Prescription injection recalled for failed stability test results
Teva Pharmaceuticals is recalling Granix injection due to failed stability test results showing one peptide did not meet specification limits.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II designation with failed stability specifications for a prescription injectable drug represents a risk-of-harm situation where no illnesses or injuries have been reported. The failed stability test indicates the product may not maintain proper potency or acceptable stability characteristics over its shelf life.
Plain-English summary
Teva Pharmaceuticals USA, Inc. is recalling certain batches of Granix (tbo-filgrastim) Injection 300 mcg/0.5 mL. A 12-month stability test revealed that one of the known peptides in the affected product fell below the specification limit.
The recall includes 34,636 cartons that were distributed nationwide. The affected lot numbers are 135738, 137149, and 137148, each with an expiration date of 09/30/2025.
Granix is a prescription injectable medication. The FDA classified this as a Class II recall. The product was manufactured by UAB Teva Baltics in Lithuania and distributed by Teva Pharmaceuticals USA, Inc.
The recalled product
- Product
- GRANIX (TBO-FILGRASTIM)
- Brand
- GRANIX
- Manufacturer
- Teva Pharmaceuticals USA, Inc
- Category
- Drug — Injectable Growth Factor
- Affected units
- 34,636
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 (4)
- Lot # (a) 135738
- (b) 137149
- (c) 137148
- Exp. date 09/30/2025
Distribution
Distributed nationwide across the United States.
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