The Recall Desk
LowFDA (Drugs)·D-0103-2019·Announced 2018-10-03

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

Dr. Reddy's Laboratories is recalling Zoledronic Acid Injection vials because they failed impurity specifications with 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 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

Dr. Reddy's Laboratories, Inc. is recalling 59,468 vials of Zoledronic Acid Injection, 5mg/100 mL (0.05 mg/mL) 100ml vial. The product is a prescription-only medication manufactured by Gland Pharma Limited in India for Dr. Reddy's Laboratories Limited. The recall is due to the product failing impurities and degradation specifications, specifically showing out-of-specification (OOS) results for unknown impurities.

The affected product was distributed to retailers, distributors, physician offices, and medical facilities throughout the United States. The recall covers specific batch numbers with expiration dates ranging from September 2018 to March 2020, including batches BS633, BS701 through BS715, BS726 through BS730, and BS801.

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. Healthcare providers and patients should stop using the affected vials and contact their pharmacy or Dr. Reddy's Laboratories for further instructions.

The recalled product

Product
ZOLEDRONIC ACID (ZOLEDRONIC ACID)
Brand
ZOLEDRONIC ACID
Manufacturer
Dr. Reddy's Laboratories, Inc.
Category
Drug — Injection
Hazard
Affected units
59,468

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 (20)

  • Batch Numbers: BS633
  • EXP 9/2018
  • BS701
  • BS702
  • BS703
  • EXP 12/2018
  • BS708
  • BS709
  • BS711
  • BS712
  • BS713
  • BS714
  • BS715
  • EXP 3/2019
  • BS726
  • BS727
  • EXP 6/2019
  • BS728
  • BS729
  • BS730

UPCs (1)

  • 0355111688525

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 →

Related recalls

Same brand · ZOLEDRONIC ACID

Same manufacturer · Dr. Reddy's Laboratories, Inc.

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Same hazard · unknown impurities

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