Recalls / Class III
Class IIID-0103-2019
Product
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 name
- Zoledronic Acid
- Generic name
- Zoledronic Acid
- Active ingredient
- Zoledronic Acid
- Route
- Intravenous
- NDC
- 55111-688
- FDA application
- ANDA091363
- Affected 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..
Why it was recalled
Failed Impurities/Degradation Specifications: OOS for unknown impurities.
Recalling firm
- Firm
- Dr. Reddy's Laboratories, Inc.
- Manufacturer
- Dr.Reddy's Laboratories Ltd
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 107 College Rd E, Princeton, New Jersey 08540-6623
Distribution
- Quantity
- 59,468 vials
- Distribution pattern
- Product was distributed to retailers, distributors, physician officers and medical facilities throughout the United States.
Timeline
- Recall initiated
- 2018-09-12
- FDA classified
- 2018-10-26
- Posted by FDA
- 2018-10-03
- Terminated
- 2020-03-03
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0103-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.