Home / Recalls / Ascend Laboratories, LLC / D-0339-2024

D-0339-2024 Class II Ongoing

Recalled by Ascend Laboratories, LLC — Parsippany, NJ

Recall Details

Product Type
Drugs
Report Date
February 28, 2024
Initiation Date
January 16, 2024
Termination Date
N/A
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.

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  • D-0020-2026 Class II — Atorvastatin Calcium Tablets USP, 80 mg, Rx Only, a). 90-count(NDC 67877-514-90) (September 19, 2025)
  • D-0019-2026 Class II — Atorvastatin Calcium Tablets USP, 20 mg, Rx Only, a). 90-count(NDC 67877-512-90) (September 19, 2025)
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  • D-0534-2025 Class II — Rizatriptan Benzoate Tablets, USP, 10 mg, 18 (3x6) Unit Dose Tablets, Rx Only, M (July 9, 2025)
  • D-0533-2025 Class II — Rizatriptan Benzoate Tablets, USP, 5 mg, 18 (3x6) Unit Dose Tablets, Rx Only, Ma (July 9, 2025)
  • D-0469-2025 Class II — Cephalexin for Oral Suspension, USP, 125 mg per 5 mL, 200 mL (when mixed), Rx On (May 23, 2025)
  • D-0468-2025 Class II — Cephalexin for Oral Suspension, USP, 125 mg per 5 mL, 100 mL (when mixed), Rx On (May 23, 2025)