Dr Reddy's, Lupin recall products in US due to manufacturing issues: USFDA
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 Suspen