Fosfomycin Tromethamine Granules for Oral Solution recall: Impurity Out of Spec
Fosfomycin Tromethamine Granules for Oral Solution, 3 g single- dose sachet, Rx only, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054, NDC# 67877-749-57
Why was Fosfomycin Tromethamine Granules for Oral Solution recalled?
Failed Impurities/Degradation Specifications: Out-of-specification results observed for the organic impurities test at 6 months, RT Stability.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot #22121970, 22122158, 22121971, 22122189, 22122190, 22122277, 22122278, Exp June 2024; 22122521, 22122522, 22122523, Exp July 2024; 22123328, 22123329, 22123330, Exp September 2024.
- Product
- Fosfomycin Tromethamine Granules for Oral Solution, 3 g single- dose sachet, Rx only, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054, NDC# 67877-749-57
- Recalling firm
- Ascend Laboratories, LLC
- Quantity
- 99,516 sachets
- Distribution
- The recall product was distributed nationwide.
- Recall date
- September 13, 2023
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (drug)