Why it was recalled
Failed Impurities/Degradation Specifications: Fresenius Kabi is recalling three lots of Haloperidol Decanoate Injection due to an out-of-specification result.
Product description
HALOPERIDOL DECANOATE INJECTION, 50 mg/mL, 1 mL vial, Rx only, Fresenius Kabi USA, LLC, Schaumburg, IL 60173 NDC 63323-469-01
Lot numbers, UPCs & expiration codes
Lot 6105149, Exp.05/14; 6105696, Exp. 07/14; 6105836, Exp. 08/14; Lot 6106516, Exp. 12/14; Lot 6106837, Exp. 02/15
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-0247-2015
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Apr 14, 2014
- FDA report date
- Nov 19, 2014
- Quantity
- 216,517 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Fresenius Kabi USA LLC
Original FDA data
Every field from FDA enforcement report D-0247-2015, exactly as published.
Show all FDA fields
- City
- Melrose Park
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 68019
- Address
- 2020 N Ruby St
- Code information
- Lot 6105149, Exp.05/14; 6105696, Exp. 07/14; 6105836, Exp. 08/14; Lot 6106516, Exp. 12/14; Lot 6106837, Exp. 02/15
- Postal code
- 60160-1112
- Report date
- Nov 19, 2014
- Product type
- Drugs
- Recall number
- D-0247-2015
- Classification
- Class III
- Recalling firm
- Fresenius Kabi USA LLC
- Product quantity
- 216,517 vials
- Termination date
- Mar 8, 2016
- Reason for recall
- Failed Impurities/Degradation Specifications: Fresenius Kabi is recalling three lots of Haloperidol Decanoate Injection due to an out-of-specification result.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- HALOPERIDOL DECANOATE INJECTION, 50 mg/mL, 1 mL vial, Rx only, Fresenius Kabi USA, LLC, Schaumburg, IL 60173 NDC 63323-469-01
- Distribution pattern
- Nationwide and Puerto Rico
- Recall initiation date
- Apr 14, 2014
- Initial firm notification
- Letter
- Center classification date
- Nov 13, 2014