The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0716-2017·Announced 2017-05-24

FDA Recalls Key Pharmacy Compounded Ferric Gluconate Injection for Sterility Concerns

Key Pharmacy and Compounding Center is recalling a specific lot of compounded ferric gluconate injection due to a lack of assurance of 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 source text identifies this as an FDA Class II recall. According to the severity rubric, an FDA Class II recall is classified as Severe (Score 4), particularly when involving sterile compounded drugs where sterility assurance is compromised.

Plain-English summary

The U.S. Food and Drug Administration (FDA) has issued a Class II recall for a compounded sterile drug product. The product is FERR GLUC/PROCAINE 10ML MDV 60/10MG/ML INJ, an injection containing 60mg/10mg/mL, prepared by Key Pharmacy and Compounding Center. The recall is limited to Lot # t01-23-2017@83, which has an expiration date of 5/24/2017.

The recall was initiated because the firm lacks assurance of the sterility of the compounded drug. The product is a prescription-only, 10 mL glass multiple-dose vial. According to the source text, the product was distributed nationwide in the U.S.A., as well as in Australia and Canada.

Patients and healthcare providers who have this specific lot of the medication should stop using it and contact their healthcare provider or the recalling firm for further instructions. The FDA classifies this as a Class II recall, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
FERR GLUC/PROCAINE 10ML MDV 60/10MG/ML INJ, Injection, 60mg/10mg/mL, Rx only, 10 mL glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
Manufacturer
Key Pharmacy and Compounding Center
Category
Drug — Compounded Sterile Drug
Hazard
Affected units
1

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 # t01-23-2017@83
  • Exp 5/24/2017

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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