Agency classClass IIIOur severity:Low FDA (Drugs)·D-0954-2016·Announced 2016-06-08

Lupin Recalls Ceftriaxone Injection Vials Due to CGMP Deviations

Lupin Pharmaceuticals is recalling 570 vials of Ceftriaxone for Injection USP, 2 g, because the active pharmaceutical 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 the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences. The issue is a manufacturing deviation (CGMP) without reported injuries or illnesses.

Plain-English summary

Lupin Pharmaceuticals, Inc. is recalling 570 vials of Ceftriaxone for Injection USP, 2 g, Single Use Vial (NDC 68180-644-01) packaged in 10-count boxes (NDC 68180-644-10). The affected product is identified by Lot # C500037 and has an expiration date of 01/18. The product was distributed nationwide and in Puerto Rico.

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 labeling error.

Healthcare providers and patients should stop using the affected vials and contact their pharmacist or Lupin Pharmaceuticals for further instructions. The FDA has classified this recall as Class III, which means the product is not likely to cause adverse health consequences.

The recalled product

Product: Ceftriaxone for Injection USP, 2 g, Single Use Vial (NDC 68180-644-01) packaged in 10-count Vials per box (NDC 68180-644-10), 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: cgmp-deviation
quality-control
Affected units: 570

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 (2)

Lot #: C500037
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 →

Same manufacturer · Lupin Pharmaceuticals Inc.

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