PlainRecalls
FDA Drug Moderate Class II Terminated

Haloperidol Decanoate Injection, USP 50 mg/mL, 1 mL Single Dose Vials, Rx Only, Sterile, 10 Vials, Teva Pharmaceuticals, USA, Inc., North Wales, PA NDC 00703-7121-03

Reported: May 26, 2021 Initiated: April 26, 2021 #D-0375-2021

Product Description

Haloperidol Decanoate Injection, USP 50 mg/mL, 1 mL Single Dose Vials, Rx Only, Sterile, 10 Vials, Teva Pharmaceuticals, USA, Inc., North Wales, PA NDC 00703-7121-03

Reason for Recall

Lack of Assurance of Sterility

Details

Recalling Firm
Teva Pharmaceuticals USA
Units Affected
3150 vials
Distribution
Product was distributed nationwide.
Location
Parsippany, NJ

Frequently Asked Questions

What product was recalled?
Haloperidol Decanoate Injection, USP 50 mg/mL, 1 mL Single Dose Vials, Rx Only, Sterile, 10 Vials, Teva Pharmaceuticals, USA, Inc., North Wales, PA NDC 00703-7121-03. Recalled by Teva Pharmaceuticals USA. Units affected: 3150 vials.
Why was this product recalled?
Lack of Assurance of Sterility
Which agency issued this recall?
This recall was issued by the FDA Drug on May 26, 2021. Severity: Moderate. Recall number: D-0375-2021.