The Recall Desk
Agency classClass IIIOur severity:LowFDA (Drugs)·D-1063-2020·Announced 2020-03-04

Breckenridge Recalls Zoledronic Acid Injection Due to Impurity Failures

Breckenridge Pharmaceutical is recalling 900 vials of Zoledronic Acid Injection because stability testing revealed out-of-specification impurities.

The agency’s classification

FDA (Drugs): Class III

Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

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 1/5 (Low).

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The FDA classified this as a Class III recall, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences.

Plain-English summary

Breckenridge Pharmaceutical, Inc. is recalling 900 vials of Zoledronic Acid Injection 5 mg/100 mL. The product is a sterile solution for intravenous infusion, distributed nationwide in the U.S. The specific lots affected are # 5553.044E and # 5553.044F, with an expiration date of 04/30/2021.

The recall was initiated because the product failed impurities and degradation specifications. Out-of-specification results were obtained for impurities during stability testing. The U.S. Food and Drug Administration has classified this recall as Class III, indicating that use of or exposure to the product is not likely to cause adverse health consequences.

Healthcare providers and patients should stop using the affected lots and contact Breckenridge Pharmaceutical for further instructions or returns.

The recalled product

Product
Zoledronic Acid Injection 5 mg/100 mL (0.05 mg/mL), Solution for Intravenous Infusion, Sterile Solution, 100 mL Single - Dose Vial per Carton, Rx Only, Distributed by: Breckenridge Pharmaceutical, Inc., Boca Raton, FL 33487, Manufactured by: Pharmaceutics International, Inc.…
Manufacturer
Breckenridge Pharmaceutical, Inc
Category
Drug — Injectable
Hazard
Affected units
900

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 (3)

  • Lot # 5553.044E
  • 5553.044F
  • Exp. 04/30/2021

Distribution

Distributed nationwide across the United States.

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