Class I · High risk Ongoing
Cyclophosphamide for Injection
Reason Presence of Particulate Matter; identified as stainless steel
Cyclophosphamide 50 mg cap NDC 00054-0383-25 28 days supply
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of Processing Controls.
What was recalled
Cyclophosphamide 50 mg cap NDC 00054-0383-25 28 days supply
- Recalling firm
- Kroger Specialty Pharmacy, Inc.
- NDC code
- 00054-0383-25
- Origin
- MS, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0785-2018
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Cyclophosphamide recalls
See all
Class I · High risk Ongoing
Cyclophosphamide for Injection
Reason Presence of Particulate Matter; identified as stainless steel
Class II · Moderate risk Ongoing
Cyclophosphamide Injection 500 mg/5 mL
Reason cGMP deviations: Temperature excursion during transportation.
Class III · Low risk Terminated
Cyclophosphamide for Injection
Reason Labeling: Incorrect or missing Package Insert: There is an error on the Package Insert (PI), section 2.3, Preparation, Handling, and Administration. The concentration of the reconstituted product is listed as '20 mg per vial.' This information should read: '20 mg per mL'.
Class III · Low risk Terminated
Cyclophosphamide for Injection
Reason Labeling: Incorrect or missing Package Insert: There is an error on the Package Insert (PI), section 2.3, Preparation, Handling, and Administration. The concentration of the reconstituted product is listed as '20 mg per vial.' This information should read: '20 mg per mL'.
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