cefdinir 125 mg/5mL
cefdinir · POWDER, FOR SUSPENSION · Preferred Pharmaceuticals Inc.
cefdinir is a powder, for suspension containing cefdinir at 125 mg/5mL, taken oral. Manufactured by Preferred Pharmaceuticals Inc..
Key Facts
- Brand Name
- cefdinir
- Generic Name
- cefdinir
- NDC Code (Product)
68788-8115- Manufacturer
- Preferred Pharmaceuticals Inc.
- Strength
- 125 mg/5mL
- Dosage Form
- POWDER, FOR SUSPENSION
- Route
- ORAL
- Marketing Status
- Application #
- ANDA210534
- Drug Class
- Cephalosporin Antibacterial [EPC]
- Marketing Start
- 12/07/2021
Recall History
Lupin Pharmaceuticals Inc.
CGMP Deviations: Product complaints received indicating reconstituted suspension was observed to be thick.
Lupin Pharmaceuticals Inc.
Presence of foreign substance: Product complaint of foreign material in reconstituted bottle.
Lupin Pharmaceuticals Inc.
Superpotent Drug
Lupin Pharmaceuticals Inc.
CGMP Deviations: Product complaints received indicating reconstituted suspension was observed to be thick.
Lupin Pharmaceuticals Inc.
Defective container: lack of seal integrity.
Lupin Pharmaceuticals Inc.
Superpotent Drug: Out-of-specification (OOS) result observed in an assay test of retention samples.
Lupin Pharmaceuticals Inc.
Presence of Foreign substance: identified as a dead ant.
Lupin Pharmaceuticals Inc.
Presence of Foreign substance: identified as a dead ant.
Teva Pharmaceuticals USA, Inc.
Defective Container: This recall is being carried out due to the potential for improperly sealed bottles.
Lupin Pharmaceuticals Inc.
Complaint received of metal piece identified in the product bottle prior to the reconstitution.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Frequently Asked Questions
What is cefdinir used for?
cefdinir contains cefdinir. It is a powder, for suspension taken oral. Consult your doctor for specific uses.
Is cefdinir a controlled substance?
cefdinir is not classified as a controlled substance by the DEA.
What is the generic name for cefdinir?
The generic name for cefdinir is cefdinir. There are 12 other brand versions of cefdinir.
What is the NDC code for cefdinir 125 mg/5mL?
The NDC (National Drug Code) for cefdinir 125 mg/5mL is 68788-8115, listed by Preferred Pharmaceuticals Inc..