The Recall Desk
SevereFDA (Drugs)·D-0355-2019·Announced 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.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classification is FDA Class I, which mandates a minimum severity score of 4 according to the rubric.

Plain-English summary

Lupin Pharmaceuticals, Inc. is recalling Ceftriaxone for Injection USP, 250 mg, packaged in single-use vials and boxes of ten vials. The recall affects specific lots with expiration dates ranging from August 2019 to September 2020. The product was distributed nationwide in the United States and Puerto Rico.

The recall was initiated due to product complaints identifying grey flecks in reconstituted vials. These flecks were identified as shredded rubber particulate matter originating from the vial stoppers. The affected lots include C600142, C600136, C600182, C700147, and C700207.

Healthcare providers and patients should stop using the affected lots of Ceftriaxone for Injection USP. Consumers should contact their healthcare provider for guidance on alternative treatments or further instructions regarding the recalled product.

The recalled product

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: Lupin
Manufacturer
Lupin Pharmaceuticals Inc.
Category
Drug — Antibiotic Injection
Hazard

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 (10)

  • Lot #: a) C600142
  • Exp 08/19
  • b) C600136
  • C600182
  • Exp 09/19
  • C700147
  • Exp 05/20
  • C700207
  • Exp 09/20 Additional lots added 12/19/2018 - C600142
  • C700147 and C700207

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 →

Related recalls

Same manufacturer · Lupin Pharmaceuticals Inc.

See all →

Same hazard · particulate matter

See all →