The Recall Desk
Agency classClass IIIOur severity:LowFDA (Drugs)·D-0951-2016·Announced 2016-06-08

Lupin Recalls Ceftriaxone Injection Vials Due to CGMP Deviations

Lupin Pharmaceuticals is recalling specific lots of Ceftriaxone for Injection USP 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 FDA classified this as a Class III recall, which by definition is unlikely to cause adverse health consequences. The hazard is a manufacturing deviation (CGMP) without reported illness or injury.

Plain-English summary

Lupin Pharmaceuticals, Inc. is recalling Ceftriaxone for Injection USP, 250 mg, Single Use Vials. The affected products are packaged in 1-count and 10-count boxes and are distributed nationwide and in Puerto Rico. The recall involves 15,408 vials from specific lots with expiration dates in December 2017 and January 2018.

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 indicates a quality control issue in the manufacturing process rather than a confirmed contamination or defect in the final product.

Healthcare providers and patients should stop using the affected lots immediately. The FDA has classified this as a Class III recall, which means the product is not likely to cause adverse health consequences. Consumers should check their medication vials for the specific lot numbers and expiration dates listed in the recall notice and contact their pharmacist or healthcare provider for guidance on replacement or disposal.

The recalled product

Product
Ceftriaxone for Injection USP, 250 mg, Single Use Vial, packaged in a) 1-count Vials per box (NDC 68180-611-01), and b) 10-count Vials per box (NDC 68180-611-10), Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., 111 South Calvert Street, Baltimore, Maryland 21202…
Manufacturer
Lupin Pharmaceuticals Inc.
Category
Drug — Antibiotic Injection
Hazard
Affected units
15,408

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 (6)

  • Lot #: a) C500031
  • Exp 12/17
  • b) C500026
  • C500036
  • C500043
  • Exp 01/18

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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