Hospira Recalls Ondansetron Injection Vials Due to Glass Spicules
Hospira Inc. is recalling 681,400 vials of Ondansetron Injection because glass spicules were found during a site inspection.
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, and the presence of glass spicules in an injectable drug poses a significant risk of injury, meeting the criteria for a Severe rating.
Plain-English summary
Hospira Inc. is recalling 681,400 vials of Ondansetron Injection, USP, 4 mg/2 mL (2 mg/mL), 2 mL Single-dose Vial. The product is a prescription-only sterile injection intended for intramuscular or intravenous use. The recall affects NDC 0409-4755-03 with lot numbers 29-484-DK* and 29-510-DK*, which have an expiration date of 05/01/2015. The lot numbers may be preceded by an 01.
The recall was initiated due to the presence of particular matter, specifically glass spicules (glass strands), which were identified during a site inspection of the vials. This is a potential vendor glass issue.
The affected product was distributed nationwide and in Puerto Rico. Consumers and healthcare providers should stop using the recalled vials and contact their pharmacist or the recalling firm for further instructions.
The recalled product
- Product
- ONDANSETRON (ONDANSETRON)
- Brand
- ONDANSETRON
- Manufacturer
- Hospira Inc.
- Category
- Drug — Injectable
- Affected units
- 681,400
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
UPCs (1)
- 040947550329
Distribution
Part of a larger recall action
This product is one of 2 recalled by Hospira Inc. 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 2 products in this recall →Related recalls
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