Fosfomycin Tromethamine Antibiotic Recalled for Failed Stability Specifications
Ascend Laboratories is recalling Fosfomycin Tromethamine antibiotic granules nationwide due to organic impurities exceeding acceptable levels in stability testing. No illnesses have been reported.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class III recall involving failed pharmaceutical stability and impurity specifications with no reported illnesses or injuries. FDA Class III recalls are typically scored as 1 or 2, and this product-quality issue warrants Moderate severity.
Plain-English summary
Ascend Laboratories, LLC is recalling Fosfomycin Tromethamine Granules for Oral Solution (3 g single-dose sachets) distributed nationwide. The product is a prescription antibiotic manufactured by Alkem Laboratories Ltd. in India and distributed under NDC# 67877-749-57.
The recall was initiated because stability testing at six months revealed out-of-specification results for organic impurities. Testing at room temperature failed to meet established degradation specifications.
The recall affects specific lot numbers with expiration dates from June 2024 through September 2024: lots 22121970, 22122158, 22121971, 22122189, 22122190, 22122277, 22122278 (June 2024); lots 22122521, 22122522, 22122523 (July 2024); and lots 22123328, 22123329, 22123330 (September 2024). Patients taking this medication should contact their healthcare provider or pharmacist regarding their specific supply.
The recalled product
- Product
- FOSFOMYCIN TROMETHAMINE (FOSFOMYCIN TROMETHAMINE)
- Brand
- FOSFOMYCIN TROMETHAMINE
- Manufacturer
- Ascend Laboratories, LLC
- Affected units
- 99,516
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 (16)
- Lot #22121970
- 22122158
- 22121971
- 22122189
- 22122190
- 22122277
- 22122278
- Exp June 2024
- 22122521
- 22122522
- 22122523
- Exp July 2024
- 22123328
- 22123329
- 22123330
- Exp September 2024.
UPCs (1)
- 0367877749570
Distribution
Distributed nationwide across the United States.
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