The Recall Desk

FDA (Drugs) recall action 81796

Lupin Pharmaceuticals Inc. recalled 4 products on 2019-01-16

The FDA (Drugs) publishes a recall like this one as 4 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 4 pages.

Products
4
Announced
2019-01-16
Critical
1
Units
3,792

Why these products were recalled

Presence of Particulate Matter: Product complaints received of grey flecks, identified as shredded rubber particulate matter from the stopper observed in reconstituted vials.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–4 of 4

  • SevereFDA (Drugs)··2019-01-16

    Lupin Recalls Ceftriaxone Injection Vials Due to Rubber Particulate Matter

    Lupin Pharmaceuticals is recalling Ceftriaxone for Injection USP vials because grey rubber flecks were found in the reconstituted product.

    Product
    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 for: Lupin Pharmaceuticals, Inc., 111 South Calvert Street, Baltimore, Maryland 21202; Manufactured by: Lupin…
    Category
    Distribution
    1 state
  • SevereFDA (Drugs)··2019-01-16

    Lupin Recalls Ceftriaxone Injection Vials Due to Rubber Particulate Matter

    Lupin Pharmaceuticals is recalling Ceftriaxone for Injection USP, 250 mg, due to the presence of grey rubber particulate matter from stoppers in reconstituted vials.

    Product
    Ceftriaxone for Injection USP, 250 mg, packaged in a) one Single Use Vial (NDC 68180-611-01) and b) 10 Single Use Vials per box (NDC 68180-611-10); Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., 111 South Calvert Street, Baltimore, Maryland 21202; Manufactured by…
    Category
    Distribution
    1 state
  • SevereFDA (Drugs)··2019-01-16

    Lupin Recalls Ceftriaxone Injection Vials Due to Particulate Matter

    Lupin Pharmaceuticals is recalling Ceftriaxone for Injection USP, 500 mg, due to the presence of grey rubber particulate matter from stoppers.

    Product
    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 for: Lupin Pharmaceuticals, Inc., 111 South Calvert Street, Baltimore, Maryland 21202; Manufactured by…
    Category
    Distribution
    1 state
  • CriticalFDA (Drugs)··2019-01-16

    Lupin Recalls Ceftriaxone Injection Vials Due to Rubber Particulate Matter

    Lupin Pharmaceuticals is recalling Ceftriaxone for Injection USP due to the presence of grey rubber particulate matter in the vials.

    Product
    Ceftriaxone for Injection USP, 2 g, packaged in 10 Single Use Vials (NDC 68180-644-01) per box, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., 111 South Calvert Street, Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Mandideep 462 046 INDIA, NDC…
    Category
    Distribution
    1 state