The Recall Desk
Agency classClass IOur severity:SevereFDA (Drugs)·D-0357-2019·Announced 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.

The agency’s classification

FDA (Drugs): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. 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 severity score of at least 4 per the rubric, as the presence of particulate matter in an injectable drug poses a significant risk of serious injury.

Plain-English summary

Lupin Pharmaceuticals, Inc. is recalling Ceftriaxone for Injection USP, 1 g, packaged in single-use vials and boxes of ten vials. The recall was initiated after product complaints identified grey flecks in reconstituted vials, which were confirmed to be shredded rubber particulate matter originating from the stopper.

The affected product is distributed nationwide in the USA and Puerto Rico. Specific lot numbers and expiration dates are listed in the official recall documentation. The product is prescription-only and manufactured by Lupin Limited in India for Lupin Pharmaceuticals, Inc. in Baltimore, Maryland.

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 and to report any adverse reactions associated with the use of the recalled product.

The recalled 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…
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 (20)

  • Lot #: a) C600110
  • Exp 05/19
  • C600130
  • Exp 08/19
  • C700113
  • Exp 03/20
  • C700143
  • Exp 05/20
  • b) C600106
  • C600108
  • C600128
  • C600138
  • C600174
  • C600179
  • C600180
  • C600181
  • Exp 09/19
  • C700108
  • C700109
  • C700110

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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