Sagent Recalls Fluconazole Injection Due to Cross-Contamination with Metronidazole
Sagent Pharmaceuticals is recalling specific lots of Fluconazole Injection due to cross-contamination with metronidazole. The affected product is 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 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 recall is classified as FDA Class II. Per the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when involving potential adverse health consequences from contamination.
Plain-English summary
Sagent Pharmaceuticals Inc is recalling 37,450 bags of Fluconazole Injection, USP (in 0.9% Sodium Chloride), 200 mg per 100 ml, Single-Dose Container Bag. The recall is being conducted because of cross-contamination with metronidazole. The affected product is identified by Lot # 40608 and has an expiration date of 5/17.
The recalled product was distributed nationwide and in Puerto Rico. The agency has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
Healthcare providers and patients should stop using the affected lots of Fluconazole Injection and contact Sagent Pharmaceuticals or their local FDA office for further instructions on how to return or dispose of the product.
The recalled product
- Product
- Fluconazole Injection, USP (in 0.9% Sodium Chloride), 200 mg per 100 ml, Single-Dose Container Bag, Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195, NDC 25021-0113-82
- Manufacturer
- Sagent Pharmaceuticals Inc
- Category
- Drug — Antifungal Injection
- Affected units
- 37,450
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 #: 40608
- Exp 5/17
Distribution
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