Gilead Recalls AmBisome Injection Due to Potential Sterility Assurance Issues
Gilead Sciences is recalling 478,352 vials of AmBisome (amphotericin B) liposome for Injection due to a lack of sterility assurance detected during routine manufacturing simulations.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (potential bacterial contamination) where injury has not yet been reported, which aligns with the 'High' severity criteria for theoretical hazards without confirmed illness.
Plain-English summary
Gilead Sciences, Inc. is recalling 478,352 vials of AmBisome (amphotericin B) liposome for Injection, 50 mg, for intravenous infusion only. The product is marketed by Astellas Pharma US, Inc. and manufactured by Gilead Sciences, Inc. The recall involves specific lots with expiration dates ranging from June 2015 to January 2017.
The recall was initiated due to a lack of sterility assurance. During a routine simulation of the manufacturing process, bacterial contamination was detected in some media fill units. The source text states that no contaminated batches have been identified in the finished product, but there is a possibility of contamination.
The affected product was distributed only to foreign locations, including France, Italy, Switzerland, Portugal, Denmark, Turkey, Ireland, Norway, Malta, UK, Greece, Belgium, Austria, Germany, India, Hong Kong, Israel, Saudi Arabia, Thailand, UAE, Singapore, Ecuador, Oman, El Salvador, MCF Holland, MSF, Ethiopia, Egypt, Argentina, Chile, Brazil, Spain, Finland, and Sweden. Consumers and healthcare providers should stop using the affected lots and contact their healthcare provider or the manufacturer for further instructions.
The recalled product
- Product
- AmBisome (amphotericin B) liposome for Injection, 50 mg, For Intravenous Infusion Only, Single-Use Vial, Rx Only, Marketed by: Astellas Pharma US, Inc., Northbrook, IL 60062, Manufactured by: Gilead Sciences, Inc., San Dimas, CA 91773, NDC 0469-3051-30.
- Manufacturer
- Gilead Sciences, Inc.
- Category
- Drug — Antifungal
- Affected units
- 478,352
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Lot #: 042262AD
- 042262AD1
- 042263AD
- 042263AD1
- 042264AD
- 042265AD
- 042265AD1
- 042265AD2
- Exp 06/2015
- 42269AK
- 042270AD
- 042270AD1
- 042270AD3
- 042270AD4
- 042273AD
- Exp 07/2015 and 07/2016 (Germany only)
- 042285AD
- Exp 08/2015 and 8/2016 (UK only)
- 042293AA
- 042293AE
Distribution
Distribution scope not specified by the agency.
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