Agency classClass IIOur severity:Severe FDA (Drugs)·D-0456-2017·Announced 2017-02-08

Fresenius Kabi Recalls Midazolam Injection Due to Impurities

Fresenius Kabi is recalling specific lots of Midazolam Injection because they failed impurities and degradation specifications.

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 agency classification is FDA Class II, which corresponds to a Severe rating under the rubric for drug recalls involving potential health risks.

Plain-English summary

Fresenius Kabi USA, LLC is recalling 47,020 vials of Midazolam Injection, USP, 25 mg/5 mL (5 mg/mL). The affected product is packaged in 5 mL vials, 10 vials per carton, and is available by prescription only. The specific lots involved are 6007327 and 6007329, both with an expiration date of 01-2017.

The recall was initiated because the product failed impurities and degradation specifications. This indicates that the medication did not meet the required quality standards for chemical purity and stability.

The affected product was distributed nationwide and in Puerto Rico. Healthcare providers and patients should check their inventory for these specific lot numbers and expiration dates. If found, the product should be quarantined and not administered until further notice.

The recalled product

Product: MIDAZOLAM (MIDAZOLAM HYDROCHLORIDE)
Brand: MIDAZOLAM
Manufacturer: Fresenius Kabi USA, LLC
Category: Drug — Injection
Hazard: impurities
degradation

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 (3)

Lot 6007327
exp. 01-2017
Lot 6007329

UPCs (7)

0363323411183
0363323411138
0363323412135
0363323411220
0363323412180
0363323412036
0363323411152

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Same brand · MIDAZOLAM

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