The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0766-2017·Announced 2017-05-24

Key Pharmacy Recalls GSH/NAC Inhalation Solution Due to Sterility Concerns

Key Pharmacy and Compounding Center is recalling GSH/NAC inhalation solution because the firm cannot assure the product is 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 source text explicitly identifies the agency classification as Class II. According to the severity rubric, an FDA Class II recall involving a sterile compounded drug where sterility is not assured falls under the 'Severe' category (Score 4), as it implies a risk of significant injury or hospitalization potential, even if specific injury reports are not detailed in the provided text.

Plain-English summary

Key Pharmacy and Compounding Center is recalling GSH/NAC INH 2ML PV 60/100MG/ML SOLN, an inhalation solution, due to a lack of assurance of sterility. The recalled product is a prescription-only sterile compounded drug prepared in 5mL plastic single-dose vials. The specific lot affected is # t02-20-2017@75, which has an expiration date of 4/22/2017.

The recall was initiated because the firm could not guarantee that the sterile compounded drugs were free from contamination. The product was distributed nationwide in the U.S.A., as well as in Australia and Canada.

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

The recalled product

Product
GSH/NAC INH 2ML PV 60/100MG/ML SOLN, Inhalation Solution, 60mg/100mg/mL, Rx only, 5mL Plastic/Single 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 # t02-20-2017@75
  • Exp 4/22/2017.

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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