The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0728-2017·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 guarantee 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. According to the rubric, an FDA Class II recall involving a sterile drug with a lack of sterility assurance falls under the 'Severe' category (score 4), as it represents a significant risk of infection or injury.

Plain-English summary

Key Pharmacy and Compounding Center is recalling a specific lot of Hydroxo-B12 5mL multiple-dose vials. The product is a prescription-only injection containing 10mg/mL of Hydroxo-B12. The affected lot is identified as Lot # t02-15-2017@111 with an expiration date of 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 date to address this quality concern.

The affected products were distributed nationwide in the U.S.A., as well as in Australia and Canada. Consumers and healthcare providers should check their inventory for this specific lot number and expiration date. If the product matches the recalled lot, it should not be used.

The recalled product

Product
HYDROXO-B12 5ML PBF MDV (CALIF) 10MG/ML INJ, Injection, 10mg/mL, RX only, 5mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
Manufacturer
Key Pharmacy and Compounding Center
Category
Drug — Compounded Sterile Drug
Hazard
Affected units
1

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 # t02-15-2017@111
  • 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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