The Recall Desk
Agency classClass IIIOur severity:LowFDA (Drugs)·D-0953-2016·Announced 2016-06-08

Lupin Recalls Ceftriaxone Injection Vials Due to CGMP Deviations

Lupin Pharmaceuticals is recalling Ceftriaxone for Injection vials because they were manufactured using active pharmaceutical ingredients that 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 source text identifies this as an FDA Class III recall, which the rubric defines as typically scoring 1 or 2 because it is unlikely to cause adverse health consequences.

Plain-English summary

Lupin Pharmaceuticals, Inc. is recalling Ceftriaxone for Injection USP, 1 g, Single Use Vials (NDC 68180-633-01) packaged in 10-count boxes (NDC 68180-633-10). The recall involves 30,586 vials distributed nationwide and in Puerto Rico. The affected lots include C400180 (Exp 07/17), C500003, C500028, and C500029 (Exp 12/17), C500038 (Exp 01/18), and C500044 (Exp 02/18).

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. This is an FDA Class III recall, which indicates that the use of or exposure to the product is not likely to cause adverse health consequences.

Healthcare providers and patients should stop using the affected vials and contact Lupin Pharmaceuticals for further instructions or a refund. Consumers should check their medication packaging for the NDC numbers and lot numbers listed above to determine if they are affected.

The recalled product

Product
Ceftriaxone for Injection USP, 1 g, Single Use Vial (NDC 68180-633-01) packaged in 10-count Vials per box (NDC 68180-633-10), Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., 111 South Calvert Street, Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Mandideep…
Manufacturer
Lupin Pharmaceuticals Inc.
Category
Drug — Antibiotic Injection
Hazard
Affected units
30,586

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 #: C400180
  • Exp 07/17
  • C500003
  • C500028
  • C500029
  • Exp 122/17
  • C500038
  • Exp 01/18
  • C500044
  • Exp 02/18

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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