The Recall Desk
SevereFDA (Drugs)·D-291-2014·Announced 2013-12-11

Main Street Compounding Pharmacy Recalls Testosterone Cypionate Due to Adverse Reactions

Main Street Family Pharmacy is recalling Testosterone Cypionate 100mg/ml after receiving reports of skin abscesses linked to a different 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 or Class II classifications with adverse events.

Plain-English summary

Main Street Family Pharmacy, LLC is recalling Testosterone Cypionate 100mg/ml vials. 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, a different product manufactured by the same pharmacy.

The recalled Testosterone Cypionate 100mg/ml units were 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. The products were distributed prior to and including May 23, 2013.

Consumers who have purchased or received this product should contact their healthcare provider or the pharmacy for instructions on how to return the product or obtain a replacement. The FDA classifies this recall as Class II, indicating a reasonable probability that use of the product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
Testosterone Cypionate 100mg/ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200
Affected units
2

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)

  • 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 →