Main Street Compounding Pharmacy Recalls HCG 340 iu Prefilled Syringes
Main Street Family Pharmacy, LLC is recalling HCG 340 iu prefilled syringes due to adverse reactions reported for 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 (skin abscesses), which aligns with the rubric criteria for Severe (Class II with injury reports).
Plain-English summary
Main Street Family Pharmacy, LLC is recalling 5,315 units of HCG 340 iu prefilled syringes. The recall covers all codes distributed prior to and including May 23, 2013. The products 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.
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 recalled HCG syringes.
Consumers who have the recalled HCG 340 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 340 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 Medication
- Affected units
- 5,315
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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