The Recall Desk
HighFDA (Drugs)·D-0060-2015·Announced 2014-11-05

Martin Avenue Pharmacy Recalls Atropine Sulfate Injectable Due to Sterility Concerns

Martin Avenue Pharmacy is voluntarily recalling Atropine sulfate 1 mg/mL injectable vials 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 is classified as FDA Class II and involves a risk to sterility assurance for an injectable drug, which fits the rubric 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 1 mg/mL injectable packaged in amber glass vials. The recall covers all compounded sterile preparations within their expiry date. The specific lot number is 08192014@36, with an expiration date of 11/17/2014. The product was distributed nationwide.

The recall was initiated following a recent FDA inspection. The inspection identified observations associated with certain quality control procedures that present a risk to sterility assurance. This lack of assurance of sterility is the primary reason for the recall.

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 stopped from use and returned to the pharmacy or disposed of according to local regulations. No specific instructions for disposal are provided in the source text.

The recalled product

Product
Atropine sulfate 1 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: 08192014@36
  • 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 →