Reported Jan 16, 2019 · Terminated
Ceftriaxone for Injection USP, 500 mg, packaged in a) one Single Use Vial (NDC 68180-622-01) and b) 10 Single Use Vials…
Lupin Pharmaceuticals Inc.
High riskUsing this product could cause serious injury, illness or death — stop using it now.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, 500 mg, packaged in a) one Single Use Vial (NDC 68180-622-01) and b) 10 Single Use Vials per box (NDC 68180-622-10); 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) C600173Exp 08/19C600218Exp 09/19b) C600126C600127C600137C600143Exp 08/19C600219Exp 09/19C700146Exp 05/20C700208C700209Exp 09/20
- Amount recalled
- a) 8,000 vials; b) 32,045 boxes
This recall covers 6 products
The agency filed one notice per product. You are reading one of them; the other 5 are below.
Where it was sold
- Nationwide
- PR
Why it was recalled
Stop using this product now
Presence of Particulate Matter: Product complaints received of grey flecks, identified as shredded rubber particulate matter from the stopper observed in reconstituted vials.
Using this product could cause serious injury, illness or death — stop using it now.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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