The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0724-2017·Announced 2017-05-24

Key Pharmacy Recalls Hydroxo-B12 Injections Due to Sterility Concerns

Key Pharmacy and Compounding Center is recalling specific lots of Hydroxo-B12 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 agency classification is FDA Class II. Per the rubric, FDA Class II recalls involving significant risks such as sterility assurance failures in injectable drugs are classified as Severe (Score 4), particularly when structural or process defects in sterile products are involved.

Plain-English summary

Key Pharmacy and Compounding Center is recalling 8 vials of Hydroxo-B12 5mg/mL injection, including 10 mL and 30 mL multiple-dose glass vials. The recall involves three specific lots with expiration dates in April 2017. The products were distributed nationwide in the U.S.A., as well as in Australia and Canada.

The recall was initiated due to a lack of assurance of sterility. The firm is recalling these sterile compounded drugs because it cannot guarantee that the products remain sterile within their expiration dates.

Consumers and healthcare providers should stop using the affected vials immediately. Those who have received or purchased these specific lots should contact their healthcare provider or the recalling firm for further instructions on disposal or replacement.

The recalled product

Product
HYDROXO-B12 10ML PBF MDV 5MG/ML INJ, 5mg/mL, Rx only, 10 mL Glass/ Multiple Dose vial, Prepared by Key Compounding Pharmacy HYDROXO-B12 30ML PBF MDV 5MG/ML INJ, 5mg/mL, RX only, 30 mL Glass/ Multiple Dose vial.
Manufacturer
Key Pharmacy and Compounding Center
Category
Drug — Compounded Injectable
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 (6)

  • Lot # t01-20-2017@87
  • Exp 4/23/2017
  • t02-08-2017@99
  • Exp 4/30/2017
  • t02-21-2017@113
  • 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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