[pending] Duloxetine D/R, 30 mg, 30 Caps, RX Only, Packaged as a) 30-count bottle NDC 61919-0482-30, b) 60-cou
Pending LLM rewrite. Source: FDA_DRUG D-0568-2025.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
The recalled product
- Product
- Duloxetine D/R, 30 mg, 30 Caps, RX Only, Packaged as a) 30-count bottle NDC 61919-0482-30, b) 60-count bottle, NDC 61919-0482-60, c) 90-count bottle, NDC 61919-0482-90; Packaged & Distributed by: Direct Rx, Dist. By Breckenridge Pharm., Inc., Berlin, CT 06037,
- Manufacturer
- Direct Rx
- Category
- Drug — Drugs
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Lot #: a) 15AU2420
- 01JY2407
- 04OC2411
- Exp 01/31/2027
- 12SE2418
- 24OC2424
- 20NO2416
- Exp 03/31/2027
- 21AU2313
- 21JY2311
- 05JY2313
- Exp Date 01/31/2026 b) 13OC2310
- 05SE2304
- 04AU2306
- 21JY2317
- 12JY2306
- Exp 01/31/2026
- 11JY2416
- 28JU2414
- 19AU2412
Distribution
Distributed nationwide across the United States.
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