Main Street Compounding Pharmacy Recalls Betamethasone Due to Skin Abscess Reports
Main Street Family Pharmacy, LLC is recalling Betamethasone 6mg 10ml vials after receiving seven reports of skin abscesses potentially linked to the product.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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 specific adverse reactions (skin abscesses), which aligns with the rubric criterion for Severe severity involving Class II recalls with injury reports.
Plain-English summary
Main Street Family Pharmacy, LLC is recalling Betamethasone 6mg 10ml vials. The recall involves 6,085 units distributed nationwide to 38 states and the District of Columbia. The firm identified the need for the recall after receiving seven reports of adverse reactions in the form of skin abscesses potentially linked to the compounded product.
The source text notes that the adverse reactions were potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials, although the structured product information identifies the recalled item as Betamethasone 6mg 10ml. The recall covers all codes distributed prior to and including May 23, 2013.
Consumers who have this product should stop using it and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- Betamethasone 6mg 10ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200
- Manufacturer
- Main Street Family Pharmacy, LLC
- Category
- Drug — Compounded Steroid
- Affected units
- 6,085
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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