FDA Recalls Compounded HCG 10000u Due to Adverse Skin Reactions
Main Street Family Pharmacy is recalling HCG 10000u vials after reports of skin abscesses linked to compounded methylprednisolone.
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 skin abscesses, which are significant injury reports consistent with the 'Severe' rubric criteria.
Plain-English summary
The U.S. Food and Drug Administration has issued a Class II recall for HCG 10000u compounded by Main Street Family Pharmacy, LLC. The recall involves 180 units of the product distributed nationwide to specific states and the District of Columbia.
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 if the HCG product itself contained the methylprednisolone or if the reports were associated with a separate product line from the same facility.
Consumers who have purchased HCG 10000u from Main Street Compounding Pharmacy should contact the firm at 888-658-6200 for instructions on how to return the product. The recall covers all codes distributed prior to and including May 23, 2013.
The recalled product
- Product
- HCG 10000u, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200
- Manufacturer
- Main Street Family Pharmacy, LLC
- Category
- Drug — Compounded Prescription
- Affected units
- 180
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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