The Recall Desk
HighFDA (Drugs)·D-0723-2017·Announced 2017-05-24

Key Pharmacy Recalls Hydroxo-B12 Inhalation Solution Due to Sterility Concerns

Key Pharmacy and Compounding Center is recalling Hydroxo-B12 inhalation solution because the firm cannot assure the sterility of the product.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a sterile compounded drug with a lack of assurance of sterility, which poses a risk of harm (infection) even though no injuries or illnesses have been reported yet, fitting the High severity criteria for risk-of-harm products without reported injury.

Plain-English summary

Key Pharmacy and Compounding Center is recalling a specific lot of Hydroxo-B12 inhalation solution. The product is a prescription-only, 5 mg/mL sterile compounded drug prepared in 5 mL glass multiple-dose vials. The recall is limited to Lot # 02-01-2017@38, which has an expiration date of 4/30/2017.

The recall was initiated due to a lack of assurance of sterility. The firm is recalling sterile compounded drugs within their expiry date because it cannot guarantee that the product remains sterile. The source text does not report any specific illnesses, injuries, or deaths associated with this recall.

The affected product was distributed nationwide in the U.S.A., as well as in Australia and Canada. Patients who have this specific lot of medication should contact their healthcare provider or pharmacist for guidance on how to proceed.

The recalled product

Product
HYDROXO-B12 INH PF GV 5MG/ML SOLN, Inhalation Solution, 5mg/mL, Rx only, 5 mL 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 (2)

  • Lot # 02-01-2017@38
  • Exp 4/30/2017

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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Same manufacturer · Key Pharmacy and Compounding Center

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Same hazard · sterility failure

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