Fosfomycin Tromethamine Granules for Oral Solution recall
FDA recall D-0339-2024 · initiated Jan 16, 2024
Ascend Laboratories, LLC recalled Fosfomycin Tromethamine Granules for Oral Solution in Jan 2024 — an FDA Class II recall (D-0339-2024) because Failed Impurities/Degradation Specification: Out of specification for organic impurities.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Failed Impurities/Degradation Specification: Out of specification for organic impurities
An impurity above the accepted limit
A by-product of manufacturing or storage exceeded the limit the FDA accepts. Nitrosamines are the common example: the concern is long-term exposure, not immediate danger from one dose.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 71,244 sachets
Details
- Product
- Fosfomycin Tromethamine Granules for Oral Solution, (equivalent to 3 grams of fosfomycin), single-dose sachet, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA. Distributed by: Ascend Laboratories, LLC. Parsippany, NJ 07054. NDC 67877-749-57
- Recalling company
- Ascend Laboratories, Ltd
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide in the USA
- Initiated
- Jan 16, 2024
- FDA report date
- Feb 28, 2024
Frequently asked
- Was Fosfomycin Tromethamine Granules for Oral Solution recalled?
- Ascend Laboratories, LLC recalled Fosfomycin Tromethamine Granules for Oral Solution in Jan 2024 — an FDA Class II recall (D-0339-2024) because Failed Impurities/Degradation Specification: Out of specification for organic impurities. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Fosfomycin Tromethamine Granules for Oral Solution recalled?
- Per the FDA enforcement record, the reason for recall D-0339-2024 was: Failed Impurities/Degradation Specification: Out of specification for organic impurities
- Is a recalled Fosfomycin Tromethamine Granules for Oral Solution dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Fosfomycin Tromethamine Granules for Oral Solution are affected?
- Distributed: Nationwide in the USA. The recall covers these lots — 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.. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0339-2024.