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.
What this means for you
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 09
- Manufacturer
- Lupin Pharmaceuticals Inc.
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
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.
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