Home health remedies Dr. Reddy’s extends infusion recall even as its expands retrieval of potentially...

Dr. Reddy’s extends infusion recall even as its expands retrieval of potentially dangerous infants’ ibuprofen

93
0
SHARE

Dr. Reddy’s Laboratories, whose manufacturing has come under repeated FDA criticism, has in the last week had to expand or reiterate the recalls of two products, including potentially harmful infants’ ibuprofen.

The Indian drugmaker, which last fall began a recall to the consumer level of three lots of Infants’ Ibuprofen Concentrated Oral Suspension, USP 50 mg per 1.25 mL, has now added three more lots to the effort. The products were sold in Walmart, CVS and Family Dollar stores

The product was produced by its Tris Pharma unit, whose plant in Monmouth Junction, New Jersey, was slapped last year with an FDA warning letter for its lack of urgency about investigating product failures.

Free Daily Newsletter

Like this story? Subscribe to FiercePharma!

Biopharma is a fast-growing world where big ideas come along daily. Our subscribers rely on FiercePharma as their must-read source for the latest news, analysis and data on drugs and the companies that make them. Sign up today to get pharma news and updates delivered to your inbox and read on the go.

RELATED: Tris Pharma, a CMO for Pfizer, hit with FDA warning letter for ADHD drug, morphine solution

The drugmaker has said there is a remote possibility that infants “susceptible to a higher potency level of drug” could end up with permanent kidney damage from the nonsteroidal anti-inflammatory drug. Tris has not received any reports of adverse events, but reactions can include nausea, vomiting and stomach pain.

This recall came days before Dr. Reddy’s renewed a call for the return of infusion bags of levetiracetam in 0.54% Sodium Chloride Injection, 1,500 mg/100 mL (15 mg/mL). That recall of single-dose infusion bags is to the hospital level in the U.S.

RELATED: Repeat violations stack up at Dr. Reddy’s cancer drug plant 

That recall of the infused drug was first initiated in October because of mislabeling issues. The pre-printed text primary container indicates product information for one dose form of levetiracetam while the label on the external foil pouch has information for another dose form. While there have been no reports of adverse events related to this recall, Dr. Reddy’s has said that patients that receive the solution could experience effects including somnolence, agitation, aggression or even go into a coma related to over-dosage.

Dr. Reddy’s received a scathing FDA warning letter in 2015 for three manufacturing plants in India, including an oncology drug plant that has since seen further citations. Nearly a year ago, the FDA criticized the Tris manufacturing facility in New Jersey for the company’s inadequate investigation of defect complaints and product failures. The agency said Tris “lacked thorough investigations into root causes, and failed to implement prompt and effective corrective actions and preventative actions.”

Source link

LEAVE A REPLY

Please enter your comment!
Please enter your name here

sixteen + three =