Drugplain

10 mg/.7mL

Midazolam Injection, 10 mg · INJECTION, SOLUTION · Rafa Laboratories, Ltd.

10 Recalls on RecordCurrently in Shortage
Plain English

is a injection, solution containing midazolam injection, 10 mg at 10 mg/.7mL, taken intramuscular. Manufactured by Rafa Laboratories, Ltd..

Key Facts

Brand Name
Generic Name
Midazolam Injection, 10 mg
NDC Code (Product)
71053-595
Manufacturer
Rafa Laboratories, Ltd.
Strength
10 mg/.7mL
Dosage Form
INJECTION, SOLUTION
Route
INTRAMUSCULAR
Marketing Status
DEA Schedule
Schedule IV (Controlled)
Application #
NDA216359
Drug Class
Benzodiazepine [EPC]
Marketing Start
08/08/2022

Recall History

10 Recalls on Record
Class II09/03/2015

Kalman Health & Wellness, Inc. dba Essential Wellness Pharma

Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to observations associated with poor sterile production practices resulting in a lack of sterility assurance for their finished drugs.

TerminatedVoluntary: Firm initiated
Class II07/30/2020

Albek De Mexico S.A. De C.V.

CGMP Deviations: Next Advanced Antibacterial Hand Sanitizer was found to be below the label claim for ethanol content and contained methanol. Other products were recalled because they were manufactured in the same facility as the product found to contain methanol.

OngoingVoluntary: Firm initiated
Class II10/15/2025

ProRx LLC

Lack of Assurance of Sterility

OngoingVoluntary: Firm initiated
Class II05/22/2020

Teva Pharmaceuticals USA

Some bottles may contain mixed strengths of the product.

TerminatedVoluntary: Firm initiated
Class II10/26/2021

Perrigo Company PLC

CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.

TerminatedVoluntary: Firm initiated
Class II05/05/2016

Pharmedium Services, LLC

Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.

TerminatedVoluntary: Firm initiated
Class III07/08/2014

Pfizer Inc.

Labeling: Incorrect or missing lot and or Exp Date: The bottles were labeled with an incorrect expiry date 11/2016. The correct expiry date is 09/2016.

TerminatedVoluntary: Firm initiated
Class II06/20/2024

Little Moon Essentials LLC

CGMP deviations

OngoingVoluntary: Firm initiated
Class II09/10/2018

Pharm D Solutions, LLC

Lack of Assurance of Sterility

TerminatedVoluntary: Firm initiated
Class II09/13/2013

AmeriSource Bergen

Temperature abuse: Certain vials of Ifosfamide IV products were not refrigerated at certain Amerisource Bergen Drug Corp distribution centers.

TerminatedVoluntary: Firm initiated

Frequently Asked Questions

What is used for?

contains Midazolam Injection, 10 mg. It is a injection, solution taken intramuscular. Consult your doctor for specific uses.

Is a controlled substance?

Yes, is classified as CIV under the DEA Controlled Substances Act.

What is the generic name for ?

The generic name for is Midazolam Injection, 10 mg. There are no other listed brand versions of Midazolam Injection, 10 mg.

What is the NDC code for 10 mg/.7mL?

The NDC (National Drug Code) for 10 mg/.7mL is 71053-595, listed by Rafa Laboratories, Ltd..

Product NDC

71053-595

Package NDC

71053-595-01

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)