Drugplain

PRAZOSIN HYDROCHLORIDE 2 mg/1

PRAZOSIN HYDROCHLORIDE · CAPSULE · Alembic Pharmaceuticals Inc.

10 Recalls on Record
Plain English

PRAZOSIN HYDROCHLORIDE is a capsule containing prazosin hydrochloride at 2 mg/1, taken oral. Manufactured by Alembic Pharmaceuticals Inc..

Key Facts

Brand Name
PRAZOSIN HYDROCHLORIDE
Generic Name
PRAZOSIN HYDROCHLORIDE
NDC Code (Product)
62332-692
Manufacturer
Alembic Pharmaceuticals Inc.
Strength
2 mg/1
Dosage Form
CAPSULE
Route
ORAL
Marketing Status
Application #
ANDA217268
Marketing Start
03/09/2023

Recall History

10 Recalls on Record
Class II03/27/2026

Appco Pharma LLC

cGMP deviation: detection of Nitrosamine Drug Substance-Related Impurities, N-nitroso-prazosin impurity C (NNP) above acceptable limits.

OngoingVoluntary: Firm initiated
Class II10/07/2025

Teva Pharmaceuticals USA, Inc

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.

OngoingVoluntary: Firm initiated
Class II03/27/2026

Appco Pharma LLC

cGMP deviation: detection of Nitrosamine Drug Substance-Related Impurities, N-nitroso-prazosin impurity C (NNP) above acceptable limits.

OngoingVoluntary: Firm initiated
Class II10/07/2025

Teva Pharmaceuticals USA, Inc

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.

OngoingVoluntary: Firm initiated
Class II10/16/2025

Amerisource Health Services LLC

Failed Impurities/Degradation Specification: presence of N-nitroso Prazosin impurity C above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit

OngoingVoluntary: Firm initiated
Class II10/16/2025

Amerisource Health Services LLC

Failed Impurities/Degradation Specification: presence of N-nitroso Prazosin impurity C above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit

OngoingVoluntary: Firm initiated
Class II03/27/2026

Appco Pharma LLC

cGMP deviation: detection of Nitrosamine Drug Substance-Related Impurities, N-nitroso-prazosin impurity C (NNP) above acceptable limits.

OngoingVoluntary: Firm initiated
Class II10/16/2025

Amerisource Health Services LLC

Failed Impurities/Degradation Specification: presence of N-nitroso Prazosin impurity C above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit

OngoingVoluntary: Firm initiated
Class II04/13/2022

Mckesson Medical-Surgical Inc. Corporate Office

cGMP deviations: Temperature abuse

TerminatedVoluntary: Firm initiated
Class II10/07/2025

Teva Pharmaceuticals USA, Inc

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.

OngoingVoluntary: Firm initiated

Frequently Asked Questions

What is PRAZOSIN HYDROCHLORIDE used for?

PRAZOSIN HYDROCHLORIDE contains PRAZOSIN HYDROCHLORIDE. It is a capsule taken oral. Consult your doctor for specific uses.

Is PRAZOSIN HYDROCHLORIDE a controlled substance?

PRAZOSIN HYDROCHLORIDE is not classified as a controlled substance by the DEA.

What is the generic name for PRAZOSIN HYDROCHLORIDE?

The generic name for PRAZOSIN HYDROCHLORIDE is PRAZOSIN HYDROCHLORIDE. There are 12 other brand versions of PRAZOSIN HYDROCHLORIDE.

What is the NDC code for PRAZOSIN HYDROCHLORIDE 2 mg/1?

The NDC (National Drug Code) for PRAZOSIN HYDROCHLORIDE 2 mg/1 is 62332-692, listed by Alembic Pharmaceuticals Inc..