FDA-Drug2025-11-05Class IICHEMICAL
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
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.
Intended for
Adults
Illnesses reported
None reported
Sold states
U.S. Nationwide
Affected count
181,659 bottles
Manufactured in
400 Interpace Pkwy Bldg A, N/A, Parsippany, NJ, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0104-2026More Teva recalls
- FDA-Drug2026-09-09Teva trazodone 50 mg tablets recalled for foreign tablets in bottles
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