Reported Jan 16, 2019 · Terminated
Ceftriaxone for Injection USP, 1 g, packaged in a) one Single Use Vial (NDC 68180-633-01) 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, 1 g, packaged in a) one Single Use Vial (NDC 68180-633-01) and b) 10 Single Use Vials per box (NDC 68180-633-10); Rx only
- Manufactured forLupin Pharmaceuticals, Inc., 111 South Calvert Street, Baltimore, Maryland 21202
- Manufactured byLupin Limited, Mandideep 462 046 INDIA
- Lot codes and dates
9 of 9 products
Products covered by this recall # Product as published 1 C600110, Exp 05/19 2 C600130, Exp 08/19 3 C700113, Exp 03/20 4 C700143, Exp 05/20 5 C600106, C600108, Exp 05/19 6 C600128, C600138, Exp 08/19 7 C600174, C600179, C600180, C600181, Exp 09/19 8 C700108, C700109, C700110, C700111, C700112, Exp 03/20 9 C700129, C700130, C700131, C700132, C700138, C700142, C700145, Exp 05/20 - Amount recalled
- a) 35,000 vials; b) 112,641 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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