Why it was recalled
Failed Impurities/Degradation Specifications: OOS for unknown impurities.
Product description
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
Lot numbers, UPCs & expiration codes
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..
Where it was sold
Product was distributed to retailers, distributors, physician officers and medical facilities throughout the United States.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0103-2019
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Sep 12, 2018
- FDA report date
- Oct 3, 2018
- Quantity
- 59,468 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Dr. Reddy's Laboratories, Inc.
Original FDA data
Every field from FDA enforcement report D-0103-2019, exactly as published.
Show all FDA fields
- City
- Princeton
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 81012
- Address
- 107 College Rd E
- Code information
- 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..
- Postal code
- 08540-6623
- Report date
- Oct 3, 2018
- Product type
- Drugs
- Recall number
- D-0103-2019
- Classification
- Class III
- Recalling firm
- Dr. Reddy's Laboratories, Inc.
- Product quantity
- 59,468 vials
- Termination date
- Mar 3, 2020
- Reason for recall
- Failed Impurities/Degradation Specifications: OOS for unknown impurities.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Product was distributed to retailers, distributors, physician officers and medical facilities throughout the United States.
- Recall initiation date
- Sep 12, 2018
- Initial firm notification
- Letter
- Center classification date
- Oct 26, 2018