Haloperidol Decanoate Injection recall: Impurity Out of Spec
HALOPERIDOL DECANOATE INJECTION, 50 mg/mL, 1 mL vial, Rx only, Fresenius Kabi USA, LLC, Schaumburg, IL 60173 NDC 63323-469-01
Why was Haloperidol Decanoate Injection recalled?
Failed Impurities/Degradation Specifications: Fresenius Kabi is recalling three lots of Haloperidol Decanoate Injection due to an 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 6105149, Exp.05/14; 6105696, Exp. 07/14; 6105836, Exp. 08/14; Lot 6106516, Exp. 12/14; Lot 6106837, Exp. 02/15
- Product
- HALOPERIDOL DECANOATE INJECTION, 50 mg/mL, 1 mL vial, Rx only, Fresenius Kabi USA, LLC, Schaumburg, IL 60173 NDC 63323-469-01
- Recalling firm
- Fresenius Kabi USA LLC
- Quantity
- 216,517 vials
- Distribution
- Nationwide and Puerto Rico
- Recall date
- November 19, 2014
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (drug)