The Recall Desk
Agency classClass IIIOur severity:LowFDA (Drugs)·D-0952-2016·Announced 2016-06-08

Lupin Recalls Ceftriaxone Injection Vials Due to CGMP Deviations

Lupin Pharmaceuticals is recalling Ceftriaxone for Injection USP, 500 mg, because the active ingredients used in manufacturing failed specifications.

The agency’s classification

FDA (Drugs): Class III

Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

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 1/5 (Low).

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The FDA classified this recall as Class III, which by definition is unlikely to cause adverse health consequences, aligning with the 'Low' severity criteria for documentation or minor manufacturing issues.

Plain-English summary

Lupin Pharmaceuticals, Inc. is recalling Ceftriaxone for Injection USP, 500 mg, Single Use Vials. The recall involves 7,908 vials distributed nationwide and in Puerto Rico. The affected products are packaged in 1-count and 10-count boxes with NDCs 68180-622-01 and 68180-622-10, respectively.

The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. Specifically, the finished products were manufactured using active pharmaceutical ingredients whose intermediates failed specifications. The affected lots are C500006 and C500001, both with an expiration date of 11/17.

Healthcare providers and patients should stop using the affected vials and contact their healthcare provider for guidance. The FDA has classified this recall as Class III, indicating that use of or exposure to the violative product is not likely to cause adverse health consequences.

The recalled product

Product
Ceftriaxone for Injection USP, 500 mg, Single Use Vial, packaged in a) 1-count Vials per box (NDC 68180-622-01), and b) 10-count Vials per box (NDC 68180-622-10), Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., 111 South Calvert Street, Baltimore, Maryland 21202…
Manufacturer
Lupin Pharmaceuticals Inc.
Category
Drug — Antibiotic
Hazard
Affected units
7,908

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 (3)

  • Lot #: a) C500006
  • Exp 11/17
  • b) C500001

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 5 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 5 products in this recall →

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