FDARecalled Nov 5, 2025 · #D-0105-2026
Prazosin Hydrochloride, Capsules, USP, 2 mg, Rx only, Distributed by TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, a) 100 Capsules, NDC 0093-4068-01, b) 1000 Capsules, NDC 0093-4068-10
Hazard
Class II — temporary health risk
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CGMP Deviations-Test results for N-nitroso Prazosin impurity C that are above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit for the above specified lots. Classification: Class II Distribution: U.S. Nationwide
Product details
- Product
- Prazosin Hydrochloride, Capsules, USP, 2 mg, Rx only, Distributed by TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, a) 100 Capsules, NDC 0093-4068-01, b) 1000 Capsules, NDC 0093-4068-10
- Type
- Drugs
- Manufacturer
- Teva Pharmaceuticals USA, Inc
- Model numbers
- 0093-4068-01, 0093-4068-10, 3010398A, 3010439A, 3010526A, 3010591A, 3010343A, 3010352A, 3010468A, 3010629A, 3010653A, 3010654A, 3010547A, 3010402A, 3010593A, 3010610A
- UPCs
- —