The Recall Desk
HighFDA (Drugs)·D-0087-2015·Announced 2014-11-05

Martin Avenue Pharmacy Recalls Compounded Sterile Preparations for Sterility Assurance Concerns

Martin Avenue Pharmacy is voluntarily recalling compounded sterile preparations, including hydrochloric acid/water for injection, 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 is classified as FDA Class II and involves a risk to sterility assurance for compounded sterile preparations, which fits the rubric for high-risk products where injury has not yet been reported.

Plain-English summary

Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within their expiry dates. The recall is being initiated in connection with 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 affected products.

The recall includes Hydrochloric acid/water for injection 10% (w/v) packaged in an amber glass dropper bottle, 90 mL. Specific lots affected include Lot Number 04252014@26 (Exp 10/22/2014) and Lot Number 07092014@17 (Exp 1/5/2015). The products were distributed nationwide.

Consumers and healthcare providers should stop using the recalled products and contact Martin Avenue Pharmacy, Inc. or their healthcare provider for further instructions. The recall is voluntary and is based on the risk to sterility assurance identified during the FDA inspection.

The recalled product

Product
Hydrochloric acid/water for injection 10% (w/v) packaged in an amber glass dropper bottle, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
Manufacturer
Martin Avenue Pharmacy, Inc.
Category
Drug — Compounded Sterile Preparations
Hazard

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: 04252014@26
  • Exp 10/22/2014
  • 07092014@17
  • Exp 1/5/2015

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 →

Related recalls

Same manufacturer · Martin Avenue Pharmacy, Inc.

See all →

Same hazard · sterility assurance

See all →