The Recall Desk
SevereFDA (Drugs)·D-0130-2015·Announced 2014-11-05

Martin Avenue Pharmacy Recalls Quad Mix Injectable Due to Sterility Concerns

Martin Avenue Pharmacy is voluntarily recalling Quad Mix injectable vials 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, which aligns with the rubric criteria for Severe severity (FDA Class II with potential for significant injury).

Plain-English summary

Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within their expiry dates. The specific product involved is Quad mix, 9 mg/1 mg/10 mcg/0.1 mg/mL (papaverine, phentolamine mesylate, alprostadil, atropine) injectable, packaged in a clear glass injectable vial with a silver crimp top. The affected lots are 07182014@46 (Exp 10/16/2014) and 08192014@40 (Exp 11/17/2014).

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 compounded preparations. The agency has classified this recall as Class II.

The distribution pattern for these products is nationwide. Consumers and healthcare providers should check their inventory for the specific lot numbers and expiration dates listed above. If the product is found, it should be stopped from use and returned to the pharmacy or manufacturer for disposal or credit, in accordance with standard recall procedures.

The recalled product

Product
Quad mix, 9 mg/1 mg/10 mcg/0.1 mg/mL (papaverine, phentolamine mesylate, alprostadil, atropine) injectable packaged in a clear glass injectable vial with silver crimp top and sold under the Martin Avenue Pharmacy brand.

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: 07182014@46
  • Exp 10/16/2014
  • 08192014@40
  • Exp 11/17/2014

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 →