Baxter Recalls Famotidine Injection Due to Plastic and Rubber Particulate Matter
Baxter Healthcare is recalling 19,152 containers of Famotidine Injection 20 mg due to a complaint reporting the presence of plastic and rubber particulate matter.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (injection containing foreign particulate matter) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Baxter Healthcare Corporation is recalling 19,152 containers of Famotidine Injection 20 mg, a prescription-only intravenous medication. The product is packaged in Galaxy Single Dose Containers with NDC 0338-5197-41. The specific lot affected is NC082768, which has an expiration date of 12/23/2014.
The recall was initiated after Baxter received a complaint reporting the presence of particulate matter in the premixed containers. The particulate matter was identified as plastic or rubber. The affected product was distributed nationwide.
Healthcare providers and patients should stop using the affected lot of Famotidine Injection. Baxter Healthcare is the recalling firm responsible for this action.
The recalled product
- Product
- FAMOTIDINE (FAMOTIDINE)
- Brand
- FAMOTIDINE
- Manufacturer
- Baxter Healthcare Corp.
- Category
- Drug — Prescription Drug
- Affected units
- 19,152
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 #: NC082768
- Exp 12/23/2014
Distribution
Distributed nationwide across the United States.
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