The Recall Desk
HighFDA (Drugs)·D-0061-2015·Announced 2014-11-05

Martin Avenue Pharmacy Recalls Atropine Sulfate Injectable Vials

Martin Avenue Pharmacy is voluntarily recalling Atropine sulfate 2 mg/mL injectable vials due to quality control issues that risk 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 is classified as FDA Class II and involves a risk to sterility assurance for injectable drugs, which fits the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of Atropine sulfate 2 mg/mL injectable vials. The affected product is packaged in amber glass injectable vials and is identified by Lot Number 07152014@39 with an expiration date of 10/13/2014. The recall covers all compounded sterile preparations within their expiry dates.

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 products. The distribution pattern for the recalled items is nationwide.

Consumers and healthcare providers should check their inventory for the specific lot number and expiration date 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 product are provided in the source text.

The recalled product

Product
Atropine sulfate 2 mg/mL injectable packaged in an amber glass injectable vial, 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: 07152014@39
  • Exp 10/13/2014

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 →