The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0725-2017·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 assure the sterility of the compounded drugs.

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, and the hazard involves a lack of assurance of sterility in a compounded drug, which aligns with the rubric criteria for Severe severity involving significant injury risks or Class II classifications with potential for serious harm.

Plain-English summary

Key Pharmacy and Compounding Center is recalling specific lots of Hydroxo-B12 5ML PBF MDV 1MG/ML INJ. The product is a prescription-only injection packaged in 5 mL and 30 mL glass multiple-dose vials. The recall involves a total of 7 vials, consisting of one 5 mL vial and six 30 mL vials.

The recall is being conducted due to a lack of assurance of sterility for the sterile compounded drugs. The affected lots are t01-26-2017@98 with an expiration date of 4/27/2017, and t02-06-2017@108 with an expiration date of 4/30/2017.

The product was distributed nationwide in the U.S.A., as well as in Australia and Canada. Consumers and healthcare providers should stop using the affected vials and contact their pharmacist or the recalling firm for further instructions.

The recalled product

Product
HYDROXO-B12 5ML PBF MDV 1MG/ML INJ, Injection, 1mg/ml, Rx only, packaged in 5 mL Glass/ Multiple Dose and 30 mL Glass/ Multiple Dose vials,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 (4)

  • Lot # t01-26-2017@98
  • Exp 4/27/2017
  • t02-06-2017@108
  • 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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