The Recall Desk
HighFDA (Drugs)·D-0131-2015·Announced 2014-11-05

Martin Avenue Pharmacy Recalls Compounded Sterile Preparations Due to Sterility Concerns

Martin Avenue Pharmacy is voluntarily recalling compounded sterile preparations, including triamcinolone injection solutions, due to quality control issues affecting 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 is classified as FDA Class II and involves a risk to sterility assurance for injectable medications, which poses a significant risk of harm (infection) even though no specific illnesses or injuries are reported in the source text.

Plain-English summary

Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within their expiry dates. This recall includes Rescue solution with triamcinolone (lidocaine, bupivacaine, heparin, triamcinolone) injection solution packaged in amber glass injectable vials. The affected products were distributed nationwide.

The recall was initiated following a recent FDA inspection that identified observations associated with certain quality control procedures. These observations present a risk to the assurance of sterility for the compounded preparations.

Consumers and healthcare providers should check their inventory for these products and stop using them. The specific lot number identified in the recall is 08112014@41, with an expiration date of 9/10/2014. Individuals should contact their pharmacist or the recalling firm for further instructions on disposal or replacement.

The recalled product

Product
Rescue solution with triamcinolone (lidocaine, bupivacaine, heparin, triamcinolone) injection solution 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 (2)

  • Lot Number: 08112014@41
  • 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 →