Main Street Compounding Pharmacy Recalls B-12 Syringes Due to Adverse Reactions
Main Street Family Pharmacy is recalling 15 units of B-12 1ml prefilled syringes after receiving seven 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 reported adverse reactions (skin abscesses), which aligns with the rubric criteria for Severe severity involving hospitalization reports or significant injury.
Plain-English summary
Main Street Family Pharmacy, LLC is recalling 15 units of B-12 1ml prefilled syringes. The recall is associated with the pharmacy's compounded preservative-free methylprednisolone 80mg/ml 10 ml vials, 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. The affected units are those with codes distributed prior to and including 05/23/2013.
The firm initiated the recall after receiving seven reports of adverse reactions in the form of skin abscesses. These reactions were potentially linked to the compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. The FDA has classified this recall as Class II.
Consumers who have purchased or received these B-12 1ml 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
- B-12 1ml prefilled syringe, 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
- 15
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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