Reported Jun 8, 2016 · Terminated
Ceftriaxone Sodium (Sterile) USP active pharmaceutical ingredient, DMF No. 15931; Manufactured by: Lupin Limited,…
Lupin Pharmaceuticals Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Lupin Pharmaceuticals Inc. · 111 S Calvert St Fl 21ST · Baltimore, MD · 21202-6174
Is this the product you have?
- Ceftriaxone Sodium (Sterile) USP active pharmaceutical ingredient, DMF No. 15931
- Manufactured byLupin Limited, Unit-1, 198-202, New Industrial Area No. 2, Dist. Raisen, Mandideep-462 046, (Madhya Pradesh) India; Regd
- Office159, CST Road Kalina, Santacruz (E), Mumbai- 400 098, (Maharashtra) India
- Lot codes and dates
Lot #: B4000935Exp 01/17B4005178Exp 06/17B4008730B4008729B4008727B4008724Exp 10/17B5001647B5001648B5001649Exp 02/18
- Amount recalled
- 741.171 kg
This recall covers 5 products
The agency filed one notice per product. You are reading one of them; the other 4 are below.
Where it was sold
- Nationwide
- PR
Why it was recalled
CGMP Deviations: active pharmaceutical ingredient intermediates failed specifications.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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