The Recall Desk
HighFDA (Drugs)·D-0140-2015·Announced 2014-11-05

Martin Avenue Pharmacy Recalls Compounded Testosterone Cypionate Injection

Martin Avenue Pharmacy is voluntarily recalling compounded Testosterone cypionate 200 mg/mL injections due to quality control observations that present a risk to sterility assurance.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a risk to sterility assurance for an injectable drug, which is a high-risk product category where injury has not yet been reported, fitting the 'High' severity criteria.

Plain-English summary

Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within their expiry dates. The specific product identified is Testosterone cypionate 200 mg/mL injection packaged in an amber glass injectable vial. The recall covers a quantity of 2,500 mL distributed nationwide.

The recall was initiated following a recent FDA inspection. During the inspection, observations were made regarding certain quality control procedures that present a risk to the assurance of sterility for the compounded preparations. The source text does not report any illnesses or injuries associated with this recall.

Consumers who have this product should stop using it and contact their healthcare provider or the pharmacy for further instructions. The affected lot numbers are 06112014@14 (Exp 9/9/2014), 07312014@17 (Exp 10/29/2014), and 08202014@1 (Exp 11/18/2014).

The recalled product

Product
Testosterone cypionate 200 mg/mL injection packaged in an amber glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.

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 (6)

  • Lot Number: 06112014@14
  • Exp 9/9/2014
  • 07312014@17
  • Exp 10/29/2014
  • 08202014@1
  • Exp 11/18/2014

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 118 recalled by Martin Avenue Pharmacy, Inc. 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 118 products in this recall →