Class I · High risk
Cyclophosphamide for Injection
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.
Cause type: cGMP deviation
Departures from current Good Manufacturing Practice found in production or during FDA inspection. A broad quality-system cause: the batch was made under conditions that fall short of FDA manufacturing standards. All cgmp deviation recalls.
What was recalled
Cyclophosphamide 50 mg cap NDC 00054-0383-25 28 days supply
Affected NDC
0054-0383-25
Compare with the code on your package — it is the most precise check available.
Drug: Cyclophosphamide
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Cyclophosphamide NDC 00054-0383 |
50 mg/1 | Capsule Oral |
Hikma Pharmaceuticals USA Inc. | Rx |
- 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 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Cyclophosphamide recalls
See all
Class I · High risk
Cyclophosphamide for Injection
Presence of Particulate Matter; identified as stainless steel
Class II · Moderate risk
Cyclophosphamide Injection 500 mg/5 mL
cGMP deviations: Temperature excursion during transportation.
Class III · Low risk
Cyclophosphamide for Injection
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
Cyclophosphamide for Injection
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'.
Other recalls by Kroger Specialty Pharmacy, Inc.
All 2018 recalls
Class II · Moderate risk
Lupron Depot 22.5 mg 3 month Kit NDC 00074-3346-03 84 days supply
Lack of Processing Controls.
Class II · Moderate risk
Kisqali 600 Dose 63 tablet 200 mg NDC 00078-0874-63 28 days supply
Lack of Processing Controls.
Class II · Moderate risk
OPDIVO 40 mg/4 mL SDV NDC 00003-3772-11 28 days supply
Lack of Processing Controls.
Class II · Moderate risk
Tasigna Capsules 150 mg NDC 00078-0592-87 28 days supply
Lack of Processing Controls.
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