Main Street Family Pharmacy Recalls HCG 350 iu Prefilled Syringes
Main Street Family Pharmacy is recalling HCG 350 iu prefilled syringes due to adverse reactions reported with 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 agency classification is FDA Class II, and the source text reports seven adverse reactions involving skin abscesses, which aligns with the rubric criteria for Severe severity (Class II with injury reports).
Plain-English summary
Main Street Family Pharmacy, LLC is recalling 12,757 units of HCG 350 iu prefilled syringes. 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 this 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 syringes being recalled. The source text does not specify if the HCG syringes themselves caused the abscesses, but the recall is associated with these reports.
Consumers who have purchased these HCG 350 iu prefilled syringes should stop using them and contact Main Street Family Pharmacy, LLC at 888-658-6200 for instructions on how to return the product.
The recalled product
- Product
- HCG 350 iu prefilled syringes, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200
- Manufacturer
- Main Street Family Pharmacy, LLC
- Category
- Drug — Compounded Injectable
- Hazard
- Affected units
- 12,757
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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