Sagent recalls NSAID made by Cadila over expiry issue

Sagent Pharmaceuticals' ($SGNT) business model calls for it to rely primarily on contractors to make the sterile injectable drugs that it specializes in. When a contractor has an issue, the effect dominoes to Sagent--a sequence of events that currently resulted in a recall of three lots of a nonsteroidal anti-inflammatory drug (NSAID) manufactured by India's Cadila Healthcare.

According to a recall notice issued by the FDA, the Schaumburg, IL-based company is recalling the lots of ketorolac tromethamine because of a labeling error that gave it an expiration date that is longer than the known stability of the product, the company said. It said the products were sent to wholesalers and distributors in the U.S. Sept.17 through Oct. 1 and there have not been any reports of adverse events.

In March, Sagent voluntarily recalled two lots of zoledronic acid injection, a drug used to treat bone conditions like the rare Paget's disease, after getting a complaint of four leaking bags. It had sourced the drugs from distributor DDN of Dohmen Life Science Services.

Cadila had a another manufacturing issue recently. In July, it acknowledged that it had received a Form 483 after a "product specific" inspection of its Moraiya manufacturing plant, where the company is seeking approval to make an unspecified new product. It explained that the inspection was limited to the review of documents for its ANDA and that it had not received any observations on the standard manufacturing practices at the Moraiya plant.

- here's the Sagent recall