The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0765-2017·Announced 2017-05-24

Key Pharmacy Recalls Sterile Compounded Glutathione Inhalation Solution

Key Pharmacy and Compounding Center is recalling sterile compounded glutathione inhalation solution due to 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 recall is classified as FDA Class II. According to the rubric, FDA Class II recalls involving significant injury or property damage reports, or in this context, a critical sterility failure in a sterile compounded drug, align with a Severe rating (Score 4).

Plain-English summary

Key Pharmacy and Compounding Center is recalling sterile compounded drugs, specifically Glutathione Inhalation Solution, 200mg/mL, 4mL Plastic/Multiple Dose vial. The recall is being conducted because the firm lacks assurance of the sterility of the product.

The affected product is Lot # 02-20-2017@8 with an expiration date of 4/21/2017. The product was distributed nationwide in the U.S.A., Australia, and Canada.

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

The recalled product

Product
GLUTATHIONE INH *PV* 200MG/ML SOLN, Inhalation Solution, 200mg/mL, Rx only, 4mL Plastic/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 (2)

  • Lot # 02-20-2017@8
  • Exp 4/21/2017.

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

See all →

Same hazard · sterility failure

See all →

Similar recalls