Why it was recalled
Lack of Assurance of Sterility: Recall initiated due to FDA observations pertaining to aseptic and GMP practices at the manufacturers site potentially impacting product sterility.
Product description
Atracurium Besylate Injection, USP, 100 mg per 10 mL (10 mg per mL), Rx Only, 10 mL Multi-Dose Vial, For Intravenous Injection, Mfd. for: Sagent Pharmaceuticals, Schaumberg, IL 60195, NDC 25021-672-10
Lot numbers, UPCs & expiration codes
Lot Numbers: VATB012, VATB013, VATB014, Exp 11/15; VATB017, Exp 08/16
Where it was sold
Nationwide and Puerto Rico
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-0399-2015
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Feb 23, 2015
- FDA report date
- Mar 11, 2015
- Quantity
- 140,850 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Sagent Pharmaceuticals Inc
Original FDA data
Every field from FDA enforcement report D-0399-2015, exactly as published.
Show all FDA fields
- City
- Schaumburg
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 70600
- Address
- 1901 N Roselle Rd Ste 700
- Code information
- Lot Numbers: VATB012, VATB013, VATB014, Exp 11/15; VATB017, Exp 08/16
- Postal code
- 60195-3194
- Report date
- Mar 11, 2015
- Product type
- Drugs
- Recall number
- D-0399-2015
- Classification
- Class II
- Recalling firm
- Sagent Pharmaceuticals Inc
- Product quantity
- 140,850 vials
- Termination date
- Jun 22, 2016
- Reason for recall
- Lack of Assurance of Sterility: Recall initiated due to FDA observations pertaining to aseptic and GMP practices at the manufacturers site potentially impacting product sterility.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Atracurium Besylate Injection, USP, 100 mg per 10 mL (10 mg per mL), Rx Only, 10 mL Multi-Dose Vial, For Intravenous Injection, Mfd. for: Sagent Pharmaceuticals, Schaumberg, IL 60195, NDC 25021-672-10
- Distribution pattern
- Nationwide and Puerto Rico
- Recall initiation date
- Feb 23, 2015
- Initial firm notification
- Letter
- Center classification date
- Mar 3, 2015