The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0775-2017·Announced 2017-05-24

FDA Recalls Compounded Progesterone Injection Due to Sterility Concerns

Key Pharmacy and Compounding Center is recalling compounded progesterone injections because the firm cannot ensure the products are sterile.

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 recall is classified as FDA Class II. According to the severity rubric, an FDA Class II recall involving a sterile drug with a lack of assurance of sterility is categorized as Severe (Score 4), as it carries a risk of significant injury or adverse health consequences.

Plain-English summary

The U.S. Food and Drug Administration (FDA) has issued a Class II recall for compounded progesterone sesame oil injections prepared by Key Pharmacy and Compounding Center. The specific product affected is the 10mL multiple-dose vial containing 100mg/mL progesterone in sesame oil. The recall is limited to Lot 02-14-2017@102, which has an expiration date of May 1, 2017.

The recall was initiated due to a lack of assurance of sterility. The firm is recalling these sterile compounded drugs while they are within their expiration date because it cannot guarantee that the products are free from microbial contamination. This classification indicates that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The affected products were distributed nationwide in the United States, as well as in Australia and Canada. Patients who have received this specific medication should consult their healthcare provider for guidance on next steps and potential alternative treatments.

The recalled product

Product
PROGESTERONE SESAME OIL 10ML MDV 100MG/ML INJ, Injection, 100mg/mL, Rx only, 10mL 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 t# 02-14-2017@102
  • Exp 5/1/2017

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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