FDA Recalls Ondansetron Injection Vials Due to Sterility Concerns
Fresenius Kabi USA is recalling 184,550 vials of Ondansetron Injection due to potential glass fractures and particles that compromise sterility.
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 potential contamination (glass particles) or structural defects that could lead to significant injury are rated as Severe (4).
Plain-English summary
Fresenius Kabi USA, LLC is recalling 184,550 vials of Ondansetron Injection, USP, 4 mg/2 mL (2 mg/mL). The product is a prescription medication intended for intramuscular or intravenous use. The recall is limited to Lot 6003930 with an expiration date of 04/2014.
The recall was initiated due to a lack of assurance of sterility. Specifically, the glass vials may contain finish fractures and glass particles. The affected product was distributed nationwide in the United States, including Puerto Rico.
Healthcare providers and patients should stop using the affected vials and contact their healthcare provider or the manufacturer for further instructions. The recall is classified as FDA Class II.
The recalled product
- Product
- ONDANSETRON (ONDANSETRON HYDROCHLORIDE)
- Brand
- ONDANSETRON
- Manufacturer
- Fresenius Kabi USA, LLC
- Category
- Drug — Injection
- Hazard
- Affected units
- 184,550
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 6003930
- exp. date 04/2014
UPCs (2)
- 0363323374204
- 0363323373009
Distribution
Part of a larger recall action
This product is one of 3 recalled by Fresenius Kabi USA, LLC 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.
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