D-0617-2026 Class II Ongoing
FDA drug recall D-0617-2026 was initiated by Direct Rx on June 22, 2026 and is designated Class II. Reason for recall: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit The recall status is ongoing. Affected quantity: 263 Bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- July 1, 2026
- Initiation Date
- June 22, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 263 Bottles
Product Description
DULOXETINE D/R, a) 30 mg (NDC 61919-482-30), 30 Caps; b) 30 mg (NDC 61919-482-60), 60 Caps; CYMBALTA, Packaged and Distributed by Direct Rx.
Reason for Recall
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Distribution Pattern
U.S. Nationwide
Code Information
Lot: a) 09JA2530, 31JA2507, expires: 04/30/2027; b) Lot: 09DE2412, 09JA2528, 29JA2511, expires: 04/30/2027.