The Recall Desk
HighFDA (Drugs)·D-0062-2015·Announced 2014-11-05

Martin Avenue Pharmacy Recalls Bacteriostatic Water for Injection

Martin Avenue Pharmacy is voluntarily recalling bacteriostatic water for injection 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 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.

Plain-English summary

Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within their expiry dates. The specific product involved is bacteriostatic water for injection packaged in amber glass injectable vials. The recall is being initiated in connection with a recent FDA inspection.

The recall was triggered by observations during the inspection regarding certain quality control procedures. These observations present a risk to the assurance of sterility for the affected products. The source text does not specify the number of units recalled or report any illnesses or injuries associated with the use of these products.

Consumers who have these products should stop using them and contact Martin Avenue Pharmacy, Inc. or their healthcare provider for further instructions. The recall covers products distributed nationwide.

The recalled product

Product
Bacteriostatic water for 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 (10)

  • Lot Number: 03082014@2
  • Exp 9/4/2014
  • 04142014@8
  • Exp 10/11/2014
  • 05242014@2
  • Exp 11/20/2014
  • 06202014@20
  • Exp 12/17/2014
  • 08192014@33
  • Exp 2/15/2015

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 →