Teva Pharmaceuticals USA, Inc: Prazosin Hydrochloride, Capsules, USP, 5 mg, Rx only, Distributed by TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, a) 100 Capsules,
Read the official notice at FDA (drug) →
Get alerts for Teva Pharmaceuticals
The text below is copied from the official FDA (drug) record. If anything differs, the official notice is correct.
- Company / brand
- Teva Pharmaceuticals USA, Inc
- Product
- Prazosin Hydrochloride, Capsules, USP, 5 mg, Rx only, Distributed by TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, a) 100 Capsules, NDC 0093-4069-01, b) 250 Capsules, NDC 0093-4069-52, c) 500 Capsules, NDC 0093-4069-05
- Reason / 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.
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- U.S. Nationwide
- Recall initiated
- 2025-10-07
- Code info
- a) NDC 0093-4069-01: Lot # 3010403A, 3010385A, 3010404A, Exp Date: 02/2026; Lot # 3010405A, 3010510A, 3010528A, 3010354A, Exp Date: 03/2026; Lot # 3010592A, 3010605A, 3010611A, 3010612A, Exp Date: 08/2026; Lot # 3010655A, 3010703A, Exp Date: 02/2027 b) NDC 0093-4069-52: Lot # 3010430A, Exp Date: 11/2025, Lot # 3010613A, Exp Date: 08/2026 c) NDC 0093-4069-05: Lot # 3010406A, Exp Date: 02/2026
- Product quantity
- 107,673
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Parsippany
- State
- NJ
- Country
- United States
- Event id
- 97755
Free daily digest + "My products" watchlist