Drugplain

ENGERIX-B 20 ug/mL

Hepatitis B Vaccine (Recombinant) · INJECTION, SUSPENSION · A-S Medication Solutions

1 Recall on Record
Plain English

ENGERIX-B is a injection, suspension containing hepatitis b vaccine (recombinant) at 20 ug/mL, taken intramuscular. Manufactured by A-S Medication Solutions.

Key Facts

Brand Name
ENGERIX-B
Generic Name
Hepatitis B Vaccine (Recombinant)
NDC Code (Product)
50090-1223
Manufacturer
A-S Medication Solutions
Strength
20 ug/mL
Dosage Form
INJECTION, SUSPENSION
Route
INTRAMUSCULAR
Marketing Status
Application #
BLA103239
Marketing Start
03/28/2007

Recall History

1 Recall on Record
Class II05/25/2012

Franck's Lab Inc., d.b.a. Franck's Compounding Lab

Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.

TerminatedVoluntary: Firm initiated

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

USES: • For the temporary relief of symptoms including: • fever • fatigue • headache • muscle aches and pains • rash These statements are based upon homeopathic principles. They have not been reviewed by the Food and Drug Administration.

Dosage & Administration

DIRECTIONS: 1-10 drops under the tongue, 3 times a day or as directed by a health professional. Consult a physician for use in children under 12 years of age.

Warnings

WARNINGS: If pregnant or breastfeeding, ask a health professional before use. Keep out of reach of children. In case of overdose, contact a physician or Poison Control Center right away. Tamper Evident: Sealed for your protection. Do not use if seal is broken or missing.

Frequently Asked Questions

What is ENGERIX-B used for?

ENGERIX-B contains Hepatitis B Vaccine (Recombinant). It is a injection, suspension taken intramuscular. Consult your doctor for specific uses.

Is ENGERIX-B a controlled substance?

ENGERIX-B is not classified as a controlled substance by the DEA.

What is the generic name for ENGERIX-B?

The generic name for ENGERIX-B is Hepatitis B Vaccine (Recombinant). There are 10 other brand versions of Hepatitis B Vaccine (Recombinant).

What is the NDC code for ENGERIX-B 20 ug/mL?

The NDC (National Drug Code) for ENGERIX-B 20 ug/mL is 50090-1223, listed by A-S Medication Solutions.

Product NDC

50090-1223

Package NDC

50090-1223-1

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

Data from openFDA · Public domain (CC0 1.0)