Ceftriaxone Sodium USP active pharmaceutical ingredient recalled over manufacturing violations
- Recall date
- March 11, 2016
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Lupin Pharmaceuticals Inc. recalls Ceftriaxone Sodium (Sterile) USP active pharmaceutical ingredient, DMF No. 15931; Manufactured by: Lupin Limited, Unit-…
- Recall number
- D-0955-2016
- FDA classification
- Class III
- Brand / firm
- Lupin Pharmaceuticals Inc.
- Sold / distributed
- Nationwide and Puerto Rico
Why it was recalled
CGMP Deviations: active pharmaceutical ingredient intermediates failed specifications.
Class III means the product violates regulations but is not likely to cause harm.
What was recalled
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.
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