FDAFDA · Food and drugs·Recall number D-0953-2016
Ceftriaxone for Injection USP, 1 g, Single Use Vial (NDC 68180-633-01) packaged in 10-count Vials per box (NDC 68180-633-10), Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., 111 South Calvert Street, Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Mandideep 462 046 INDIA, NDC 68180-633-01.
Published June 8, 2016 · Recall initiated: March 11, 2016
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: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Lupin Pharmaceuticals Inc.
- Distributor
- Nationwide and Puerto Rico
- Lot
- Lot #: C400180, Exp 07/17; C500003, C500028, C500029, Exp 122/17; C500038, Exp 01/18; C500044, Exp 02/18
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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