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, 50 mg per 5 mL (10 mg per mL), Rx Only, 5 mL Single-Dose Vial, For Intravenous Injection, Mfd. for: Sagent Pharmaceuticals, Schaumberg, IL 60195, NDC 25021-659-05
Lot numbers, UPCs & expiration codes
Lot Numbers: VATA012, Exp 11/15; VATA015, 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-0398-2015
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Feb 23, 2015
- FDA report date
- Mar 11, 2015
- Quantity
- 140,720 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Sagent Pharmaceuticals Inc
Original FDA data
Every field from FDA enforcement report D-0398-2015, 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: VATA012, Exp 11/15; VATA015, Exp 08/16
- Postal code
- 60195-3194
- Report date
- Mar 11, 2015
- Product type
- Drugs
- Recall number
- D-0398-2015
- Classification
- Class II
- Recalling firm
- Sagent Pharmaceuticals Inc
- Product quantity
- 140,720 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, 50 mg per 5 mL (10 mg per mL), Rx Only, 5 mL Single-Dose Vial, For Intravenous Injection, Mfd. for: Sagent Pharmaceuticals, Schaumberg, IL 60195, NDC 25021-659-05
- Distribution pattern
- Nationwide and Puerto Rico
- Recall initiation date
- Feb 23, 2015
- Initial firm notification
- Letter
- Center classification date
- Mar 3, 2015