Class II · Moderate risk Ongoing
Amphotericin B Liposome for Injection, 50mg vials, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ…
Reason Out of specification for assay
Amphotericin B Liposome for Injection, 50mg/vial, Rx only, Distributed by Sun…
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Subpotent drug
What was recalled
Amphotericin B Liposome for Injection, 50mg/vial, Rx only, Distributed by Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Manufactured by Sun Pharmaceutical Medicare Limited, Baska Ujeti Road, Ujeti, Halol-389350, Gujarat, India, NDC 62756-0233-01
- Recalling firm
- Sun Pharmaceutical Industries INC
- NDC code
- 62756-0233-01
- Origin
- NJ, United States
- Initiated by
- N/A
- FDA recall number
- D-0891-2023
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 Amphotericin recalls
See all
Class II · Moderate risk Terminated
Abelcet (Amphotericin B Lipid Complex) Injection, 5 mg/mL, 100 mg vial, Rx only, Manufactured by Exelead, Inc., Indianapolis, IN…
Reason Lack of assurance of sterility: Medial fill with presence of Cupriavidus pauculus.
Class II · Moderate risk Terminated
CSF-HC Otic Insufflation Capsule, Sulfacetamide Sodium/Ciprofloxacin/Hydrocortisone/Amphotericin B Otic Powder, 50mg/ 30mg/ 25mg/…
Reason CGMP Deviations
Class II · Moderate risk Terminated
CSF Otic Insufflation Capsule, Sulfacetamide Sodium/ Ciprofloxacin/ Amphotericin B Otic Powder, 50mg / 30mg / 5mg, 5 count…
Reason CGMP Deviations
Class II · Moderate risk Terminated
Amphotericin B 0.15% Eye Drops, 2 mL Droppers, Anderson Compounding Pharmacy 310 Bluff City Hwy Bristol, TN.
Reason Lack of sterility assurance.
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