Last Updated on September 2, 2025 by The Health Master
Drug recall
In a world where pharmacology keeps us ticking, it’s interesting to note a drug recall that’s voluntary.
Recently, Alembic Pharmaceuticals was noted by the US division voluntarily recalling the antidepressant drug, Doxepin, for “CGMP Deviations.” But what does this all mean for me? Here’s what you need to know.
Why this drug recall—Doxepin?
Ultimately it comes down to quality control. Per a recent update by the USFDA, Alembic Pharmaceuticals is voluntarily recalling 9,492 bottles of Doxepin Hydrochloride Capsules due to an unexpected finding from a routine inspection.
A certain type of impurity was found in the medication that’s called a Nitrosamine Drug Substance Related Impurity (NDSRI).
Why is this important? Because the amount of this impurity was above the limit of acceptable safety.
Essentially, think of this as a very, very small additive that, per the USFDA recommendations, should not be in the medication, and thus, for good measure, the company chose this drug recall.
What is a Class II Drug Recall?
A Class II drug recall is a USFDA classification for products that could cause temporary or medically reversible health problems.
It indicates that the potential for serious health issues is remote, but the drug is still being removed from the market to prevent any potential harm.
What you should know about Doxepin:
Many of you may recognize that Doxepin is a common medication.
Doxepin is mainly prescribed for depression/anxiety but also for bedwetting and a few other concerned issues.
Because it’s a versatile drug, this drug recall will hit home with many people.
This is a testament to the highly supervised and complicated drug manufacturing process.
CGMP deviations are known as Current Good Manufacturing Practices which are laws and regulations imposed upon pharmaceutical companies to ensure their drugs are safe, effective, and pure.
When deviations occur, it’s critical to raise the flag and see what needs to be done for correction.
Q: What are Nitrosamines and are they dangerous?
A: Nitrosamines are a certain chemical compound; some Nitrosamines are known as probable human carcinogens. This means that over time, long-term exposure can heighten cancer risk. However, in this case, the risk is minuscule, and the drug recall is merely precautionary.
Q: How do impurities end up in medicine?
A: Impurities like Nitrosamines can be formed during the production process or as byproducts of chemical forms created to make the drug. Companies are always evolving their production methods to improve upon this.
Disclaimer: This article contains information obtained from the source mentioned below. Our team made changes in the format to rewrite and present the news or article in a unique format.
Drug recall: Sun Pharma recalls 11,328 bottles of BP drug
NSQ drug recall time reduced – 30 days to 3 days
Drug recall: Sun Pharma, Lupin, Dr. Reddy’s recall drugs
Drug recall: Sun Pharma recalls 5,488 bottles of ADHD drug
Drug recall: Granules recalls 33,000 bottles of BP drug
Drug recall: Dr Reddy’s and Lupin recall drugs due to these reasons
Focus on R&D, secure Patents for New Drugs: PM
Big Push for Safer Medicines: Launches “SHRESTH” to rank States
Drug recall: Sun Pharma recalls 11,328 bottles of BP drug
New Draft Standards for IVD Medical Devices: CDSCO
UCPMP 2024: A New Era for Ethical Pharma Marketing
Final Call: No more extensions for WHO-GMP certification
CDSCO Approval: Panel Nod For Alfuzosin-Tadalafil FDC PMS Study
New Recruitment Rules for Deputy Drugs Controller, CDSCO
