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
Reported: September 13, 2023 Initiated: July 18, 2023 #D-1145-2023
Product Description
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
Reason for Recall
Failed Impurities/Degradation Specifications: Out-of-specification results observed for the organic impurities test at 6 months, RT Stability.
Details
- Recalling Firm
- Ascend Laboratories, LLC
- Units Affected
- 99,516 sachets
- Distribution
- The recall product was distributed nationwide.
- Location
- Parsippany, NJ
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Ascend Laboratories, LLC. Units affected: 99,516 sachets.
Why was this product recalled? ▼
Failed Impurities/Degradation Specifications: Out-of-specification results observed for the organic impurities test at 6 months, RT Stability.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on September 13, 2023. Severity: Low. Recall number: D-1145-2023.
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