Class II · Moderate risk
Amphotericin B Liposome for Injection
Out of specification for assay
Amphotericin B Liposome for Injection
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Subpotent drug
Cause type: Wrong potency / content
Sub- or super-potent product, or a failed content-uniformity / assay test. You may receive too little or too much active ingredient - a direct dosing risk. All wrong potency / content recalls.
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
Affected NDC
62756-0233-01
Compare with the code on your package — it is the most precise check available.
Drug: Amphotericin
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 |
|---|---|---|---|---|
| Amphotericin B NDC 62756-0233 |
50 mg/1 | Injectable, Liposomal Intravenous |
Sun Pharmaceutical Industries, Inc. | Rx |
- 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 · 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 Amphotericin recalls
See all
Class II · Moderate risk
Abelcet (Amphotericin B Lipid Complex)
Lack of assurance of sterility: Medial fill with presence of Cupriavidus pauculus.
Class II · Moderate risk
CSF-HC Otic Insufflation Capsule
CGMP Deviations
Class II · Moderate risk
CSF Otic Insufflation Capsule
CGMP Deviations
Class II · Moderate risk
Amphotericin B 0.15% Eye Drops
Lack of sterility assurance.
Other recalls by Sun Pharmaceutical Industries INC
All 2023 recalls
Unclassified
Nystatin Cream
Failed Stability Specifications
Class II · Moderate risk
Carbamazepine Tablets
CGMP Deviations; black spots found on tablets from burnt excipient during manufacturing
Class II · Moderate risk
Perampanel CIII Tablets
Labeling: Label Mix-up: 10mg Perampanel CIII tablet was found in a Perampanel CIII bottle labeled Perampanel 6 mg tablets.
Class III · Low risk
Fexofenadine Hydrochloride Tablets
Failed Impurities/Degradation Specifications
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