The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0726-2017·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 recall is classified as FDA Class II, and the hazard involves a lack of assurance of sterility in an injectable drug, which poses a significant risk of serious injury or hospitalization if contaminated.

Plain-English summary

Key Pharmacy and Compounding Center is recalling specific lots of Hydroxo-B12 30ml PBF MDV (Calif) 1mg/mL injections. The recall involves 2 vials of the prescription-only medication prepared by the firm. The affected lots are identified by the codes t02-06-2017@102 and t02-16-2017@106, both 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 within their expiration dates because it cannot guarantee that the products are free from microbial contamination.

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 these specific lot numbers and stop using the product if it matches the recalled description.

The recalled product

Product
HYDROXO-B12 30ML PBF MDV (CALIF) 1MG/ML INJ, Injection, 1mg/mL, Rx only, 30 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
Manufacturer
Key Pharmacy and Compounding Center
Category
Drug — Compounded Injectable
Hazard
Affected units
2

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 # t02-06-2017@102
  • Exp 4/30/2017
  • t02-16-2017@106
  • 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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