The Recall Desk
HighFDA (Drugs)·D-0121-2015·Announced 2014-11-05

Martin Avenue Pharmacy Recalls Pilocarpine Eye Drops Due to Sterility Concerns

Martin Avenue Pharmacy is voluntarily recalling Pilocarpine 0.25% ophthalmic solution 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 involves a risk-of-harm product (sterility failure in a sterile preparation) where injury has not yet been reported, fitting the High severity criteria.

Plain-English summary

Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of Pilocarpine (PF) 0.25% ophthalmic solution packaged in an opaque squeeze bottle eye dropper. The affected product is a 5 mL compounded sterile preparation with Lot Number 07202014@11 and an expiration date of 10/18/2014. The recall is initiated in connection with a recent FDA inspection that identified observations associated with certain quality control procedures.

The recall is due to a lack of assurance of sterility. The quality control issues present a risk to the sterility assurance of the compounded sterile preparations. The source text does not specify the number of units recalled or report any illnesses or injuries associated with the product.

Consumers who have this specific lot of Pilocarpine eye drops should stop using the product and contact Martin Avenue Pharmacy, Inc. or their healthcare provider for further instructions. The recall is voluntary and covers all compounded sterile preparations within expiry from this facility.

The recalled product

Product
Pilocarpine (PF) 0.25% opthalmic solution packaged in an opaque squeeze bottle eye dropper, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
Manufacturer
Martin Avenue Pharmacy, Inc.
Category
Drug — Compounded Sterile Preparation
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 (2)

  • Lot Number: 07202014@11
  • 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 failure

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