Drugplain

MEROPENEM 1 g/30mL

MEROPENEM · INJECTION · Savior Lifetec Corporation

9 Recalls on Record
Plain English

MEROPENEM is a injection containing meropenem at 1 g/30mL, taken intravenous. Manufactured by Savior Lifetec Corporation.

Key Facts

Brand Name
MEROPENEM
Generic Name
MEROPENEM
NDC Code (Product)
44647-033
Manufacturer
Savior Lifetec Corporation
Strength
1 g/30mL
Dosage Form
INJECTION
Route
INTRAVENOUS
Marketing Status
Application #
ANDA206086
Marketing Start
04/19/2016

Recall History

9 Recalls on Record
Class II09/20/2018

Pfizer Inc.

Lack of assurance of sterility: loss of container integrity.

TerminatedVoluntary: Firm initiated
Class II12/27/2022

Sentara Infusion Services

Lack of sterility assurance

TerminatedVoluntary: Firm initiated
Class II12/26/2014

Walgreens Infusion Services

Lack of sterility assurance.

TerminatedVoluntary: Firm initiated
Class II06/21/2013

AstraZeneca Pharmaceuticals LP

Presence of Precipitate; potential for incomplete constitution upon addition of diluent.

TerminatedVoluntary: Firm initiated
Class II04/18/2016

Baptist Health Medical Towers Pharmacy and Infusion Services

Lack of Sterility Assurance

TerminatedVoluntary: Firm initiated
Class II05/15/2014

Franck's Lab Inc dba Trinity Care Solutions

Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection.

OngoingVoluntary: Firm initiated
Class II11/10/2015

Walgreens Infusion Services

Lack of Assurance of Sterility

TerminatedVoluntary: Firm initiated
Class II10/24/2014

Hospira Inc.

Defective Container: Glass vials may crack due to low (thin) out of specification vial wall thickness which may lead to contamination and lack of assurance of sterility.

TerminatedVoluntary: Firm initiated
Class II09/18/2015

Sentara Enterprises

Lack of Assurance of Sterility: Product sterility cannot be guaranteed.

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

drug ineffective4,343 reports
off label use3,229 reports
pyrexia2,134 reports
pneumonia1,452 reports
sepsis1,387 reports
septic shock1,386 reports
multiple organ dysfunction syndrome1,259 reports
acute kidney injury1,241 reports
condition aggravated1,192 reports
thrombocytopenia1,106 reports

Frequently Asked Questions

What is MEROPENEM used for?

MEROPENEM contains MEROPENEM. It is a injection taken intravenous. Consult your doctor for specific uses.

Is MEROPENEM a controlled substance?

MEROPENEM is not classified as a controlled substance by the DEA.

What is the generic name for MEROPENEM?

The generic name for MEROPENEM is MEROPENEM. There are 10 other brand versions of MEROPENEM.

What is the NDC code for MEROPENEM 1 g/30mL?

The NDC (National Drug Code) for MEROPENEM 1 g/30mL is 44647-033, listed by Savior Lifetec Corporation.