Appco Pharma Prazosin 2mg Capsules Recall - Nitrosamine Impurity

Appco Pharma LLC

Drug Recalls (Class II)

← All Drug Recalls (Class II) Class II D-0420-2026 · 20260408 · Ongoing · Voluntary: Firm initiated

Product

Prazosin Hydrochloride Capsules, USP, 2mg, 100-count bottle, Rx Only, Manufactured for: Biocon Pharma Inc., Iselin, NJ, Manufactured by: Appco Pharma LLC, Piscataway, NJ, NDC 70377-067-11.

Reason for Recall

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

Affected Lot Numbers / Codes

Lot:2404153UC, Exp.: 2026/MAR; 2404154UC, Exp.:2026/MAR; 2502055UC, Exp.: 2027/JAN; 2505173UC, Exp.: 2027/MAY; 2505175UC, Exp.: 2027/MAY.

Quantity

58,896 bottles- 100's count

Firm Notification Method

E-Mail

Distribution

U.S.A. Nationwide

Initiated

20260327

FDA Classified

20260331

Product Registration

Brand: PRAZOSIN HYDROCHLORIDE

Manufacturer: Biocon Pharma Inc.

Application: ANDA213406

NDC: 70377-066, 70377-067, 70377-068

Drug Label Context (from openFDA)

The following is from the manufacturer's FDA-approved drug label, not recall-specific. Provided for context.

Indications & Usage

INDICATIONS AND USAGE Prazosin hydrochloride capsules is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes, including this drug. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cess...

Dosage & Administration

DOSAGE AND ADMINISTRATION The dose of Prazosin hydrochloride capsules should be adjusted according to the patient's individual blood pressure response. The following is a guide to its administration: Initial Dose 1 mg two or three times a day (see WARNINGS.) Maintenance Dose Dosage may be slowly increased to a total daily dose of 20 mg given in divided doses. The therapeutic dosages most commonly employed have ranged from 6 mg to 15 mg daily given in divided doses. Doses higher than 20 mg usually do not increase efficacy, however a few patients may benefit from further increases up to a dai...

Contraindications

CONTRAINDICATIONS Prazosin hydrochloride capsules are contraindicated in patients with known sensitivity to quinazolines, prazosin, or any of the inert ingredients.

Warnings

WARNINGS As with all alpha-blockers, Prazosin hydrochloride capsules may cause syncope with sudden loss of consciousness. In most cases, this is believed to be due to an excessive postural hypotensive effect, although occasionally the syncopal episode has been preceded by a bout of severe tachycardia with heart rates of 120 to 160 beats per minute. Syncopal episodes have usually occurred within 30 to 90 minutes of the initial dose of the drug; occasionally, they have been reported in associat...

Adverse Reactions

ADVERSE REACTIONS Clinical trials were conducted on more than 900 patients. During these trials and subsequent marketing experience, the most frequent reactions associated with Prazosin hydrochloride capsules therapy are: dizziness 10.3%, headache 7.8%, drowsiness 7.6%, lack of energy 6.9%, weakness 6.5%, palpitations 5.3%, and nausea 4.9%. In most instances, side effects have disappeared with continued therapy or have been tolerated with no decrease in dose of drug. Less frequent adverse rea...

Drug Interactions

Drug Interactions Prazosin hydrochloride capsules has been administered without any adverse drug interaction in limited clinical experience to date with the following: (1) cardiac glycosides–digitalis and digoxin; (2) hypoglycemics–insulin, chlorpropamide, phenformin, tolazamide, and tolbutamide; (3) tranquilizers and sedatives– chlordiazepoxide, diazepam, and phenobarbital; (4) antigout–allopurinol, colchicine, and probenecid; (5) antiarrhythmics–procainamide, propranolol (see WARNINGS howev...

How Supplied

HOW SUPPLIED Prazosin Hydrochloride Capsules, USP are available containing prazosin hydrochloride, USP equivalent to 1 mg, 2 mg, or 5 mg of prazosin. The 1 mg capsule is a hard gelatin capsule with white opaque body and white opaque cap imprinted with “AC” on cap and ‘540’ on body in black ink filled with white to off white powder. They are available as follows: bottles of 100 capsules (NDC 703...

Sources: openFDA · Raw JSON