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
1C600110, Exp 05/19
2C600130, Exp 08/19
3C700113, Exp 03/20
4C700143, Exp 05/20
5C600106, C600108, Exp 05/19
6C600128, C600138, Exp 08/19
7C600174, C600179, C600180, C600181, Exp 09/19
8C700108, C700109, C700110, C700111, C700112, Exp 03/20
9C700129, 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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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Aug 18, 2020 · Data as of Sep 19, 7:47 PM UTC

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