The Recall Desk
SevereFDA (Drugs)·D-288-2014·Announced 2013-12-11

Main Street Compounding Pharmacy Recalls Testosterone Cypionate Vials

Main Street Compounding Pharmacy is recalling Testosterone Cypionate vials due to adverse reactions reported with 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.

Plain-English summary

Main Street Family Pharmacy, LLC is recalling 1,158 units of Testosterone Cypionate, 200mg 10ml vials. The product was distributed nationwide to 38 states and the District of Columbia 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, a different product manufactured by the same facility.

Consumers who possess the recalled Testosterone Cypionate vials should stop using them and contact the pharmacy for instructions on return or disposal.

The recalled product

Product
Testosterone Cypionate, 200mg 10ml Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200
Affected units
1,158

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 →