Agency classClass IIIOur severity:Low FDA (Drugs)·D-0955-2016·Announced 2016-06-08

Lupin Recalls Ceftriaxone Sodium API Due to CGMP Deviations

Lupin Pharmaceuticals Inc. is recalling Ceftriaxone Sodium (Sterile) USP active pharmaceutical ingredient because intermediates 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.

Plain-English summary

Lupin Pharmaceuticals Inc. is recalling Ceftriaxone Sodium (Sterile) USP active pharmaceutical ingredient (DMF No. 15931). The product was manufactured by Lupin Limited in India and distributed nationwide and in Puerto Rico. The total quantity involved is 741.171 kg.

The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. Specifically, active pharmaceutical ingredient intermediates failed to meet specifications. The affected lots include B4000935, B4005178, B4008730, B4008729, B4008727, B4008724, B5001647, B5001648, and B5001649, with expiration dates ranging from January 2017 to February 2018.

The U.S. Food and Drug Administration has classified this recall as Class III. This classification indicates that the product is not likely to cause adverse health consequences. Consumers and healthcare providers should check their inventory for these specific lot numbers and stop using the product if found.

The recalled product

Product: Ceftriaxone Sodium (Sterile) USP active pharmaceutical ingredient, DMF No. 15931; Manufactured by: Lupin Limited, Unit-1, 198-202, New Industrial Area No. 2, Dist. Raisen, Mandideep-462 046, (Madhya Pradesh) India; Regd. Office: 159, CST Road Kalina, Santacruz (E), Mumbai- 400…
Manufacturer: Lupin Pharmaceuticals Inc.
Category: Drug — Active Pharmaceutical Ingredient
Hazard: cgmp-deviation
specification-failure

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 (13)

Lot #: B4000935
Exp 01/17
B4005178
Exp 06/17
B4008730
B4008729
B4008727
B4008724
Exp 10/17
B5001647
B5001648
B5001649
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 →

Same manufacturer · Lupin Pharmaceuticals Inc.

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