DEXAMETHASONE 4 mg/1
DEXAMETHASONE · TABLET · Direct Rx
DEXAMETHASONE is a tablet containing dexamethasone at 4 mg/1, taken oral. Manufactured by Direct Rx.
Key Facts
- Brand Name
- DEXAMETHASONE
- Generic Name
- DEXAMETHASONE
- NDC Code (Product)
72189-254- Manufacturer
- Direct Rx
- Strength
- 4 mg/1
- Dosage Form
- TABLET
- Route
- ORAL
- Marketing Status
- Application #
- ANDA084612
- Drug Class
- Corticosteroid [EPC]
- Marketing Start
- 09/20/2021
Recall History
Main Street Family Pharmacy, LLC
The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials.
Main Street Family Pharmacy, LLC
The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials.
FVS Holdings, Inc. dba. Green Valley Drugs
Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.
West-Ward Pharmaceuticals Corp.
Failed Impurities/Degradation Specifications: high out of specification results for Dexamethasone adduct (related compound).
Sandoz Inc
Labeling: Incorrect or missing package insert.
Eugia US LLC
Failed Impurities/Degradation Specifications: impurity sulfonic acid adduct of dexamethasone phosphate results were above spec.
US Compounding Inc
Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
FVS Holdings, Inc. dba. Green Valley Drugs
Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.
Edge Pharma, LLC
Lack of Assurance of Sterility
Main Street Family Pharmacy, LLC
The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Frequently Asked Questions
What is DEXAMETHASONE used for?
DEXAMETHASONE contains DEXAMETHASONE. It is a tablet taken oral. Consult your doctor for specific uses.
Is DEXAMETHASONE a controlled substance?
DEXAMETHASONE is not classified as a controlled substance by the DEA.
What is the generic name for DEXAMETHASONE?
The generic name for DEXAMETHASONE is DEXAMETHASONE. There are 10 other brand versions of DEXAMETHASONE.
What is the NDC code for DEXAMETHASONE 4 mg/1?
The NDC (National Drug Code) for DEXAMETHASONE 4 mg/1 is 72189-254, listed by Direct Rx.
Other DEXAMETHASONE Dosages
Other Dexamethasone Brands
See all →- Dexamethasone6 mg/10054-8183
- Dexamethasone Sodium Phosphate10 mg/mL72485-118
- Dexamethasone Sodium Phosphate4 mg/mL76420-398
- Dexamethasone Sodium Phosphate10 mg/mL76420-399
- Mardex 25 Kit76420-810
- Dexamethasone4 mg/180425-0328
- Hemady20 mg/182111-955
- Dexamethasone1.5 mg/182804-132
- Dexamethasone Sodium Phosphate10 mg/mL0641-0367
- Dexamethasone2 mg/143063-266
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)