Astellas Recalls AmBisome Injection Lots Due to Sterility Concerns
Astellas Pharma US is voluntarily recalling specific lots of AmBisome (amphotericin B) liposome for injection because a routine simulation detected bacterial contamination.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk of bacterial contamination in a sterile injectable product, which aligns with the 'Severe' criteria for significant injury risk or Class II classifications with potential for serious harm.
Plain-English summary
Astellas Pharma US, Inc. is performing a voluntary recall of certain lots of AmBisome (amphotericin B) liposome for injection. The recall is being conducted because the manufacturer, Gilead Sciences, Inc., notified Astellas that bacterial contamination was detected in media fills during a routine simulation of the manufacturing process.
The affected product is AmBisome (amphotericin B) liposome for injection, 50mg vial, single use vial, intended for intravenous infusion only. The recall covers 133,550 vials distributed nationwide and in Canada. Specific lot numbers and expiration dates are listed in the recall documentation, including lots expiring in July and August 2015, as well as lots for Canada distribution expiring in July and November 2015.
Healthcare providers and patients should check their inventory and medication records for the specific lot numbers and expiration dates listed in the official recall notice. If you have been administered a vial from an affected lot, contact your healthcare provider for guidance. Do not use any remaining vials from the affected lots.
The recalled product
- Product
- AmBisome (amphotericin B) liposome for injection, 50mg vial, single use vial, For Intravenous Infusion Only, 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
- Astellas Pharma US Inc
- Category
- Drug — Injectable Antifungal
- Affected units
- 133,550
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 (8)
- Lot #: 042267AA
- Exp July 2015
- 042287AA
- 042289AA
- 042291AA
- EXP 07/2015
- LOT 0422C1AA
- EXP 11/2015.
Distribution
Distributed nationwide across the United States.
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