Dr Reddy's, Lupin Recall Products in US Due to Manufacturing Issues
By Rediff Money Desk, New Delhi Sep 04, 2024 16:02
Dr Reddy's Laboratories and Lupin are recalling products in the US due to manufacturing issues, including Ibuprofen tablets and Cefixime for Oral Suspension.
![Dr Reddy's, Lupin Recall Products in US Due to Manufacturing Issues](https://im.rediff.com/money/2020/aug/19drug.jpg)
New Delhi, Sep 4 (PTI) Dr Reddy's Laboratories and Lupin are recalling products in the US due to manufacturing issues, as per the US Food and Drug Administration (USFDA).
Dr Reddy's Laboratories Inc, a subsidiary of Hyderabad-based drug firm, is recalling Ibuprofen tablets in multiple strengths, the US health regulator said in its latest enforcement report.
Ibuprofen tablets are indicated for pain relief and fever.
New Jersey-based Dr Reddy's Laboratories Inc. is recalling 1,03,298 bottles (800 mg); 31,802 bottles (600 mg); and 14,940 bottles (400 mg) of Ibuprofen tablets in the US market, USFDA said.
The company is recalling the affected lot due to "Failed impurities/degradation specifications," it added.
"Results for unknown impurity were 0.13 per cent and 0.11 per cent, respectively, exceeding the 0.10 per cent specification limit," USFDA noted.
The company initiated the Class II nationwide recall on August 6 this year.
USFDA stated that Lupin is recalling 4,554 bottles of Cefixime for Oral Suspension in the market.
The US-based arm of the Mumbai-based drug maker is recalling the affected lot of the drug, used to treat bacterial infections, on account of it being "Subpotent".
Baltimore-based Lupin Pharmaceuticals Inc. initiated the Class II recall on August 21.
As per the USFDA, a Class II recall is initiated in a situation in which the use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Dr Reddy's Laboratories Inc, a subsidiary of Hyderabad-based drug firm, is recalling Ibuprofen tablets in multiple strengths, the US health regulator said in its latest enforcement report.
Ibuprofen tablets are indicated for pain relief and fever.
New Jersey-based Dr Reddy's Laboratories Inc. is recalling 1,03,298 bottles (800 mg); 31,802 bottles (600 mg); and 14,940 bottles (400 mg) of Ibuprofen tablets in the US market, USFDA said.
The company is recalling the affected lot due to "Failed impurities/degradation specifications," it added.
"Results for unknown impurity were 0.13 per cent and 0.11 per cent, respectively, exceeding the 0.10 per cent specification limit," USFDA noted.
The company initiated the Class II nationwide recall on August 6 this year.
USFDA stated that Lupin is recalling 4,554 bottles of Cefixime for Oral Suspension in the market.
The US-based arm of the Mumbai-based drug maker is recalling the affected lot of the drug, used to treat bacterial infections, on account of it being "Subpotent".
Baltimore-based Lupin Pharmaceuticals Inc. initiated the Class II recall on August 21.
As per the USFDA, a Class II recall is initiated in a situation in which the use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Source: PTI
DISCLAIMER - This article is from a syndicated feed. The original source is responsible for accuracy, views & content ownership. Views expressed may not reflect those of rediff.com India Limited.
You May Like To Read
TODAY'S MOST TRADED COMPANIES
- Company Name
- Price
- Volume
- GTL Infrastructure
- 2.59 ( -1.15)
- 48988527
- Axita Cotton
- 22.67 ( -5.74)
- 29420018
- Vodafone Idea L
- 14.83 ( -1.85)
- 29110630
- Rajnish Wellness
- 3.84 ( -4.95)
- 28481388
- Rama Steel Tubes
- 11.59 (+ 10.17)
- 18767890
MORE NEWS
![Canara Bank...](https://im.rediff.com/80-80/money/2016/mar/28bank.jpg)
Canara Bank Raises USD 300 Million via IFSC Unit
Canara Bank successfully raises USD 300 million through its International Financial...
![India Beauty &...](https://im.rediff.com/80-80/money/2017/jul/03nykaa4.jpg)
India Beauty & Personal Care Market to Reach...
India's beauty and personal care market is projected to reach $34 billion by 2028,...
Sebi Denies Toxic Work Culture Claims, Calls...
Sebi has refuted claims of a toxic work environment, stating that they are misplaced...