The Recall Desk
SevereFDA (Drugs)·D-0091-2015·Announced 2014-11-05

Martin Avenue Pharmacy Recalls Compounded Hydromorphone and Bupivacaine Injections

Martin Avenue Pharmacy is voluntarily recalling compounded hydromorphone and bupivacaine injections due to quality control issues that may compromise sterility.

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, which corresponds to a 'Severe' rating under the rubric, particularly given the risk to sterility assurance in a sterile injection product.

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/bupivacaine (PF) 10 mg/7.5 mg/mL injection 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 agency has classified this recall as Class II, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

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 on disposal or replacement.

The recalled product

Product
Hydromorphone HCl/bupivacaine (PF) 10 mg/7.5 mg/mL injection 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@45
  • Exp 9/17/2014

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 →