The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-197-2014·Announced 2013-12-11

Main Street Compounding Pharmacy Recalls Compounded Methylprednisolone Vials

Main Street Compounding Pharmacy is recalling compounded preservative-free methylprednisolone vials due to reports of skin abscesses.

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 Class II, and the source text reports specific adverse reactions (skin abscesses), which aligns with the rubric criteria for Severe severity involving injury reports.

Plain-English summary

Main Street Family Pharmacy, LLC is recalling compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. The recall was initiated after the firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to the product.

The source text does not specify the exact distribution scope, lot numbers, or expiration dates for the affected units. Consumers who have received this product should contact their healthcare provider or the recalling firm for further instructions.

The recalled product

Product
Marcaine .2%/NS 450ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200
Affected units
143

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 →

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