Reported Jun 8, 2016 · Terminated
Ceftriaxone for Injection USP, 1 g, Single Use Vial (NDC 68180-633-01) packaged in 10-count Vials per box (NDC…
Lupin Pharmaceuticals Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Lupin Pharmaceuticals Inc. · 111 S Calvert St Fl 21ST · Baltimore, MD · 21202-6174
Is this the product you have?
- 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 forLupin Pharmaceuticals, Inc., 111 South Calvert Street, Baltimore, Maryland 21202
- Manufactured by
Lupin LimitedMandideep 462 046 INDIANDC 68180-633-01
- Lot codes and dates
Lot #: C400180Exp 07/17C500003C500028C500029Exp 122/17C500038Exp 01/18C500044Exp 02/18
- Amount recalled
- 30586 vials
This recall covers 5 products
The agency filed one notice per product. You are reading one of them; the other 4 are below.
Where it was sold
- Nationwide
- PR
Why it was recalled
CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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