Fresenius Kabi Recalls Gentamicin Vials Due to Missing Stoppers
Fresenius Kabi is recalling 92,125 vials of Gentamicin Injection because some may be missing stoppers. The product was distributed nationwide and in Puerto Rico.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a defective container (missing stoppers) which is a packaging/integrity issue without reported injuries or illnesses.
Plain-English summary
Fresenius Kabi USA, LLC is recalling 92,125 vials of Gentamicin Injection, USP, 40 mg/mL, 20 mL Multiple Dose Vial. The recall is due to a defect where vials may be missing stoppers. The product is manufactured by APP Pharmaceuticals, LLC, and carries the NDC 63323-010-20.
The affected product is identified by Product Code 1020, Lot Number 6107992, and an expiration date of 09/2015. The recall covers distribution across the United States and Puerto Rico.
Consumers and healthcare providers should check their inventory for this specific lot and stopper status. If the product is found, it should be returned to the supplier or the recalling firm.
The recalled product
- Product
- GENTAMICIN (GENTAMICIN SULFATE)
- Brand
- GENTAMICIN
- Manufacturer
- Fresenius Kabi USA, LLC
- Category
- Drug — Antibiotic Injection
- Affected units
- 92,125
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)
- Product Code: 1020
- NDC: 63323-010-20
- Lot Number: 6107992
- Expiration Date: 09/2015
UPCs (2)
- 0363323010034
- 0363323010010
Distribution
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