FDA DrugsClass II
DULOXETINE D/R, a) 30 mg (NDC 61919-482-30), 30 Caps; b) 30 mg (NDC 61919-482-60...
Published: July 1, 2026Recall ID: D-0617-2026Category: drugsCountry: US
Reason for Recall / Hazard
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Product Description & Identification
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.
Additional Source Details
| Field | Value |
|---|---|
| City | Dawsonville |
| State | GA |
| Event id | 99269 |
| Address 1 | 94 Worldwide Dr |
| Address 2 | N/A |
| Code info | Lot: a) 09JA2530, 31JA2507, expires: 04/30/2027; b) Lot: 09DE2412, 09JA2528, 29JA2511, expires: 04/30/2027. |
| Postal code | 30534-6828 |
| Report date | 20260701 |
| Product type | Drugs |
| Product quantity | 263 Bottles |
| Reason for recall | CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260622 |
| Initial firm notification | Letter |
| Center classification date | 20260623 |
Overview
- Recalling FirmDirect Rx
- StatusOngoing
- Risk LevelClass II
- DistributionU.S. Nationwide