Main Street Compounding Pharmacy Recalls Oral B-12 Due to Adverse Reactions
Main Street Compounding Pharmacy is recalling Oral B-12 30ml cotton candy flavor after 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 reports of skin abscesses, which constitute significant injury reports under the severity rubric.
Plain-English summary
Main Street Family Pharmacy, LLC is recalling 82 units of Oral B-12 30ml in cotton candy flavor. 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. All codes were distributed prior to and including May 23, 2013.
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 source text does not specify if the B-12 product itself caused the abscesses or if the recall is precautionary due to the shared manufacturing facility.
Consumers who have this product should stop using it and contact Main Street Family Pharmacy, LLC at 888-658-6200 for further instructions.
The recalled product
- Product
- Oral B-12 30ml--cotton candy, 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
- 82
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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