FDAFDA · Food and drugs·Recall number D-0376-2019
Cefdinir for Oral Suspension USP, 250mg/5mL, packaged in a) 60mL (NDC 68180-723-20), b)100mL (NDC 68180-723-10), 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 #: F700343, F700344, F700345, F700346, F700347,F700376, F700377, F700415, F700146,F700417, F700418, Exp. Jan 2019; F700419, F700420, F700492, F700493,F700508,F700665, Exp. February 2019; F700784, Exp. April 2019; b) Lot #: F700324, F700325, F700326, Exp. January 2019; F700618, F700619, F700620, Exp. February 2019.
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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