The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0786-2017·Announced 2017-05-24

Key Pharmacy Recalls Vitamin D3 Injection Due to Sterility Concerns

Key Pharmacy and Compounding Center is recalling specific lots of Vitamin D3 in Olive Oil Injection due to a lack of assurance of sterility.

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, which corresponds to a Severe severity score under the rubric for significant injury or property damage reports or high-risk scenarios.

Plain-English summary

Key Pharmacy and Compounding Center is recalling specific lots of Vitamin D3 in Olive Oil SDV 100,000U/ML Injection. The product is a prescription-only medication packaged in 2mL glass single-dose vials. The recall is being conducted because the firm cannot assure the sterility of the compounded drugs within their expiration dates.

The affected product includes two specific lots: Lot # t01-31-2017@119 with an expiration date of 5/2/2017, and Lot # t02-01-2017@130 with an expiration date of 5/4/2017. The quantity involved is 5/2 mL vials. These 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 expiration dates. If the product is found, it should be discontinued and returned to the pharmacy or manufacturer for further instructions.

The recalled product

Product
VITAMIN D3 IN OLIVE OIL SDV 100,000U/ML INJ, Injection, 150,000u/mL, Rx only, packaged in 2mL Glass/Single Dose vial, 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 # t01-31-2017@119
  • Exp 5/2/2017
  • t02-01-2017@130
  • Exp 5/4/2017

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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