The Recall Desk
SevereFDA (Drugs)·D-0784-2017·Announced 2017-05-24

Key Pharmacy Recalls Vitamin B Complex Injections Due to Sterility Concerns

Key Pharmacy and Compounding Center is recalling specific lots of Vitamin B Complex injections because the firm cannot guarantee the products are sterile.

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 health consequences.

Plain-English summary

Key Pharmacy and Compounding Center is recalling 3 vials of Vitamin B Complex 1ML SDV NA INJ, Injection, 100mg/2mg/2mg/2mg/100mg/mL, Rx only, 1mL Glass; Single Dose. The affected product is identified by Lot # t02-03-2017@37 and has an expiration date of 5/7/2017.

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 date to address this quality concern.

The product was distributed nationwide in the U.S.A., Australia, and Canada. Consumers and healthcare providers should check their inventory for this specific lot number and expiration date. If found, the product should not be used and should be returned to the pharmacy or the recalling firm.

The recalled product

Product
VITAMIN B COMPLEX 1ML SDV NA INJ, Injection, 100mg/2mg/2mg/2mg/100mg/mL, Rx only, 1mL Glass; Single Dose, Prepared by Key Compounding Pharmacy
Manufacturer
Key Pharmacy and Compounding Center
Category
Drug — Compounded Injectable
Hazard
Affected units
3

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 # t02-03-2017@37
  • Exp 5/7/2017

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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