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.
Cefdinir for Oral Suspension USP, 125mg/5mL, packaged in a) 60mL (NDC 68180-722-20)…
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
CGMP Deviations: Product complaints received indicating reconstituted suspension was observed to be thick.
What was recalled
Cefdinir for Oral Suspension USP, 125mg/5mL, packaged in a) 60mL (NDC 68180-722-20), b)100mL (NDC 68180-722-10), Rx Only, Manufactured for: Lupin Pharmaceuticals Inc. Baltimore, MD 21202; Manufactured by: Lupin Limited Mandideep 462 046 INDIA
- Recalling firm
- Lupin Pharmaceuticals Inc.
- NDC code
- 68180-722-20
- Origin
- MD, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0375-2019
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Cefdinir recalls
See all
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.
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