The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0109-2015·Announced 2014-11-05

Martin Avenue Pharmacy Recalls Paraben Water for Injection Due to Sterility Concerns

Martin Avenue Pharmacy is voluntarily recalling Paraben water for injection because quality control observations during an FDA inspection raised concerns about sterility assurance.

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 classification is FDA Class II, and the hazard involves a lack of assurance of sterility in an injectable product, which poses a significant risk of serious injury or infection.

Plain-English summary

Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of Paraben water for injection packaged in sterile 1000 mL clear bottles. The recall involves three specific lots: 03102014@23 (Exp 9/6/2014), 05282014@16 (Exp 11/24/2014), and 08132014@18 (Exp 2/9/2015). The products were 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 sterile preparations. The agency has classified this recall as Class II.

Consumers and healthcare providers should check their inventory for the specific lot numbers and expiration dates listed above. If you possess these products, you should stop using them and contact Martin Avenue Pharmacy, Inc. for instructions on return or disposal.

The recalled product

Product
Paraben water for injection packaged in a sterile 1000 mL clear bottle, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
Manufacturer
Martin Avenue Pharmacy, Inc.
Category
Drug — Compounded Sterile Preparation
Hazard
Affected units
3

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 (6)

  • Lot Number: 03102014@23
  • Exp 9/6/2014
  • 05282014@16
  • Exp 11/24/2014
  • 08132014@18
  • Exp 2/9/2015

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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