Key Points

Three major Indian pharmaceutical companies—Sun Pharma, Lupin, and Dr Reddy's—are recalling medicines in the US due to quality issues. Sun Pharma's ADHD drug failed dissolution tests, while Lupin's blood pressure medication was found mixed with HIV tablets. Dr Reddy's stomach capsules were contaminated with unrelated tablets. The USFDA has classified all recalls as Class II, indicating temporary but not life-threatening risks.

Key Points: Sun Pharma Lupin Dr Reddy's Recall US Drugs Over Quality Issues

  • Sun Pharma recalls ADHD drug over dissolution failure
  • Lupin pulls blood pressure meds after HIV pills found in bottles
  • Dr Reddy's withdraws stomach capsules due to foreign tablets
  • USFDA classifies all three recalls as Class II health risks
2 min read

Sun Pharma, Lupin, Dr Reddy's recall medicines in US over quality issues

Indian pharma giants Sun Pharma, Lupin, and Dr Reddy's recall ADHD, blood pressure, and stomach medicines in US due to failed tests and product mix-ups.

"Product Mix Up – USFDA on Lupin's blood pressure drug containing HIV tablets"

Mumbai, July 27

Indian pharmaceutical companies Sun Pharma, Lupin, and Dr Reddy's Laboratories are recalling some of their medicines from the US market due to manufacturing problems and product mix-ups, as per the US Food and Drug Administration (USFDA) latest enforcement report.

Sun Pharmaceutical Industries, headquartered in Mumbai, is recalling 5,448 bottles of a generic drug used to treat Attention Deficit Hyperactivity Disorder (ADHD).

The medicine in question is Lisdexamfetamine Dimesylate capsules, which failed to meet the required dissolution standards during testing.

The recall was initiated by Sun's US arm, Princeton-based Sun Pharmaceutical Industries Inc., on June 16. The USFDA has classified this as a Class II recall.

Lupin, another leading drug maker based in Mumbai, is recalling 58,968 bottles of a generic medicine used to treat high blood pressure.

The medicine, a combination of Lisinopril and Hydrochlorothiazide tablets, was manufactured at Lupin’s Nagpur facility and recalled by its US unit, Lupin Pharmaceuticals Inc, based in Naples.

The recall began on June 20, following a complaint that a sealed bottle of the blood pressure drug contained a different medicine -- a tablet of Atazanavir and Ritonavir, used for HIV treatment.

The USFDA termed this a case of "Product Mix Up" and also classified it under Class II recall.

In a similar case, Dr Reddy's Laboratories is recalling 1,476 bottles of Omeprazole delayed-release capsules, which are commonly used to treat stomach and oesophagus problems.

According to the USFDA, the recall was initiated by Dr Reddy’s US unit based in Princeton on June 30. The affected lot was manufactured at the company’s Bachupally plant in India.

The reason for the recall was the presence of foreign tablets -- specifically, Divalproex Sodium extended-release tablets -- found in bottles that were supposed to contain only Omeprazole capsules.

According to the USFDA, a Class II recall is issued when the use of a defective product may cause temporary or medically reversible health problems, but the chances of serious health issues are low.

- IANS

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Reader Comments

P
Priya S
Product mix-ups in medicines can be dangerous! FDA is right to be strict. Indian companies should maintain same quality standards globally as they do for domestic market.
A
Aman W
At least they're recalling voluntarily. Shows responsibility. But why do such mistakes happen in first place? Need better quality control at manufacturing plants.
S
Sarah B
As someone who takes one of these medicines, this is scary! 😨 Hope the companies compensate affected patients and improve their processes.
K
Karthik V
USFDA standards are toughest in world. Our companies should see this as opportunity to upgrade systems rather than just damage control. Make in India should mean Quality in India!
N
Nisha Z
These are big names in pharma - Sun Pharma, Dr Reddy's, Lupin. If they're making such mistakes, what about smaller companies? CDSCO should conduct surprise audits!
D
David E
The HIV medicine mix-up in blood pressure drugs is particularly alarming. Patients could face serious drug interactions. Need better packaging and verification systems.

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