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Class III: unlikely to cause harmTerminated

Fresenius Kabi Haloperidol Decanoate Injection Recall

Haloperidol Decanoate Injection, 50 mg/mL, 1 mL vial, Rx Only

Fresenius Kabi USA, LLC · Lake Zurich, IL

Risk level
Class III
Reported by FDA
Apr 20, 2016
Recall ID
D-0818-2016
Check your lot numberHow we source this data

Summary

Fresenius Kabi recalled Haloperidol Decanoate Injection starting Apr 7, 2016. The FDA classified it as Class III (unlikely to cause harm) and published enforcement report D-0818-2016 on Apr 20, 2016. Reason: Failed Impurities/Degradation Specifications: Firm is recalling product due to an impurity out-of-specification result. Status: Terminated.

Why it was recalled

Failed Impurities/Degradation Specifications: Firm is recalling product due to an impurity out-of-specification result.

Product description

Haloperidol Decanoate Injection, 50 mg/mL, 1 mL vial, Rx Only. Fresenius Kabi USA LLC, Lake Zurich, IL 60047, NDC 63323-469-01.

Lot numbers, UPCs & expiration codes

Lot #: 6111080, Exp. 01/2017

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-0818-2016
Classification
Class III
Status
Terminated
Recall initiated
Apr 7, 2016
FDA report date
Apr 20, 2016
Quantity
48,210 units
Recall type
Voluntary: Firm initiated
Recalling firm
Fresenius Kabi USA, LLC

Original FDA data

Every field from FDA enforcement report D-0818-2016, exactly as published.

Show all FDA fields
City
Lake Zurich
State
IL
Status
Terminated
Country
United States
Event ID
73652
Address
3 Corporate Dr
Code information
Lot #: 6111080, Exp. 01/2017
Postal code
60047-8930
Report date
Apr 20, 2016
Product type
Drugs
Recall number
D-0818-2016
Classification
Class III
Recalling firm
Fresenius Kabi USA, LLC
Product quantity
48,210 units
Termination date
Nov 7, 2016
Reason for recall
Failed Impurities/Degradation Specifications: Firm is recalling product due to an impurity 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, Lake Zurich, IL 60047, NDC 63323-469-01.
Distribution pattern
Nationwide and Puerto Rico
Recall initiation date
Apr 7, 2016
Initial firm notification
Letter
Center classification date
Apr 11, 2016

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0818-2016, published Apr 20, 2016. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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