Main Street Compounding Pharmacy Recalls HCG 330 iu Prefilled Syringes
Main Street Family Pharmacy, LLC is recalling HCG 330 iu prefilled syringes due to reports of skin abscesses linked to a related 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 reported adverse reactions (skin abscesses), which aligns with the rubric criteria for Severe severity involving hospitalization or significant injury reports.
Plain-English summary
Main Street Family Pharmacy, LLC is recalling 6,643 units of HCG 330 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 recall was initiated after the firm received 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 FDA has classified this recall as Class II.
Consumers who have these HCG 330 iu prefilled syringes should stop using them and contact Main Street Family Pharmacy, LLC at 888-658-6200 for further instructions.
The recalled product
- Product
- HCG 330 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
- 6,643
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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