FDARecalled Nov 5, 2025 · #D-0104-2026
Prazosin Hydrochloride, Capsules, USP, 1 mg, Rx only, Distributed by TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, a) 100 Capsules, NDC 0093-4067-01, b) 1000 Capsules, NDC 0093-4067-10
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, 1 mg, Rx only, Distributed by TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, a) 100 Capsules, NDC 0093-4067-01, b) 1000 Capsules, NDC 0093-4067-10
- Type
- Drugs
- Manufacturer
- Teva Pharmaceuticals USA, Inc
- Model numbers
- 0093-4067-01, 0093-4067-10, 3010544A, 3010567A, 3010590A, 3010601A, 3010652A, 3010678A, 3010440A, 3010672A
- UPCs
- —