Class I · High risk
Cyclophosphamide for Injection
Presence of Particulate Matter; identified as stainless steel
Cyclophosphamide 840 MG / 250 ML NS IVPB
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of Assurance of Sterility
Cause type: Sterility / contamination
A product that must be sterile could not be assured sterile, or was contaminated. A top reason for injectables, eye drops and IV products - loss of sterility assurance can lead to serious infections. All sterility / contamination recalls.
What was recalled
Cyclophosphamide 840 MG / 250 ML NS IVPB; Cyclophosphamide 1112 MG / 250 ML NS IVPB; Cyclophosphamide 1248 MG / 50 ML NS IVPB; Cyclophosphamide 1125 MG / 100 ML NS IVPB; Cyclophosphamide 1000 MG / 500 ML NS IVPB; Cyclophosphamide 1400 MG / 100 ML NS IVPB Cyclophosphamide 1056 MG / 250 ML NS IVPB; Cyclophosphamide 980 MG / 500 ML NS IVPB; Cyclophosphamide 580 mg / 500 ML NS IVPB; Cyclophosphamide 880 MG / 500 ML NS IVPB; Cyclophosphamide 501 MG / 250 ML NS IVPB; Cyclophosphamide 1163 MG / 50 ML NS IVPB Cyclophosphamide 1100 MG / 500 ML NS IVPB; Cyclophosphamide 1152 MG / 250 ML NS IVPB; Cyclophosphamide 1116 MG / 250 ML NS IVPB Cyclophosphamide 894 MG / 250 ML NS IVPB; Cyclophosphamide 1210 MG / 500 ML NS IVPB; Cyclophosphamide 1010 MG/ 500 ML NS IVPB Cyclophosphamide 1030 MG / 500 ML NS IVPB; Cyclophosphamide 500 MG / 250 ML NS IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233
Drug: Cyclophosphamide
- Recalling firm
- Infusion Options, Inc.
- Origin
- NY, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1761-2019 · 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 Infusion Options, Inc.
All 2019 recalls
Class II · Moderate risk
FERRIC CARBOXYMALTOSE 750mg/50ml NS IVPB
Lack of Assurance of Sterility
Class II · Moderate risk
Vincristine 1 Mg /50 Ml Ns Ivpb
Lack of Assurance of Sterility
Class II · Moderate risk
Vinblastine 10.9 Mg / 100 Ml D5w Ivpb
Lack of Assurance of Sterility
Class II · Moderate risk
VELCADE 2.1 mg / 0.84 ml SQ SYRINGE
Lack of Assurance of Sterility
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