Amphotericin B Liposome for Injection, 50mg vials, 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 62756-233-01
Reported: May 15, 2024 Initiated: April 19, 2024 #D-0493-2024
Product Description
Amphotericin B Liposome for Injection, 50mg vials, 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 62756-233-01
Reason for Recall
Out of specification for assay
Details
- Recalling Firm
- SUN PHARMACEUTICAL INDUSTRIES INC
- Units Affected
- 11,016 vials
- Distribution
- Nationwide within the United States
- Location
- Princeton, NJ
Frequently Asked Questions
What product was recalled? ▼
Amphotericin B Liposome for Injection, 50mg vials, 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 62756-233-01. Recalled by SUN PHARMACEUTICAL INDUSTRIES INC. Units affected: 11,016 vials.
Why was this product recalled? ▼
Out of specification for assay
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on May 15, 2024. Severity: Moderate. Recall number: D-0493-2024.
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