The Recall Desk
SevereFDA (Drugs)·D-0085-2015·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 Hyaluronidase base vehicle, due to quality control issues affecting sterility assurance.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II and involves a risk to sterility assurance for injectable products, which aligns with the rubric criteria for Severe severity involving significant injury risks or Class II classifications with potential for serious harm.

Plain-English summary

Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within their expiry dates. This recall includes Hyaluronidase base vehicle (PF) solution packaged in amber glass injectable vials, specifically Lot Number 08192014@45 with an expiration date of 9/18/2014. The 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 affected preparations. The agency has classified this recall as Class II.

Consumers and healthcare providers who possess these products should stop using them and contact Martin Avenue Pharmacy, Inc. or their healthcare provider for further instructions on disposal or replacement.

The recalled product

Product
Hyaluronidase base vehicle (PF) 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: 08192014@45
  • Exp 9/18/2014

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 →