Major Pharmaceuticals Chlorpromazine Hydrochloride 50 mg Tablets Recalled for Nitrosamine Impurity (
Major Pharmaceuticals, via The Harvard Drug Group LLC, recalled 506 blister packs of Chlorpromazine Hydrochloride tablets, 50 mg, distributed nationwide. A CGMP deviation shows the presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit. Stop using the product and contact the Harvard Drug Group or Rugby Laboratories for guidance.
About This Product
Chlorpromazine hydrochloride is a prescription antipsychotic used for certain psychiatric conditions. The recalled lots were packaged as 50 mg tablets in 10x10 blister packs and distributed nationwide.
Why This Is Dangerous
The impurity N-Nitroso Desmethyl Chlorpromazine was found above the recommended intake limit due to CGMP deviations in manufacturing. Prolonged exposure to nitrosamine impurities can pose health risks.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Consumers prescribed this drug should stop using the affected lots and contact their healthcare provider. The recall covers 506 blister packs nationwide and may affect patients who rely on this medication for treatment.
Practical Guidance
How to identify if yours is affected
- Check NDC 0904-7131-61 on the bottle label.
- Verify model numbers N02009 or N02026 on the packaging.
- Look for 50 mg dosage in a (10x10) blister pack.
- Confirm packaging type and UPC if present.
Where to find product info
FDA enforcement page for recall D-0011-2026 and the distributor’s recall notice.
What timeline to expect
Refunds or replacements, if offered, typically take 4-8 weeks.
If the manufacturer is unresponsive
- Document all contact attempts with the distributor.
- File a complaint with the FDA or state consumer protection agency if no response is received.
- Consult your healthcare provider for interim alternatives.
How to prevent similar issues
- When buying prescription medications, verify CGMP compliance and recall status.
- Check NDC codes before use.
- Keep packaging and recall notices until resolved.
Documentation advice
Retain the product packaging, recall notice, and any correspondence with the distributor and your healthcare provider for records.