Reported Jun 8, 2016 · Terminated
Ceftriaxone for Injection USP, 250 mg, Single Use Vial, packaged in a) 1-count Vials per box (NDC 68180-611-01), and b)…
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, 250 mg, Single Use Vial, packaged in a) 1-count Vials per box (NDC 68180-611-01), and b) 10-count Vials per box (NDC 68180-611-10), Rx only
- Manufactured forLupin Pharmaceuticals, Inc., 111 South Calvert Street, Baltimore, Maryland 21202
- Manufactured byLupin Limited, Mandideep 462 046 INDIA
- Lot codes and dates
Lot #: a) C500031Exp 12/17b) C500026Exp 12/17C500036C500043Exp 01/18
- Amount recalled
- 15408 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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