Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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National Drug Code

Is NDC 60505-6197-02 recalled?

Sirolimus · 1 BOTTLE, GLASS in 1 CARTON (60505-6197-2) / 60 mL in 1 BOTTLE, GLASS

Yes — this exact package was recalled

1 FDA recall names the code 60505-6197-02 directly. A recall still applies to particular lot numbers — compare the lot on your package with the FDA notice below, and talk to your pharmacist before stopping a prescribed medication.

Active ingredient
Sirolimus
Strength
SIROLIMUS 1 mg/mL
Form
Solution · Oral
Labeler
Apotex Corp
Type
Human Prescription Drug
Product code
60505-6197

Recalls naming this package

Class III ยท Low risk

Sirolimus Oral Solution

Failed Dissolution Specifications: Sirolimus Oral Solution recalled due to lot RZ1598 exceeded the specification limit at the 14-month timepoint.

Terminated Dissolution failure Apotex Corp. NDC 60505-6197-2 D-0881-2022

Where to find this code. The NDC is printed on the pharmacy label and on the manufacturer's carton, usually as three groups of digits after “NDC”. The last group is the package size — two bottles of the same medicine can differ only in that group, and a recall may cover one but not the other.

Other recalled products from this labeler