CEFDINIR

Generic: CEFDINIR

Sandoz IncManufacturer

ORALRoute

CEFDINIRActive Substance

2007-04-06Original Approval

CEFDINIR is FDA application ANDA065330, sponsored by CHARTWELL RX. Any recalls listed below come from FDA drug enforcement reports, and reaction counts are the number of FAERS adverse event reports that mention the drug and that reaction; a report does not prove the drug caused it.

Recalls

Class II2019-01-02

Cefdinir for Oral Suspension USP, 125mg/5mL, packaged in a) 60mL (NDC 68180-722-20), b)100mL (NDC 68180-722-10), Rx Only

CGMP Deviations: Product complaints received indicating reconstituted suspension was observed to be

Class II2024-04-24

Cefdinir for Oral Suspension USP 250 mg/5 mL (60 mL when reconstituted), 60 mL bottle, Rx only, Manufactured for: Lupin

Presence of foreign substance: Product complaint of foreign material in reconstituted bottle.

Class II2018-03-27

Lupin Cefdinir powder for Oral Suspension USP, 250 mg/5 mL in (a) 60 mL packs ( NDC 68180-723-20) and (b) 100 mL packs

Superpotent Drug

Class II2019-01-02

Cefdinir for Oral Suspension USP, 250mg/5mL, packaged in a) 60mL (NDC 68180-723-20), b)100mL (NDC 68180-723-10), Rx Only

CGMP Deviations: Product complaints received indicating reconstituted suspension was observed to be

Class II2024-05-08

Cefdinir for Oral Suspension USP, 250 mg/5 mL, packaged in a 60 mL bottle, Rx only, Manufactured for: Lupin Pharmaceutic

Defective container: lack of seal integrity.

Class II2020-07-02

Cefdinir for Oral Suspension USP, 250 mg/5mL, packaged in 60 mL bottles, Rx only, Manufactured for: Lupin Pharmaceutical

Superpotent Drug: Out-of-specification (OOS) result observed in an assay test of retention samples.

Class III2019-11-01

Cefdinir for Oral Suspension USP, 250 mg/5mL,100 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Balt

Presence of Foreign substance: identified as a dead ant.

Class III2019-11-01

Cefdinir for Oral Suspension USP, 125 mg/5mL, packaged in a) 60 mL bottle (NDC 68180-722-20), b) 100 mL bottle (NDC 6818

Presence of Foreign substance: identified as a dead ant.

Class II2013-02-26

Cefdinir for Oral Suspension, 125 mg/5 mL, packaged in a) 60 mL bottle (NDC 0093-4136-64); b) 100 mL bottle (NDC 0093-41

Defective Container: This recall is being carried out due to the potential for improperly sealed bot

Class II2019-05-23

Cefdinir for Oral Suspension USP, 250mg/5mL, Powder for oral suspension, 60 mL bottle, Rx only, Manufactured for: Lupin

Complaint received of metal piece identified in the product bottle prior to the reconstitution.

CEFDINIR

Recalls

Top Reported Reactions