The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1615-2014·Announced 2014-10-08

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.

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 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
Hazard
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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