Home / Recalls / The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories / D-0366-2025

D-0366-2025 Class II Ongoing

Recalled by The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories — La Vergne, TN

Recall Details

Product Type
Drugs
Report Date
April 23, 2025
Initiation Date
April 14, 2025
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
133 cartons

Product Description

ChlorproMAZINE Hydrochloride Tablets, USP, 10 mg, packaged in cartons of 100 TABLETS (10x10), Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268, NDC 0904-7129-61

Reason for Recall

CGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim limit

Distribution Pattern

Nationwide USA

Code Information

Lot#: N02114, Exp 12/31/2025

Other recalls by The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories

  • D-0012-2026 Class II — Major ChlorproMAZINE Hydrochloride Tablets, USP, 100 mg, 100 Tablets (10x10) bli (September 12, 2025)
  • D-0009-2026 Class II — Major ChlorproMAZINE Hydrochloride Tablets, USP, 25 mg, 50 Tablets (5x10) bliste (September 12, 2025)
  • D-0013-2026 Class II — Major ChlorproMAZINE Hydrochloride Tablets, USP, 200 mg, 100 Tablets (10x10) bli (September 12, 2025)
  • D-0010-2026 Class II — Major ChlorproMAZINE Hydrochloride Tablets, USP, 25 mg, 100 Tablets (10x10) blis (September 12, 2025)
  • D-0011-2026 Class II — Major ChlorproMAZINE Hydrochloride Tablets, USP, 50 mg, 100 Tablets, (10x10) bli (September 12, 2025)
  • D-0624-2025 Class II — Sulfamethoxazole and Trimethoprim, USP, 800 mg/160 mg, Double Strength, 100 Tabl (September 2, 2025)
  • D-0625-2025 Class II — Sulfamethoxazole and Trimethoprim, USP, 800 mg/160 mg, Double Strength, 10 Table (September 2, 2025)
  • D-0594-2025 Class II — Carvedilol Tablets USP, 12.5 mg, 100- Tablets, (10x10) cartons, Rx Only, Package (August 20, 2025)
  • D-0304-2025 Class III — Tolterodine Tartrate Extended-Release Capsules, 2 mg, 30 Capsules (3 x 10) Unit (March 4, 2025)
  • D-0221-2025 Class II — Potassium Chloride Extended-Release Tablets, USP, 10 mEq (750 mg), 100 Tablets p (January 30, 2025)