The Recall Desk
SevereFDA (Drugs)·D-097-2014·Announced 2013-12-11

Main Street Compounding Pharmacy Recalls Glutathione Due to Adverse Reaction Reports

Main Street Family Pharmacy is recalling 19 units of compounded Glutathione after receiving seven reports of skin abscesses.

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

Plain-English summary

Main Street Family Pharmacy, LLC is recalling 19 units of Glutathione "Reduced" 200mg/ml. 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 Glutathione product itself was contaminated or if the adverse reactions were directly caused by the recalled Glutathione units, noting only the potential link to the methylprednisolone vials.

Consumers who have purchased or possess this product should stop using it and contact the recalling firm, Main Street Family Pharmacy, LLC, at 888-658-6200 for further instructions.

The recalled product

Product
Glutathione "Reduced" 200mg/ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200
Affected units
19

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 →