The Recall Desk
SevereFDA (Drugs)·D-0769-2017·Announced 2017-05-24

Key Pharmacy Recalls Methyl-B12 Injections Due to Sterility Concerns

Key Pharmacy and Compounding Center is recalling 26 vials of Methyl-B12 injection due to a lack of assurance of sterility.

What this means for you

Illness, injury, or structural failure has been reported. 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. According to the rubric, FDA Class II recalls involving significant injury or property damage reports, or structural defects, are rated as Severe. While no specific injuries are reported in the text, the lack of sterility assurance in an injectable drug represents a significant risk of harm, aligning with the Severe classification for Class II recalls with potential for serious harm.

Plain-English summary

Key Pharmacy and Compounding Center is recalling 26 vials of Methyl-B12 5ML MDV (CALIF) 1MG/ML INJ. The product is a prescription-only injection prepared in 5 mL glass multiple-dose vials.

The recall was initiated because the firm lacks assurance of the sterility of the compounded drugs. The affected lots are t02-17-2017@101 and t02-17-2017@88, both with an expiration date of 4/21/2017.

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 product and contact the recalling firm for further instructions.

The recalled product

Product
METHYL-B12 5ML MDV (CALIF) 1MG/ML INJ, Injection, 1mg/mL, Rx only, 5 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
Manufacturer
Key Pharmacy and Compounding Center
Category
Drug — Compounded Injectable
Hazard
Affected units
26

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 # t02-17-2017@101
  • Exp 4/21/2017
  • t02-17-2017@88
  • Exp 4/21/2017.

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

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Same hazard · sterility

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