Baxter Recalls Metronidazole Injection Bags Due to Cloth Fiber Particulate Matter
Baxter Healthcare Corp. is recalling 334,560 bags of Metronidazole Injection USP due to the presence of a cloth fiber. The product was distributed nationwide and in Puerto Rico.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The FDA classified this recall as Class I, which meets the rubric criteria for a Critical severity score (5).
Plain-English summary
Baxter Healthcare Corp. is recalling 334,560 bags of Metronidazole Injection USP, 500 mg per 100 mL (5 mg/mL), 100mL Sterile Single Dose Container bag. The recall is due to the presence of particulate matter identified as a cloth fiber. The affected product is identified by Lot # P339135 with an expiration date of 08/31/2017. The product is a prescription-only intravenous medication manufactured by Baxter USA.
The affected product was distributed nationwide and in Puerto Rico. The recall is classified as Class I by the FDA, indicating a reasonable probability that use of the product may cause serious adverse health consequences or death. The specific hazard is the presence of a foreign object (cloth fiber) in the sterile injection solution.
Healthcare providers and patients should stop using the affected product immediately. Patients who have received the affected product should contact their healthcare provider for guidance. The recall number is D-0863-2016.
The recalled product
- Product
- METRONIDAZOLE (METRONIDAZOLE)
- Brand
- METRONIDAZOLE
- Manufacturer
- Baxter Healthcare Corp.
- Category
- Drug — Antibiotic Injection
- Affected units
- 334,560
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 #: P339135
- Exp 08/31/2017
Distribution
Part of a larger recall action
This product is one of 4 recalled by Baxter Healthcare Corp. 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 4 products in this recall →Related recalls
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