The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0721-2017·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 classified this as an FDA Class II recall. According to the rubric, FDA Class II recalls involving significant risks such as sterility failures in injectable drugs are categorized as Severe.

Plain-English summary

Key Pharmacy and Compounding Center is recalling 50 vials of HYDROXO-B12 *1ML* SDV 1MG/ML INJ. The affected product is a prescription-only injection prepared in 1 mL glass single-dose vials. The recall covers two specific lots: t01-16-2017@91 (expiring 4/17/2017) and t02-08-2017@93 (expiring 4/30/2017).

The recall was initiated due to a lack of assurance of sterility. The firm is recalling these sterile compounded drugs while they are still within their expiration dates to address this quality control issue.

The affected vials were distributed nationwide in the United States, as well as in Australia and Canada. Consumers and healthcare providers should stop using the affected lots and contact their healthcare provider or the recalling firm for further instructions.

The recalled product

Product
HYDROXO-B12 *1ML* SDV 1MG/ML INJ, Injection, 1mg/mL, Rx only, 1 mL Glass/Single Dose vial, Prepared by Key Compounding Pharmacy
Manufacturer
Key Pharmacy and Compounding Center
Category
Drug — Compounded Injectable
Hazard
Affected units
50

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 (4)

  • Lot # t01-16-2017@91
  • Exp 4/17/2017
  • t02-08-2017@93
  • 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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