Direct Rx: 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.
Read the official notice at FDA (drug) →
The text below is copied from the official FDA (drug) record. If anything differs, the official notice is correct.
- Company / brand
- Direct Rx
- Product
- 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 / hazard
- CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- U.S. Nationwide
- Recall initiated
- 2026-06-22
- Code info
- Lot: a) 09JA2530, 31JA2507, expires: 04/30/2027; b) Lot: 09DE2412, 09JA2528, 29JA2511, expires: 04/30/2027.
- Product quantity
- 263 Bottles
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Dawsonville
- State
- GA
- Country
- United States
- Event id
- 99269
Free daily digest + "My products" watchlist