The Recall Desk
HighFDA (Drugs)·D-0145-2015·Announced 2014-11-05

Martin Avenue Pharmacy Recalls Trimethoprim/Sulfadiazine Injection Due to Sterility Concerns

Martin Avenue Pharmacy is voluntarily recalling trimethoprim/sulfadiazine excipient stock solution injections due to quality control issues that risk 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-of-harm product (sterility assurance) where injury has not yet been reported, fitting the High severity criteria for theoretical hazards without confirmed illness.

Plain-English summary

Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within their expiry date. This action includes trimethoprim/sulfadiazine excipient stock solution injections packaged in amber glass injectable vials. The specific lot number is 06252014@23, with an expiration date of 12/22/2014. The product quantity is 100 mL.

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

Consumers and healthcare providers should stop using the recalled products immediately. They should contact Martin Avenue Pharmacy, Inc. for further instructions on how to return or dispose of the medication.

The recalled product

Product
Trimethoprim/sulfadiazine excipient stock solution 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 (2)

  • Lot Number: 06252014@23
  • Exp 12/22/2014

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 →