Reported Feb 12, 2025 · Ongoing

Granix (tbo-filgrastim) Injection 300 mcg/0.5 mL, Single Dose prefilled syringe, packaged as a) 1 syringe in 1 CARTON,…

Teva Pharmaceuticals USA, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Teva Pharmaceuticals USA, Inc · 400 Interpace Pkwy Bldg A · Parsippany, NJ · 07054-1120

Is this the product you have?

  • Granix (tbo-filgrastim) Injection 300 mcg/0.5 mL, Single Dose prefilled syringe, packaged as a) 1 syringe in 1 CARTON, NDC 63459-910-11, Blister NDC 63459-910-12; (b)10 syringes in 1 CARTON, NDC 63459-910-15, Blister NDC 63459-910-12; (c) 1 syringe in 1 CARTON, NDC 63459-910-17 without safety guard and blister, Rx Only
  • Manufactured byUAB Teva Baltics, Vilnius, Lithuania. Distributed by Teva Pharmaceuticals USA, Inc. North Wales PA 19454. Product of Israel
Lot codes and dates
    • Lot # (a) 135738
    • (b) 137149
    • (c) 137148
    • Exp. date 09/30/2025
Amount recalled
34,636 cartons

Where it was sold

  • Nationwide

Why it was recalled

Failed Stability Specifications - 12-month stability test result for one of the known peptides is below the specification limit

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Data as of Sep 19, 5:08 PM UTC

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