Why it was recalled
Subpotent Drug; 15-month stability test station
Product description
Oxytocin Injection, USP, (Synthetic), 10 USP Units/mL, for IV Infusion or IM Use, Rx Only, 1 mL vial, APP ) 10 USP Units/mL, 1 mL, APP Pharmaceuticals, LLC Schaumburg, IL, 60173, NDC 63323-012-01.
Lot numbers, UPCs & expiration codes
Lot #: 6003648, Exp. 6/2013
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-804-2013
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jun 24, 2013
- FDA report date
- Jul 24, 2013
- Quantity
- 221,600 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Fresenius Kabi USA, LLC
Original FDA data
Every field from FDA enforcement report D-804-2013, exactly as published.
Show all FDA fields
- City
- Lake Zurich
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 65512
- Address
- 3 Corporate Dr
- Code information
- Lot #: 6003648, Exp. 6/2013
- Postal code
- 60047-8930
- Report date
- Jul 24, 2013
- Product type
- Drugs
- Recall number
- D-804-2013
- Classification
- Class II
- Recalling firm
- Fresenius Kabi USA, LLC
- Product quantity
- 221,600 vials
- Termination date
- Apr 7, 2015
- Reason for recall
- Subpotent Drug; 15-month stability test station
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Oxytocin Injection, USP, (Synthetic), 10 USP Units/mL, for IV Infusion or IM Use, Rx Only, 1 mL vial, APP ) 10 USP Units/mL, 1 mL, APP Pharmaceuticals, LLC Schaumburg, IL, 60173, NDC 63323-012-01.
- Distribution pattern
- Nationwide and Puerto Rico
- Recall initiation date
- Jun 24, 2013
- Initial firm notification
- Letter
- Center classification date
- Jul 17, 2013