Why it was recalled
Lack of Assurance of Sterility; leaking of premix bags
Product description
Zoledronic Acid Injection 5 mg per 100 mL (0.05 mg/mL), 100 mL single-use bag packaged in a foil overwrap, Rx only, Sterile, For Intravenous Infusion, Mfd. for Sagent Pharmaceuticals Schaumburg, IL ---- NDC 25021-830-82
Lot numbers, UPCs & expiration codes
NDC 25021-830-82; Lot Numbers and Expiration Dates: Lot 30076, Expires 01/2015; Lot 30077, Expires 01/2015.
Where it was sold
Nationwide
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-1615-2014
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Mar 4, 2014
- FDA report date
- Oct 8, 2014
- Quantity
- 10,622 bags
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Sagent Pharmaceuticals Inc
Original FDA data
Every field from FDA enforcement report D-1615-2014, exactly as published.
Show all FDA fields
- City
- Schaumburg
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 67689
- Address
- 1901 N Roselle Rd Ste 700
- Code information
- NDC 25021-830-82; Lot Numbers and Expiration Dates: Lot 30076, Expires 01/2015; Lot 30077, Expires 01/2015.
- Postal code
- 60195-3194
- Report date
- Oct 8, 2014
- Product type
- Drugs
- Recall number
- D-1615-2014
- Classification
- Class II
- Recalling firm
- Sagent Pharmaceuticals Inc
- Product quantity
- 10,622 bags
- Termination date
- Jul 7, 2016
- Reason for recall
- Lack of Assurance of Sterility; leaking of premix bags
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Zoledronic Acid Injection 5 mg per 100 mL (0.05 mg/mL), 100 mL single-use bag packaged in a foil overwrap, Rx only, Sterile, For Intravenous Infusion, Mfd. for Sagent Pharmaceuticals Schaumburg, IL ---- NDC 25021-830-82
- Distribution pattern
- Nationwide
- Recall initiation date
- Mar 4, 2014
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Center classification date
- Sep 29, 2014