The Recall Desk
HighFDA (Drugs)·D-0090-2015·Announced 2014-11-05

Martin Avenue Pharmacy Recalls Compounded Hydromorphone HCl Injectable Syringes

Martin Avenue Pharmacy is voluntarily recalling compounded Hydromorphone HCl injectable syringes 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 involves a risk to sterility assurance for an injectable drug, which is a high-risk product category. Per the rubric, risk-of-harm products where injury has not yet been reported are classified as High (3).

Plain-English summary

Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within their expiry dates. This action includes Hydromorphone HCl (PF) 1 mg/mL injectable packaged in 30 mL or 60 mL syringes. The recall is being initiated in connection with a recent FDA inspection.

The recall was triggered by observations associated with certain quality control procedures that present a risk to sterility assurance. The source text does not specify the exact nature of the quality control failures or the specific sterility risks involved.

The affected product is distributed nationwide. Consumers and healthcare providers should stop using the recalled product and contact Martin Avenue Pharmacy or their healthcare provider for further instructions. The source text does not report any illnesses or injuries associated with this recall.

The recalled product

Product
Hydromorphone HCl (PF) 1 mg/mL injectable packaged in 30 mL or 60 mL syringes, 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: 08182014@41
  • Exp 11/16/2014

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 →