The Recall Desk
HighFDA (Drugs)·D-0135-2015·Announced 2014-11-05

Martin Avenue Pharmacy Recalls Compounded Sterile Preparations Due to Sterility Concerns

Martin Avenue Pharmacy is voluntarily recalling all compounded sterile preparations within expiry 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 injectable products, which is a high-risk hazard where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products.

Plain-English summary

Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within their expiry dates. This action is being taken in connection with a recent FDA inspection.

The recall was initiated due to observations associated with certain quality control procedures that present a risk to sterility assurance. The specific product identified in the recall notice is Sodium tetradecyl sulfate 3% (PF) injectable, packaged in an amber glass injectable vial. The affected lots are 08062014@31 (Exp 9/5/2014) and 08112014@47 (Exp 9/10/2014).

The recall is distributed nationwide. Consumers and healthcare providers should check their inventory for these specific lot numbers and stop using the affected products. No specific instructions for disposal or return are provided in the source text.

The recalled product

Product
Sodium tetradecyl sulfate 3% (PF) injectable 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 (4)

  • Lot Number: 08062014@31
  • Exp 9/5/2014
  • 08112014@47
  • Exp 9/10/2014

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 →