Class II · Moderate risk
Endophth Kit
Lack of Assurance of Sterility
Ceftazidime for Injection USP and Dextrose for Injection USP
Class I — High risk. Reasonable probability of serious harm or death.
Why it was recalled
Failed Stability Specifications: Out-of-Specification (OOS) results for High Molecular Weight Polymers.
Cause type: Stability / shelf life
The product degraded or failed stability testing before its labeled expiry. Heat, moisture or time can break the drug down into degradants or reduce potency. All stability / shelf life recalls.
What was recalled
Ceftazidime for Injection USP and Dextrose for Injection USP, 2 g, 50 mL Duplex Container, RX only, B Braun Medical Inc., Bethlehem, PA 18018-3524, NDC 0264-3145-11
Affected NDC
0264-3145-11
Compare with the code on your package — it is the most precise check available.
Drug: Ceftazidime
- Recalling firm
- B. Braun Medical Inc
- NDC code
- 0264-3145-11
- Origin
- CA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1257-2020 · 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 Ceftazidime recalls
See all
Class II · Moderate risk
Ceftazidime Intravitreal
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Class II · Moderate risk
CEFTAZIDIME INTRAVITREAL 2.25MG/0.1ML Solution
Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile.
Class II · Moderate risk
Ceftazidime
Lack of Assurance of Sterility
Class II · Moderate risk
Ceftazidime Sterile Ophthalmic Solution for Injection Preservative Free 11.25mg / 0.5ml
Lack of Assurance of Sterility; the media used to conduct post-compounding sterility testing for the Methotrexate product was expired.
Other recalls by B. Braun Medical Inc
All 2020 recalls
Class I · High risk
0.9% Sodium Chloride Injection
Presence of Particulate Matter: particulate matter identified as iron oxide, inorganic material, cellulose cotton fiber or polystyrene
Class I · High risk
Lactated Ringer's Injection USP
Presence of Particulate matter.
Class I · High risk
Lactated Ringer's Injection USP
Presence of Particulate Matter.
Class II · Moderate risk
Lactated Ringer's Irrigation
Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.
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