Main Street Compounding Pharmacy Recalls HCG 12000u Due to Adverse Reactions
Main Street Family Pharmacy is recalling HCG 12000u vials 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 recall is classified as FDA Class II and involves reported adverse reactions (skin abscesses), which aligns with the rubric criteria for Severe severity involving significant injury reports or Class II classifications with reported issues.
Plain-English summary
Main Street Family Pharmacy, LLC is recalling 16 units of HCG 12000u compounded by Main Street Compounding Pharmacy. The recall covers all codes distributed prior to and including May 23, 2013. The product was distributed nationwide to specific states including 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.
The firm initiated the recall after receiving seven reports of adverse reactions in the form of skin abscesses. These reactions are potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. The source text does not specify if the HCG 12000u product itself contained methylprednisolone or if the adverse reactions were directly caused by the HCG, noting only a potential link to the methylprednisolone vials.
Consumers who have purchased or received this product should contact Main Street Family Pharmacy, LLC at 888-658-6200 for further instructions on how to return or dispose of the medication. The recall is classified as Class II by the FDA.
The recalled product
- Product
- HCG 12000u, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200
- Manufacturer
- Main Street Family Pharmacy, LLC
- Category
- Drug — Compounded Medication
- Affected units
- 16
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.
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