FDAFDA · Food and drugs·Recall number D-0103-2019
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
Published October 3, 2018 · Recall initiated: September 12, 2018
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Impurities/Degradation Specifications: OOS for unknown impurities.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- ZOLEDRONIC ACID
- Manufacturer
- Dr. Reddy's Laboratories, Inc.
- Distributor
- Product was distributed to retailers, distributors, physician officers and medical facilities throughout the United States.
- UPC
- 0355111688525
- Lot
- 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..
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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