FDAHealthNovember 14, 2024
Amerisource Health Services LLC — Duloxetine Delayed-Release Capsules, USP, 30 mg, Rx only, a) 30 count (NDC 68001-414-04) and b) 1,000 count (NDC 68001-414-08) bottles, Manufactured by: Aurobindo Pha
⚠️ CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit
Is this relevant to me?
- Geography
- PA, OH, PR
- Source agency
- FDA
- Category
- Health
- Published
- November 14, 2024
PA, OH, PR
What's affected?
- Product
- Duloxetine Delayed-Release Capsules, USP, 30 mg, Rx only, a) 30 count (NDC 68001-414-04) and b) 1,000 count (NDC 68001-414-08) bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories
- Lot code
- a) 30 count; Lot, expiry: DT3023019B, DT3023020A, exp 01/31/2025 b) 1000 count; Lot, expiry: DTB23098A, exp 08/31/2025
Additional details
a) 30 count; Lot, expiry: DT3023019B, DT3023020A, exp 01/31/2025 b) 1000 count; Lot, expiry: DTB23098A, exp 08/31/2025
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 23,490 bottles.
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