmacy, LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 299 products in this recall →Related recalls
Same manufacturer · Main Street Family Pharmacy, LLC
See all →- SevereMain Street Compounding Pharmacy Recalls Acetylcystein 10% Vials
FDA (Drugs) · 2013-12-11
- SevereMain Street Compounding Pharmacy Recalls Minoxidil 10% Due to Adverse Reactions
FDA (Drugs) · 2013-12-11
- SevereMain Street Compounding Pharmacy Recalls HCG 11000u w/B-12
FDA (Drugs) · 2013-12-11
- SevereMain Street Compounding Pharmacy Recalls Brompheniramine Due to Adverse Reactions
FDA (Drugs) · 2013-12-11
- SevereMain Street Compounding Pharmacy Recalls Methylcobalamin Due to Adverse Reaction Reports
FDA (Drugs) · 2013-12-11
Same hazard · skin abscess
See all →- SevereMain Street Compounding Pharmacy Recalls Lipotropic 10ml with B-12 and L-Carnitine
FDA (Drugs) · 2013-12-11
- SevereMain Street Compounding Pharmacy Recalls Testosterone Pellets Due to Adverse Reactions
FDA (Drugs) · 2013-12-11
- SevereMain Street Compounding Pharmacy Recalls Dexamethasone LA Due to Adverse Reactions
FDA (Drugs) · 2013-12-11