Major ChlorproMAZINE Hydrochloride Tablets, USP, 25 mg, 50 Tablets (5x10) blister package, Rx Only, Packaged and Distributed by Major Pharmaceuticals, Indianapolis, IN 46268, USA, NDC 0904-7130-06, UPC (01)00309047130061
Reported: October 15, 2025 Initiated: September 12, 2025 #D-0009-2026
Product Description
Major ChlorproMAZINE Hydrochloride Tablets, USP, 25 mg, 50 Tablets (5x10) blister package, Rx Only, Packaged and Distributed by Major Pharmaceuticals, Indianapolis, IN 46268, USA, NDC 0904-7130-06, UPC (01)00309047130061
Reason for Recall
CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit
Details
- Units Affected
- 2064 blister packs
- Distribution
- Nationwide
- Location
- La Vergne, TN
Frequently Asked Questions
What product was recalled? ▼
Major ChlorproMAZINE Hydrochloride Tablets, USP, 25 mg, 50 Tablets (5x10) blister package, Rx Only, Packaged and Distributed by Major Pharmaceuticals, Indianapolis, IN 46268, USA, NDC 0904-7130-06, UPC (01)00309047130061. Recalled by The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories. Units affected: 2064 blister packs.
Why was this product recalled? ▼
CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on October 15, 2025. Severity: Moderate. Recall number: D-0009-2026.
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