Home / Recalls / AuroMedics Pharma LLC / D-0340-2018

D-0340-2018 Class I Terminated

Recalled by AuroMedics Pharma LLC — East Windsor, NJ

Recall Details

Product Type
Drugs
Report Date
February 14, 2018
Initiation Date
December 4, 2017
Termination Date
March 17, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
66,100 vials

Product Description

Pantoprazole Sodium for Injection, 40 mg per vial, single dose vial, Rx only, Manufactured in India for: AuroMedics Pharma LLC, 6 Wheeling ROad, Dayton, NJ 08810. NDC 55150-202-00

Reason for Recall

Presence of Particulate Matter: One vial from a lot of Pantoprazole Sodium for Injection (40 mg) contained a piece of glass

Distribution Pattern

Product was distributed nationwide in the USA

Code Information

Lot # CPO170035

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  • D-0248-2021 Class II — Acetaminophen Injection 1,000 mg per 100 mL (10 mg/mL), 100 mL Single Dose Vial, (December 30, 2020)
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  • D-0636-2020 Class I — Mirtazapine Tablets, USP, 15 mg, 500-count tablets, Rx only, Distributed by: Au (November 20, 2019)