Dr. Reddy's Laboratories, Inc.: Zoledronic Acid Injection, 5mg/100 mL (0.05 mg/mL) 100ml vial, Rx Only. Mfd By: Gland Pharma Limited D.P. Pally - 500 043 India: Mfd. For: Dr. Reddy's Laboratories Limi

Is my product affected?

Zoledronic Acid Injection, 5mg/100 mL (0.05 mg/mL) 100ml vial, Rx Only. Mfd By: Gland Pharma Limited D.P. Pally - 500 043 India: Mfd. For: Dr. Reddy's Laboratories Limited Bachupally - 500 090 India. NDC 55111-688-52

• Brand ZOLEDRONIC ACID

Check against the official notice below — it lists the full affected range.

What happened

Dr. Reddy's Laboratories is recalling Zoledronic Acid Injection, 5mg/100 mL, manufactured by Gland Pharma Limited in India. The recall affects 59,468 vials distributed throughout the United States to retailers, distributors, physician offices, and medical facilities. The product is being recalled because it failed impurities and degradation specifications due to the presence of unknown impurities.

The affected batches include multiple lot numbers with expiration dates ranging from September 2018 through March 2020 (Batch Numbers: BS633, BS701, BS702, BS703, BS708, BS709, BS711, BS712, BS713, BS714, BS715, BS726, BS727, BS728, BS729, BS730, and BS801). The source document does not specify a remedy or recommended action for consumers or healthcare providers.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

Failed Impurities/Degradation Specifications: OOS for unknown impurities.

Details from the source

Reason for recall: Failed Impurities/Degradation Specifications: OOS for unknown impurities. Distribution: Product was distributed to retailers, distributors, physician officers and medical facilities throughout the United States. Quantity: 59,468 vials Lot/code info: 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, EXP 7/2019; BS801, EXP 03/2020..

Source

Official record: FDA (Drug enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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