Recalls / Class II
Class IID-0493-2024
Product
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
- Brand name
- Amphotericin B
- Generic name
- Amphotericin B
- Active ingredient
- Amphotericin B
- Route
- Intravenous
- NDC
- 62756-233
- FDA application
- ANDA212514
- Affected lot / code info
- Lot #: BAE0055A, BAE0056A, BAE0068A, Exp. Date 03/2026
Why it was recalled
Out of specification for assay
Recalling firm
- Firm
- SUN PHARMACEUTICAL INDUSTRIES INC
- Manufacturer
- Sun Pharmaceutical Industries, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 2 Independence Way, N/A, Princeton, New Jersey 08540-6620
Distribution
- Quantity
- 11,016 vials
- Distribution pattern
- Nationwide within the United States
Timeline
- Recall initiated
- 2024-04-19
- FDA classified
- 2024-05-08
- Posted by FDA
- 2024-05-15
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0493-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.