FDAClass IIMay 26, 2021

Haloperidol Decanoate Injection recall: Sterility Concern

Haloperidol Decanoate Injection, USP 50 mg/mL, 1 mL Single Dose Vials, Rx Only, Sterile, 10 Vials, Teva Pharmaceuticals, USA, Inc., North Wales, PA…

Why was Haloperidol Decanoate Injection recalled?

Lack of Assurance of Sterility

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 # 31325793C, exp. date 09/2021

Product
Haloperidol Decanoate Injection, USP 50 mg/mL, 1 mL Single Dose Vials, Rx Only, Sterile, 10 Vials, Teva Pharmaceuticals, USA, Inc., North Wales, PA…
Recalling firm
Teva Pharmaceuticals USA
Quantity
3150 vials
Distribution
Product was distributed nationwide.
Recall date
May 26, 2021
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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