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