Lupin Pharmaceuticals Inc. recalls Ceftriaxone Sodium (Sterile) USP active pharmaceutical ingredient, DMF No. 15931; Manufactured by: Lupin Limited, Unit-1
Recalled June 8, 2016 · FDA recall D-0955-2016 · Lupin Pharmaceuticals
Hazard
CGMP Deviations: active pharmaceutical ingredient intermediates failed specifications. · FDA Class III
Units
741.171 kg
Sold at
Nationwide and Puerto Rico
Description
CGMP Deviations: active pharmaceutical ingredient intermediates failed specifications.
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- 400 098, (Maharashtra) India.
Manufacturer(s)
Lupin Pharmaceuticals Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →