Why it was recalled
Crystallization: Active pharmaceutical ingredient is precipitating in product solution.
Product description
IRINOTECAN HYDROCHLORIDE INJECTION, 40 mg/2 mL (20 mg/mL), 2 mL Single Dose Vial, Rx only, Manufactured for: APP Pharmaceuticals, LLC, Schaumburg, IL 60173, NDC 63323-193-02, UPC 3 63323 19302 7.
Lot numbers, UPCs & expiration codes
Lot #: 872CZ00101, Exp 12/13
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-915-2013
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jan 22, 2013
- FDA report date
- Aug 28, 2013
- Quantity
- 23,672 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Fresenius Kabi USA LLC (FK USA)
Original FDA data
Every field from FDA enforcement report D-915-2013, exactly as published.
Show all FDA fields
- City
- Schaumburg
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 64102
- Address
- 1501 E Woodfield Rd
- Address (line 2)
- Suite 300 East
- Code information
- Lot #: 872CZ00101, Exp 12/13
- Postal code
- 60173-6052
- Report date
- Aug 28, 2013
- Product type
- Drugs
- Recall number
- D-915-2013
- Classification
- Class II
- Recalling firm
- Fresenius Kabi USA LLC (FK USA)
- Product quantity
- 23,672 vials
- Termination date
- May 12, 2015
- Reason for recall
- Crystallization: Active pharmaceutical ingredient is precipitating in product solution.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- IRINOTECAN HYDROCHLORIDE INJECTION, 40 mg/2 mL (20 mg/mL), 2 mL Single Dose Vial, Rx only, Manufactured for: APP Pharmaceuticals, LLC, Schaumburg, IL 60173, NDC 63323-193-02, UPC 3 63323 19302 7.
- Distribution pattern
- Nationwide
- Recall initiation date
- Jan 22, 2013
- Initial firm notification
- Letter
- Center classification date
- Aug 21, 2013