FDAFDA · Food and drugs·Recall number D-0375-2019
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
Published January 16, 2019 · Recall initiated: January 2, 2019
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
CGMP Deviations: Product complaints received indicating reconstituted suspension was observed to be thick.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- CEFDINIR
- Manufacturer
- Lupin Pharmaceuticals Inc.
- Distributor
- Nationwide within the United States
- UPC
- 0368180723042
- Lot
- a) Lot #: F700329, F700330, F700328, Exp. January 2019; F700544, F700545, F700668, F700669, F700670, Exp. March 2019; F700958, Exp. April 2019 b) Lot #: F700327, F700392, F700393, Exp. January 2019; F700546, F700547, F700664, Exp. March 2019; F700967, Exp. April 2019, F701106, F701107, F701108, F701109, Exp. May 2019.
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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