Dr. Reddy’s Issues U.S. Recall of Epilepsy, Hypertension Drugs

Dr. Reddy’s Laboratories is recalling drugs used to treat seizures and high blood pressure from the U.S. market due to dissolution and potency issues. All of the affected products were manufactured at DRL’s Bachupally, Hyderabad, India, facility, FDA enforcement reports show.

Four lots of the epilepsy drug divalproex sodium extended-release tablets were recalled because they exceeded dissolution at the nine-hour time point. The voluntary recall, initiated May 22, affects 7,479 100-count bottles and 2,544 500-count bottles of the 250 mg version, along with one lot of the 100-count 500 mg version of the drug.

On May 6, DRL launched a recall of the hypertension drug amlodipine besylate and atorvastatin calcium tablets in the following strengths due to subpotency. Affected were one lot of 5mg/40mg packaged in 30-count and 90-count bottles, two lots of 5mg/10mg packaged in 30- and 90-count bottles, one lot of 10mg/40mg in 90-count bottles and two lots of 10mg/10mg in 30- and 90-count bottles. The lots all have an expiry date of July 2015.

DRL’s Princeton, N.J., U.S. headquarters sent letters to customers alerting them of the recall. — Kellen Owings