The Recall Desk
SevereFDA (Drugs)·D-0107-2015·Announced 2014-11-05

Martin Avenue Pharmacy Recalls Compounded Injectable Preparations for Sterility Concerns

Martin Avenue Pharmacy is voluntarily recalling compounded sterile injectable preparations due to quality control observations that risk 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 source text explicitly states the agency classification is Class II. According to the severity rubric, FDA Class II recalls are assigned a score of 4 (Severe).

Plain-English summary

Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within their expiry dates. The specific product identified is "NB2014" 30 mg/6 mg/300 mcg/0.3 mg/mL (phentolamine mesylate, papaverine, alprostadil, atropine) injectable, packaged in a clear glass injectable vial. The recall is associated with Lot Numbers 07152014@52 (Exp 9/30/2014) and 07202014@7 (Exp 10/18/2014).

The recall was initiated following a recent FDA inspection. During the inspection, observations were made regarding certain quality control procedures that present a risk to sterility assurance. The agency classification for this recall is Class II.

The distribution pattern for the affected 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 discontinued and returned to the pharmacy or disposed of according to local regulations. No specific instructions for consumer action beyond identifying the affected lots are provided in the source text.

The recalled product

Product
"NB2014" 30 mg/6 mg/300 mcg/0.3 mg/mL (phentolamine mesylate, papaverine, alprostadil, atropine) injectable packaged in a clear glass injectable vial, 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 (4)

  • Lot Number: 07152014@52
  • Exp 9/30/2014
  • 07202014@7
  • Exp 10/18/2014

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 →

Related recalls

Same manufacturer · Martin Avenue Pharmacy, Inc.

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Same hazard · sterility assurance

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