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
Reported: February 28, 2024 Initiated: January 16, 2024 #D-0339-2024
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
Details
- Recalling Firm
- Ascend Laboratories, LLC
- Units Affected
- 71,244 sachets
- Distribution
- Nationwide in the USA
- Location
- Parsippany, NJ
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Ascend Laboratories, LLC. Units affected: 71,244 sachets.
Why was this product recalled? ▼
Failed Impurities/Degradation Specification: Out of specification for organic impurities
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on February 28, 2024. Severity: Moderate. Recall number: D-0339-2024.
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