Class II · Moderate risk
Ganciclovir
Lack of sterility assurance
Cymevene 500 mg Powder for Infusion
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of Assurance of Sterility; container closure issues with the bulk batch.
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
Cymevene 500 mg Powder for Infusion, (ganciclovir), 50 mg/mL ganciclovir (reconstructed), Rx only, 10 mL vials, Roche Products Limited, Welwyn Garden City, AL7 1TW, United Kingdom
Drug: Ganciclovir
- Recalling firm
- F. Hoffmann-LaRoche Ltd.
- Origin
- N/A, Switzerland
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-105-2013 · 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 Ganciclovir recalls
See all
Class II · Moderate risk
Ganciclovir for Injection
Labeling: Label mix-up - one vial was mislabeled as Cladribine Injection 10mg/mL inside a 10-count carton of Ganciclovir 500 mg.
Class II · Moderate risk
GANCICLOVIR in NS
Lack of Assurance of Sterility: Product sterility cannot be guaranteed.
Class II · Moderate risk
Ganciclovir Sodium
Lack of Assurance of Sterility: Sterility of product is not assured.
Class II · Moderate risk
Ganciclovir
Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
Other sterility / contamination recalls from 2012
All sterility / contamination recalls
Class I · High risk
Cyanocobalamin 1000 mcg/ml
Non-Sterility: Green Valley Drugs received positive sterility results from their testing lab on two lots of Methylprednisolone Preservative Free 40 mg/mL injectable suspension and one lot of Cyanocobalamin 1000 mcg/mL injection, 30 mL MDV.
Class I · High risk
Methylprednisolone Preservative Free 40 mg/ml Injectible Suspension
Non-Sterility: Green Valley Drugs received positive sterility results from their testing lab on two lots of Methylprednisolone Preservative Free 40 mg/mL injectable suspension and one lot of Cyanocobalamin 1000 mcg/mL injection, 30 mL MDV.
Class III · Low risk
TORISEL Kit
Lack of Assurance of Sterility; potential that a low level of endotoxins may be present in the diluent vials.
Class II · Moderate risk
Nalbuphine HCl Injection
Lack of Assurance of Sterility: Complains of a loose crimp applied to the fliptop vial; and a missing stopper and flip cap were received and therefore sterility cannot be assured.
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