Reported Jun 15, 2016 · Terminated
CEFTRIAXONE for Injection USP, 250mg/vial, Rx only, MFG: LUPIN LIMITED INDIA, Packaged by Aidarex Pharmaceuticals, NDC…
Aidarex Pharmaceuticals LLC
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: Aidarex Pharmaceuticals LLC · 595 N Smith Ave Ste B · Corona, CA · 92880-6920
Is this the product you have?
- CEFTRIAXONE for Injection USP, 250mg/vial, Rx only
- MFGLUPIN LIMITED INDIA, Packaged by Aidarex Pharmaceuticals, NDC 53217-0117-01
- Lot codes and dates
Lot#: 47312-1Exp 01/2018
- Amount recalled
- 10
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
CGMP Deviations: Out of specification (OOS) intermediate in the subsequent processes to manufacture the final API.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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