Sagent Recalls Zoledronic Acid Injection Due to Sterility Concerns
Sagent Pharmaceuticals is recalling 10,622 bags of Zoledronic Acid Injection because of a lack of assurance of sterility and leaking premix bags.
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 and involves a lack of assurance of sterility in an intravenous drug, which poses a significant risk of serious injury or infection.
Plain-English summary
Sagent Pharmaceuticals Inc is recalling 10,622 bags of Zoledronic Acid Injection 5 mg per 100 mL (0.05 mg/mL). The product is a sterile, single-use bag intended for intravenous infusion and is packaged in a foil overwrap. The recall is being conducted due to a lack of assurance of sterility and the leaking of premix bags.
The affected product is identified by NDC 25021-830-82. The specific lots involved are Lot 30076 and Lot 30077, both with an expiration date of 01/2015. The recall is classified as Class II by the FDA, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The product was distributed nationwide. Healthcare providers and patients should stop using the affected lots and contact Sagent Pharmaceuticals or their local FDA office for further instructions on how to return the product.
The recalled product
- Product
- ZOLEDRONIC ACID (ZOLEDRONIC ACID)
- Brand
- ZOLEDRONIC ACID
- Manufacturer
- Sagent Pharmaceuticals Inc
- Category
- Drug — Antineoplastic
- Affected units
- 10,622
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 (5)
- NDC 25021-830-82
- Lot Numbers and Expiration Dates: Lot 30076
- Expires 01/2015
- Lot 30077
- Expires 01/2015.
Distribution
Distributed nationwide across the United States.
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