AmBisome 50 mg per 12.5 mL injection, powder, lyophilized, for solution

Where it's made

This label doesn't name the factory that makes the drug. Companies don't have to print it on the label. The maker's name is often on the stock bottle your pharmacy used; you can ask the pharmacist. See the plants Astellas Pharma US, Inc. names for other drugs.

Recalls

• Jun 20, 2013 · Class II · Gilead Sciences, Inc.
  Lack of Sterility Assurance; During a routine simulation of the manufacturing of AmBisome, a bacterial contamination was detected in some media fill units. No contaminated batches have actually been identified in the finished product, but there is a possibility of contamination.
  Lots: 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, 042293AK, 042298AD, Exp 09/…
• Jun 19, 2013 · Class II · Astellas Pharma US Inc
  Lack of Assurance of Sterility; Astellas Pharma US, Inc. is performing a voluntary recall on certain lots of AmBisome because the manufacturer has notified Astellas that during a routine simulation of the manufacturing of AmBisome, a bacterial contamination was detected in the media fills.
  Lots: Lot #: 042267AA, Exp July 2015, 042287AA, 042289AA, 042291AA, Exp Aug 2015. Lot Numbers and Expiry Dates (for Canada distribution). LOT 042269AA, EXP 07/2015, LOT 0422C1AA, EXP 11/2015.

Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.

Product details

Generic drug

Amphotericin B: every company that makes it

Form

injection, powder, lyophilized, for solution

Strength

50 mg per 12.5 mL

Approval

NDA NDA050740

On the market since

Aug 11, 1997

Package NDCs

0469-3051-30

Official label

DailyMed (National Library of Medicine), updated Oct 2, 2026

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