Fosfomycin Tromethamine Granules Recalled for Out-of-Specification Organic Impurities
Ascend Laboratories recalls 71,244 sachets of Fosfomycin Tromethamine for failing quality specifications due to organic impurities. Patients with affected lots should consult their healthcare provider.
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 recall for a pharmaceutical product with out-of-specification organic impurities. Although no illnesses or injuries have been reported, this represents a risk-of-harm medication where potential injury has not yet occurred, per the rubric criterion for Score 3.
Plain-English summary
Fosfomycin Tromethamine Granules for Oral Solution (3 grams per sachet), manufactured by Alkem Laboratories Ltd., India, and distributed by Ascend Laboratories, LLC, is being recalled nationwide in the United States.
The recall affects 71,244 sachets. The affected product lots failed quality specifications due to the presence of organic impurities. The affected lot numbers are: 22121458, 22121459, 22121460, 22121461, 22121462, 22121463, 22121464 (expiration 4/2024); 22121176, 22121407, 22121465 (expiration 3/2024); 22121761, 22121762, 22121763, 22121764, 22121766, 22121968, 22121969 (expiration 5/2024). The product NDC is 67877-749-57.
Patients who have received this medication and are taking one of the affected lots should contact their pharmacist or healthcare provider for guidance on their treatment.
The recalled product
- Product
- FOSFOMYCIN TROMETHAMINE (FOSFOMYCIN TROMETHAMINE)
- Brand
- FOSFOMYCIN TROMETHAMINE
- Manufacturer
- Ascend Laboratories, LLC
- Category
- Drug — Prescription Antibiotic
- Affected units
- 71,244
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 (20)
- lOTS #: 22121458
- 22121459
- 22121460
- 22121461
- 22121462
- 22121463
- 22121464
- Exp 4/2024
- 22121176
- 22121407
- 22121465
- Exp 3/2024
- 22121761
- 22121762
- 22121763
- 22121764
- 22121766
- 22121968
- 22121969
- Exp 5/2024.
UPCs (1)
- 0367877749570
Distribution
Distributed nationwide across the United States.
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