Sun's Halol unit hit by second recall this year

Sun Pharma Global Fze, a unit of Sun Pharmaceutical Industries, has initiated recall of 5,322 bottles of eye drop Ketorolac Tromethamine ophthalmic solution in the US and Puerto Rico after it failed to meet specification limit.

The drug is manufactured at Sun Pharma's Halol facility in Gujarat, which had received a Form 483 from the US Food and Drug Administration (US FDA) in September 2014. The company had also recalled a number of other drugs from the said facility in the recent past.

In a notification by US FDA on its website, it said Sun Pharma Global Fze has initiated voluntary recall of Ketorolac Tromethamine Ophthalmic Solution, 0.5%, 3 ml bottle on January 21, 2015. The prescription-only drug was manufactured at Halol and was distributed by Sun's US-based subsidiary Caraco Pharmaceutical Laboratories. Sun Pharma Global Fze is the UAE subsidiary of the city-headquartered Sun Pharma.

Ketorolac tromethamine eye drops are used for allergic conjunctivitis (pink eye) and for the treatment of post-operative inflammation, pain, burning, and stinging after eye procedures such as cataract surgery and corneal refractory surgery.

US FDA notified it was a Class II recall and the reason was due to the presence of particulate matter as the product lot was not meeting the specification limit for number of particles present in the solution. The expiry date of the batch is July 2015.

A Class II recall means use/exposure to the drug may cause temporary or medically reversible adverse health consequences, according to the US drug regulator.

The Halol unit, which contributes for an estimated 20-25% of Sun's sales, was issued a Form 483 last year due to some procedural observations raised by the US drug regulator. There were about 23 observations for the injectable unit, four for the oral solid unit and the rest for the quality control lab, according to an earlier report by an international stock brokerage.

A Form 483 is issued by FDA to a company's management at the conclusion of an inspection done on a company's facility when an investigator(s) has observed any conditions that in their judgement may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.

To an email query by dna, Sun Pharma's official spokesperson, said, "The remediation efforts are on at Halol unit and we are fully committed to fulfilling our commitments made in our response to US FDA on the 483. Apart from stating that there is no significant material impact of this recall, we have no other specific comment to offer."

Last month, Sun also issued recall of epilepsy drug Levetiracetam after it failed dissolution specification. The drug was manufactured at the company's Halol facility. Since May 2014, there were at least over four voluntary recalls from the said facility.

However, recently Sun Pharma Advanced Research Company (SPARC), a subsidiary of the pharma major, received approval for its new drug application (NDA) for Elepsia XR (Levetiracetam extended-release tablets 1000 mg and 1500 mg) which will be manufactured at the Halol unit of the company. According to analysts, this the first approval the facility received post issuance of the Form 483 in September last year.

In a separate development, Par Pharmaceutical Inc has also initiated a voluntary recall of 2,856 cartons (each containing 5 packets) of antimicrobial agent Mafenide Acetate, USP, for 5% Topical Solution, 50 grams sterile powder per packet in the US.

The prescription-only drug with PAR Pharmaceuticals label was manufactured in India and was distributed by Par Pharmaceutical Companies, Inc, Spring Valley, New York. The reason for reason is given by FDA as presence of foreign substance such as oxidised steel, organic material and shredded polypropylene.

The drug is indicated for use as an adjunctive topical antimicrobial agent to control bacterial infection when used under moist dressings over meshed autografts on excised burn wounds.