The Recall Desk
SevereFDA (Drugs)·D-044-2014·Announced 2013-12-11

Main Street Compounding Pharmacy Recalls B-12 Syringes Due to Adverse Reactions

Main Street Family Pharmacy is recalling 116 units of B-12 prefilled syringes following 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 significant injury reports.

Plain-English summary

Main Street Family Pharmacy, LLC is recalling 116 units of B-12 0.5ml prefilled syringes. 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 affected B-12 syringes were distributed nationwide to the following states and districts: 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. All codes distributed prior to and including 05/23/2013 are included in this recall.

Consumers who have these products should stop using them and contact Main Street Family Pharmacy at 888-658-6200 for instructions on how to return the product.

The recalled product

Product
B-12 0.5ml prefilled syringe, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200
Affected units
116

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

Distributed nationwide across the United States.

The notice also names 39 states specifically:

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.

See all 299 products in this recall →