The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0761-2017·Announced 2017-05-24

Key Pharmacy Recalls Cyanocobalamin Injections Due to Sterility Concerns

Key Pharmacy and Compounding Center is recalling specific lots of Cyanocobalamin 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 recall is classified as FDA Class II and involves a lack of assurance of sterility in an injectable drug, which poses a significant risk of infection or serious injury, meeting the criteria for a Severe rating.

Plain-English summary

Key Pharmacy and Compounding Center is recalling Cyanocobalamin 10mL Multiple Dose Vials (1mg/mL) prepared by the firm. The recall affects 2 vials per lot, specifically Lot # t02-13-2017@99 with an expiration date of 5/15/2017. These prescription-only injections 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 sterile compounded drugs within their expiry date because it cannot guarantee that the products remain sterile. This classification is designated as Class II by the FDA.

Consumers and healthcare providers should stop using the affected product immediately. Patients who have received this medication should consult their healthcare provider for guidance. The recall is limited to the specific lot number and expiration date listed above.

The recalled product

Product
CYANOCOBALAMIN 10ML MDV 1MG/ML INJ, Injection, 1mg/mL, Rx only, 10mL 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 (2)

  • Lot # t02-13-2017@99
  • Exp 5/15/2017

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 →

Related recalls

Same manufacturer · Key Pharmacy and Compounding Center

See all →

Same hazard · sterility

See all →

Similar recalls