The Recall Desk
LowFDA (Drugs)·D-0104-2019·Announced 2018-10-03

Dr. Reddy's Recalls Zoledronic Acid Injection Due to Unknown Impurities

Dr. Reddy's Laboratories is recalling 10,530 vials of Zoledronic Acid Injection because of out-of-specification unknown impurities.

What this means for you

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

Our severity reasoning: The FDA classified this recall as Class III, 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

Dr. Reddy's Laboratories, Inc. is recalling 10,530 vials of Zoledronic Acid Injection, 5 mg/100 mL (0.05 mg/mL), One 100ml Single-Dose Bottle. The product is a prescription-only intravenous medication manufactured by Gland Pharma Limited in India for Dr. Reddy's Laboratories Limited. The recall is due to failed impurities and degradation specifications, specifically out-of-specification (OOS) results for unknown impurities.

The affected product is identified by NDC 43598-331-11. The specific batch numbers involved are BS704 (expiration 12/2018), BS725 (expiration 6/2019), and BS745 (expiration 11/2019). The product was distributed to retailers, distributors, physician offices, and medical facilities throughout the United States.

The FDA has classified this recall as Class III, which indicates that use of or exposure to the violative product is not likely to cause adverse health consequences. Patients and healthcare providers should check their inventory for the specific batch numbers listed above and contact Dr. Reddy's Laboratories for further instructions on returning the product.

The recalled product

Product
ZOLEDRONIC ACID (ZOLEDRONIC ACID)
Brand
ZOLEDRONIC ACID
Manufacturer
Dr. Reddy's Laboratories, Inc.
Category
Drug — Prescription Injection
Hazard
Affected units
10,530

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 (6)

  • Batch Numbers: BS704
  • EXP 12/018
  • BS725
  • EXP 6/2019
  • BS745
  • EXP 11/2019.

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 2 recalled by Dr. Reddy's Laboratories, Inc. 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 2 products in this recall →

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Same brand · ZOLEDRONIC ACID

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Same hazard · unknown impurities

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