FDAFDA · Food and drugs·Recall number D-0952-2016
Ceftriaxone for Injection USP, 500 mg, Single Use Vial, packaged in a) 1-count Vials per box (NDC 68180-622-01), and b) 10-count Vials per box (NDC 68180-622-10), Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., 111 South Calvert Street, Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Mandideep 462 046 INDIA.
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 #: a) C500006, Exp 11/17; b) C500001, Exp 11/17
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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