Class II · Moderate risk Terminated
Cefdinir for Oral Suspension USP, 250 mg/5 mL, packaged in a 60 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals…
Reason Defective container: lack of seal integrity.
Is Cefdinir recalled?
11 FDA recalls mention Cefdinir. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Cefdinir.
Class II · Moderate risk Terminated
Cefdinir for Oral Suspension USP 125 mg/5 mL (60 mL when reconstituted), 60 mL bottle, Rx only, Manufactured for: Lupin…
Reason Presence of foreign substance: Product complaint of foreign material in reconstituted bottle.
Class II · Moderate risk Terminated
Cefdinir for Oral Suspension USP 250 mg/5 mL (60 mL when reconstituted), 60 mL bottle, Rx only, Manufactured for: Lupin…
Reason Presence of foreign substance: Product complaint of foreign material in reconstituted bottle.
Class II · Moderate risk Terminated
Cefdinir for Oral Suspension USP, 250 mg/5mL, packaged in 60 mL bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc…
Reason Superpotent Drug: Out-of-specification (OOS) result observed in an assay test of retention samples.
Class III · Low risk Terminated
Cefdinir for Oral Suspension USP, 125 mg/5mL, packaged in a) 60 mL bottle (NDC 68180-722-20), b) 100 mL bottle (NDC…
Reason Presence of Foreign substance: identified as a dead ant.
Class III · Low risk Terminated
Cefdinir for Oral Suspension USP, 250 mg/5mL,100 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore…
Reason Presence of Foreign substance: identified as a dead ant.
Class II · Moderate risk Terminated
Cefdinir for Oral Suspension USP, 250mg/5mL, Powder for oral suspension, 60 mL bottle, Rx only, Manufactured for: Lupin…
Reason Complaint received of metal piece identified in the product bottle prior to the reconstitution.
Class II · Moderate risk Terminated
Cefdinir for Oral Suspension USP, 250mg/5mL, packaged in a) 60mL (NDC 68180-723-20), b)100mL (NDC 68180-723-10), Rx Only…
Reason CGMP Deviations: Product complaints received indicating reconstituted suspension was observed to be thick.
Class II · Moderate risk Terminated
Cefdinir for Oral Suspension USP, 125mg/5mL, packaged in a) 60mL (NDC 68180-722-20), b)100mL (NDC 68180-722-10), Rx Only…
Reason CGMP Deviations: Product complaints received indicating reconstituted suspension was observed to be thick.
Class II · Moderate risk Terminated
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 (…
Reason Superpotent Drug
Class II · Moderate risk Terminated
Cefdinir for Oral Suspension, 125 mg/5 mL, packaged in a) 60 mL bottle (NDC 0093-4136-64); b) 100 mL bottle (NDC 0093-4136-73)…
Reason Defective Container: This recall is being carried out due to the potential for improperly sealed bottles.
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