The Recall Desk
SevereFDA (Drugs)·D-0763-2017·Announced 2017-05-24

Key Pharmacy Recalls Ferric Gluconate Injection Due to Sterility Concerns

Key Pharmacy and Compounding Center is recalling specific lots of Ferric Gluconate Injection because the firm cannot guarantee the sterility of the compounded drug.

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 voluntarily recalling specific lots of Ferric Gluconate Injection, 60mg/mL, which are packaged in 5mL and 10mL glass multiple-dose vials. The recall is being conducted because the firm lacks assurance of the sterility of these compounded sterile drugs.

The affected product is distributed nationwide in the U.S.A., as well as in Australia and Canada. The recall covers three specific vials: two 5mL vials and one 10mL vial. The affected lots are identified by the following codes and expiration dates: Lot # t02-13-2017@98 (Exp 5/15/2017), Lot # t02-14-2017@98 (Exp 5/16/2017), and Lot # t02-15-2017@120 (Exp 5/17/2017).

Consumers and healthcare providers should check their inventory for these specific lot numbers and expiration dates. If the product matches the recalled lots, it should be discontinued and returned to the pharmacy or manufacturer for disposal or credit, in accordance with standard recall procedures.

The recalled product

Product
FERR GLUC MDV 60MG/ML INJ, Injection, 60mg/mL, Rx only, Packaged in 5mL and 10mL Glass /Multiple Dose vial, Prepared by Key Compounding Pharmacy
Manufacturer
Key Pharmacy and Compounding Center
Category
Drug — Compounded Sterile Drug
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 (6)

  • Lot # t02-13-2017@98
  • Exp 5/15/2017
  • t02-14-2017@98
  • Exp 5/16/2017
  • t02-15-2017@120
  • Exp 5/17/2017

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 →

Related recalls

Same manufacturer · Key Pharmacy and Compounding Center

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Same hazard · sterility

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