The Recall Desk
CriticalFDA (Drugs)·D-0358-2019·Announced 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.

What this means for you

Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.

Our severity reasoning: The agency classification is FDA Class I, which mandates a severity score of 5 according to the rubric.

Plain-English summary

Lupin Pharmaceuticals, Inc. is recalling Ceftriaxone for Injection USP, 2 g, packaged in 10 Single Use Vials. The recall affects 3,792 boxes of the product, which is distributed nationwide in the USA and Puerto Rico. The specific lots involved are C600109 (Exp 05/19), C600129, and C600135 (Exp 08/19).

The recall was initiated because of product complaints identifying grey flecks in reconstituted vials. These flecks were identified as shredded rubber particulate matter originating from the stopper.

Healthcare providers and patients should stop using the affected lots of Ceftriaxone for Injection USP. The product is prescription-only, and users should contact their healthcare provider for guidance on alternative treatments or further instructions.

The recalled product

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 68180-644-10.
Manufacturer
Lupin Pharmaceuticals Inc.
Category
Drug — Antibiotic Injection
Hazard
Affected units
3,792

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (5)

  • Lot #: C600109
  • Exp 05/19
  • C600129
  • C600135
  • Exp 08/19

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 4 recalled by Lupin Pharmaceuticals Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 4 products in this recall →

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Same hazard · particulate matter

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