Class II · Moderate risk
Ceftriaxone for Injection
Lack of Assurance of Sterility
Ceftriaxone for Injection USP
Class I — High risk. Reasonable probability of serious harm or death.
Why it was recalled
Presence of Particulate Matter: Product complaints received of grey flecks, identified as shredded rubber particulate matter from the stopper observed in reconstituted vials.
Cause type: Particulate / foreign matter
Visible foreign particles - glass, metal, fibers or other material - found in the product. Particles can enter from equipment wear, containers or the process, and are dangerous in injectables. All particulate / foreign matter recalls.
What was recalled
Ceftriaxone for Injection USP, 1 g, packaged in a) one Single Use Vial (NDC 68180-633-01) and b) 10 Single Use Vials per box (NDC 68180-633-10); Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., 111 South Calvert Street, Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Mandideep 462 046 INDIA.
Affected NDCs
68180-0633-01
68180-0633-10
Compare with the code on your package — it is the most precise check available.
Drug: Ceftriaxone
- Recalling firm
- Lupin Pharmaceuticals Inc.
- NDC code
- 68180-633-01
- Origin
- MD, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0357-2019 · FDA notice
Treat this as urgent. Class I means FDA judged there is a reasonable probability of serious harm. Find the lot number on your package; if it matches the recalled lots, do not take another dose before you have spoken to your pharmacist or prescriber - today, not next week. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Ceftriaxone recalls
See all
Class II · Moderate risk
Ceftriaxone for Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Ceftriaxone for Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Ceftriaxone for Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Ceftriaxone for Injection
Lack of Assurance of Sterility
Other recalls by Lupin Pharmaceuticals Inc.
All 2018 recalls
Class II · Moderate risk
Clobetasol Propionate Cream USP
Failed content uniformity specifications.
Class II · Moderate risk
Glucagon Emergency Kit for Low Blood Sugar
CGMP deviation: OOS result observed for the Gliding Force functionality test during 12-month long term stability testing.
Class II · Moderate risk
prednisoLONE Acetate Ophthalmic Suspension
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Class II · Moderate risk
Liraglutide Injection
Presence of particulate matter: a white thread-like structure in the cartridge
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