Haloperidol Decanoate Injection recall: Impurity Out of Spec
Haloperidol Decanoate Injection, 50 mg/mL, 1 mL vial, Rx Only. Fresenius Kabi USA LLC, Lake Zurich, IL 60047, NDC 63323-469-01.
Why was Haloperidol Decanoate Injection recalled?
Failed Impurities/Degradation Specifications: Firm is recalling product due to an impurity out-of-specification result.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot #: 6111080, Exp. 01/2017
- Product
- Haloperidol Decanoate Injection, 50 mg/mL, 1 mL vial, Rx Only. Fresenius Kabi USA LLC, Lake Zurich, IL 60047, NDC 63323-469-01.
- Recalling firm
- Fresenius Kabi USA, LLC
- Quantity
- 48,210 units
- Distribution
- Nationwide and Puerto Rico
- Recall date
- April 20, 2016
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (drug)