The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0142-2015·Announced 2014-11-05

Martin Avenue Pharmacy Recalls Tobramycin Eye Drops for Sterility Concerns

Martin Avenue Pharmacy is voluntarily recalling Tobramycin eye drops due to quality control issues that may compromise sterility.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classified this as an FDA Class II recall. Per the rubric, FDA Class II recalls involving significant risks such as sterility assurance failures in sterile preparations are categorized as Severe (Score 4), as they pose a risk of serious temporary or medically reversible health consequences.

Plain-English summary

Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within their expiry date. This action includes Tobramycin (PF) 15 mg/mL ophthalmic solution packaged in opaque squeeze bottle eye droppers. The specific lot number is 08012014@7, with an expiration date of 9/30/2014. The product was distributed nationwide.

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.

Consumers who have this product should stop using it and contact Martin Avenue Pharmacy, Inc. or their healthcare provider for further instructions. The recall covers all compounded sterile preparations within expiry, not just the specific Tobramycin lot listed.

The recalled product

Product
Tobramycin (PF) 15 mg/mL opthalmic solution packaged in 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: 08012014@7
  • Exp 9/30/2014

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 →

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