FDARecalled Aug 13, 2025 · #D-0568-2025
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:...
Hazard
Class II — temporary health risk
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CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit. Classification: Class II Distribution: Nationwide
Product details
- 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,
- Type
- Drugs
- Manufacturer
- Direct Rx
- Model numbers
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- UPCs
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