D-0339-2024 Class II Ongoing
FDA drug recall D-0339-2024 was initiated by Ascend Laboratories, LLC on Jan 16, 2024 and is designated Class II. Reason for recall: Failed Impurities/Degradation Specification: Out of specification for organic impurities The recall status is ongoing. Affected quantity: 71,244 sachets.
Recall Details
- Product Type
- Drugs
- Report Date
- Feb 28, 2024
- Initiation Date
- Jan 16, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 71,244 sachets
Product Description
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
Reason for Recall
Failed Impurities/Degradation Specification: Out of specification for organic impurities
Distribution Pattern
Nationwide in the USA
Code Information
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.
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0339-2024
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026