Class III · Low risk Ongoing
Primidone Tablets
Reason Cross Contamination with Other Products: due to a potential for cross-contamination with Acemetacin API due to an issue at the API manufacturer.
Zoledronic Acid Injection 5 mg per 100 mL
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of Assurance of Sterility; leaking of premix bags
What was recalled
Zoledronic Acid Injection 5 mg per 100 mL (0.05 mg/mL), 100 mL single-use bag packaged in a foil overwrap, Rx only, Sterile, For Intravenous Infusion, Mfd. for Sagent Pharmaceuticals Schaumburg, IL ---- NDC 25021-830-82
- Recalling firm
- Sagent Pharmaceuticals Inc
- NDC code
- 25021-830-82
- Origin
- IL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1615-2014
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 Sage recalls
See all
Class III · Low risk Ongoing
Busulfan Injection
Reason Failed Impurities/Degradation Specifications
Class II · Moderate risk Ongoing
chlorproMAZINE Hydrochloride Tablets
Reason Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
Class II · Moderate risk Ongoing
chlorproMAZINE Hydrochloride Tablets
Reason Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
Class II · Moderate risk Ongoing
chlorproMAZINE Hydrochloride Tablets
Reason Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
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