Why it was recalled
Failed Impuities/Degradation Specifications
Product description
OCTREOTIDE ACETATE INJECTION, 50 mcg (base)/mL (0.05 mg/mL), 1 mL Single Dose Vial, Rx only, Manufactured by Fresenius Kabi USA, LLC, Schaumburg, IL 60173, NDC 63323-365-01.
Lot numbers, UPCs & expiration codes
Lot # 6108322; Exp. 04/16 Lot # 6108824; Exp. 07/16
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-0866-2016
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- May 4, 2016
- FDA report date
- Jun 1, 2016
- Quantity
- 355,150 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Fresenius Kabi USA, LLC
Original FDA data
Every field from FDA enforcement report D-0866-2016, exactly as published.
Show all FDA fields
- City
- Lake Zurich
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 73811
- Address
- 3 Corporate Dr
- Code information
- Lot # 6108322; Exp. 04/16 Lot # 6108824; Exp. 07/16
- Postal code
- 60047-8930
- Report date
- Jun 1, 2016
- Product type
- Drugs
- Recall number
- D-0866-2016
- Classification
- Class II
- Recalling firm
- Fresenius Kabi USA, LLC
- Product quantity
- 355,150 vials
- Termination date
- Jan 23, 2017
- Reason for recall
- Failed Impuities/Degradation Specifications
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- OCTREOTIDE ACETATE INJECTION, 50 mcg (base)/mL (0.05 mg/mL), 1 mL Single Dose Vial, Rx only, Manufactured by Fresenius Kabi USA, LLC, Schaumburg, IL 60173, NDC 63323-365-01.
- Distribution pattern
- Nationwide and Puerto Rico.
- Recall initiation date
- May 4, 2016
- Initial firm notification
- Letter
- Center classification date
- May 24, 2016