FDA Recalls Compounded HCG 1000iu PFS Due to Adverse Reaction Reports
Main Street Family Pharmacy is recalling HCG 1000iu PFS after receiving reports of skin abscesses linked to a different compounded 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 reports of adverse reactions (skin abscesses), which aligns with the rubric criteria for Severe severity involving hospitalization or significant injury reports.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a recall for HCG 1000iu PFS manufactured by Main Street Family Pharmacy, LLC. The recall involves 115 units of the product, which were 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. All codes distributed prior to and including May 23, 2013, are affected.
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, a different product from the HCG 1000iu PFS being recalled. The FDA has classified this recall as Class II.
Consumers who have purchased or possess HCG 1000iu PFS from Main Street Family Pharmacy should stop using the product and contact the pharmacy at 888-658-6200 for further instructions on disposal or return.
The recalled product
- Product
- HCG 1000iu PFS, 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
- 115
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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