The Recall Desk
SevereFDA (Drugs)·D-0089-2015·Announced 2014-11-05

Martin Avenue Pharmacy Recalls Compounded Sterile Preparations for Sterility Assurance Concerns

Martin Avenue Pharmacy is voluntarily recalling all compounded sterile preparations within expiry due to quality control observations that present a risk to 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 in injectable products, which aligns with the rubric criteria for Severe severity (FDA Class II with potential for hospitalization or significant injury).

Plain-English summary

Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within their expiry dates. This action is being taken in connection with a recent FDA inspection.

The recall was initiated due to observations associated with certain quality control procedures that present a risk to sterility assurance. The source text does not specify the exact number of units affected or the specific distribution locations beyond the pharmacy's location in Naperville, IL.

Consumers and healthcare providers should stop using the affected products and contact Martin Avenue Pharmacy, Inc. for further instructions or a refund. The recall is classified as Class II by the FDA.

The recalled product

Product
Hydromorphone/bupivacaine (PF) 0.5 mg/0.2 mg/mL injectable packaged in 30 mL or 60 mL syringes, 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 (2)

  • Lot Number: 08152014@34
  • Exp 9/14/2014

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 →

Related recalls

Same manufacturer · Martin Avenue Pharmacy, Inc.

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Same hazard · sterility assurance

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