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Class II · ModerateActive recall

Granix

Could cause temporary or reversible harm; serious harm is unlikely.

Does this affect you?
Check your lot numberLot # (a) 135738, (b) 137149, (c) 137148, Exp. date 09/30/2025
Where it was soldProduct was distributed nationwide.
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

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

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byUAB Teva Baltics, Vilnius, Lithuania. Distributed by Teva Pharmaceuticals USA, Inc. North Wales PA 19454. Product of Israel foreign manufacturer
Brand nameGRANIX
Generic nameTBO-FILGRASTIM
Active ingredient(s)FILGRASTIM
Distributed by / forTeva Pharmaceuticals USA, Inc. North Wales PA 19454. Product of Israel
NDC63459-910-11
Show the full FDA record
Full product labelGranix (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 by: UAB Teva Baltics, Vilnius, Lithuania. Distributed by Teva Pharmaceuticals USA, Inc. North Wales PA 19454. Product of Israel.
Recalling firmTeva Pharmaceuticals USA, Inc
DistributionProduct was distributed nationwide.
Quantity34,636 cartons
Recall initiated2025-01-10
Report date2025-02-12
Recall completed—
Recall numberD-0218-2025
ClassificationClass II
FDA statusOngoing
Origin on fileParsippany NJ United States

Related

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Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.