The Recall Desk
SevereFDA (Drugs)·D-0764-2017·Announced 2017-05-24

Key Pharmacy Recalls Iron Special Injection Due to Sterility Concerns

Key Pharmacy and Compounding Center is recalling Iron Special 5mL multiple-dose vials due to a lack of assurance of sterility.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a lack of assurance of sterility in an injectable drug, which poses a significant risk of infection or serious injury.

Plain-English summary

Key Pharmacy and Compounding Center is recalling a specific lot of Iron Special 5mL multiple-dose vials. The product is an injection containing 60mg/1mg/5mcg/mL, prepared by the firm and distributed in the United States, Australia, and Canada.

The recall was initiated because the firm could not ensure the sterility of the compounded drugs. The affected lot is identified as Lot # t02-16-2017@108 with an expiration date of 5/18/2017.

Consumers and healthcare providers should stop using the affected vials and contact their healthcare provider or the recalling firm for further instructions.

The recalled product

Product
IRON SPECIAL 5ML MDV 60/10MG/5MCG/ML INJ, Injection, 60mg/1mg/5mcg/mL, Rx only, 5mL Glass /Multiple Dose vial, Prepared by Key Compounding Pharmacy
Manufacturer
Key Pharmacy and Compounding Center
Category
Drug — Compounded Injectable
Hazard
Affected units
2

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 # t02-16-2017@108
  • Exp 5/18/2017

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 79 recalled by Key Pharmacy and Compounding Center 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 79 products in this recall →

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Same manufacturer · Key Pharmacy and Compounding Center

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Same hazard · sterility

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