Sun Pharma controversies
Controversies tied to this brand in public sources. A listing is not a finding of fault.
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2020
DUSA reaches DOJ settlement over drug promotion allegations
Settlement
DUSA Pharmaceuticals, a wholly owned subsidiary of Sun Pharmaceutical Industries, reached a civil settlement with the U.S. Department of Justice and agreed to pay $20.75 million to resolve allegations related to the promotion of LEVULAN KERASTICK and BLU-U. The settlement does not constitute an admission of liability or wrongdoing.
Source excerpt
Under the civil settlement agreements signed with the DOJ, DUSA will pay US$20.75 million to resolve allegations related to the promotion of LEVULAN KERASTICK and BLU-U .
DUSA Pharmaceuticals Inc., a wholly owned subsidiary of Sun Pharmaceutical Industries Inc. announced that it has reached a resolution with the United States Department of Justice (DOJ) concerning the promotion of LEVULAN KERASTICK (aminolevulinic acid HCL) and BLU-U.
The settlement does not constitute any admission by DUSA of any liability or wrongdoing.
2020
Sun Pharma recalls a lot of Riomet ER
Recall announced
Sun Pharmaceutical Industries Inc stated that it was voluntarily recalling one lot of Riomet ER oral suspension in the United States because NDMA levels exceeded the allowable acceptable daily intake limit. The company said it had received no reports of adverse events related to the recall. The recall was described as voluntary and limited to a single lot of the oral suspension product.
Sun Pharmaceutical Industries Inc said it was voluntarily recalling one lot of Riomet ER oral suspension in the US because NDMA levels exceeded the allowable acceptable daily intake limit. The company said it had received no reports of adverse events related to the recall.
Company response
Recall — Sun Pharmaceutical Industries Inc
Sun Pharmaceutical Industries Inc, a wholly-owned subsidiary of Sun Pharmaceutical Industries, is voluntarily recalling one lot of Riomet ER (metformin hydrochloride for extended-release oral suspension) 500 mg per 5 mL to the consumer level
Source excerpt
The US arm of domestic pharma major Sun Pharma has said it is voluntarily recalling one lot of Riomet ER oral suspension in the US market, due to the presence of a probable human carcinogen above the acceptable daily intake limit.
"The reason for the recall is due to the level of N-Nitrosodimethylamine (NDMA), which has been found to be above the allowable acceptable daily intake (ADI) limit established by the USFDA," it added.
To date, the company has not received any reports of adverse events related to this recall, it added.
2020
Sun Pharma recalls RIOMET ER bottles in the US over NDMA impurity
Recall announced
Sun Pharmaceutical Industries, through its US-based subsidiary, recalled 747 bottles of RIOMET ER in the US after NDMA impurity was detected in the finished drug product. The US regulator classified it as a Class II recall.
Company response
Recall — Sun Pharmaceutical Industries
The company initiated the recall on September 23, the USFDA said.
Source excerpt
The company initiated the recall on September 23, the USFDA said.
As per the USFDA, the company is recalling the product due to deviation from the current good manufacturing practices (CGMP) -- detection of N-nitrosodimethylamine (NDMA) impurity in finished drug product.
Leading drug maker Sun Pharma is recalling 747 bottles of generic diabetes drug in the US due to possibility of the affected lot containing cancer causing nitrosodimethylamine (NDMA) above the acceptable intake limit, the US health regulator has said.