Drugplain

2 mg/.7mL

Atropine Injection, 2 mg · INJECTION · Rafa Laboratories, Ltd.

10 Recalls on RecordCurrently in Shortage
Plain English

is a injection containing atropine injection, 2 mg at 2 mg/.7mL, taken intramuscular. Manufactured by Rafa Laboratories, Ltd..

Key Facts

Brand Name
Generic Name
Atropine Injection, 2 mg
NDC Code (Product)
71053-592
Manufacturer
Rafa Laboratories, Ltd.
Strength
2 mg/.7mL
Dosage Form
INJECTION
Route
INTRAMUSCULAR
Marketing Status
Application #
NDA212319
Drug Class
Anticholinergic [EPC]; Cholinergic Muscarinic Antagonist [EPC]
Marketing Start
07/09/2018

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 Atropine Injection, 2 mg. It is a injection taken intramuscular. Consult your doctor for specific uses.

Is a controlled substance?

is not classified as a controlled substance by the DEA.

What is the generic name for ?

The generic name for is Atropine Injection, 2 mg. There are no other listed brand versions of Atropine Injection, 2 mg.

What is the NDC code for 2 mg/.7mL?

The NDC (National Drug Code) for 2 mg/.7mL is 71053-592, listed by Rafa Laboratories, Ltd..

Product NDC

71053-592

Package NDC

71053-592-01

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

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