Drug Recall Warnings: PharmaTech, Zydus Pharma

The FDA has announced two drug recall warnings: PharmaTech, Zydus Pharma. One is a voluntary recall for Diocto Liquid and Diocto Syrup manufactured by PharmaTech of Davie, Florida. The other, also a voluntary recall, for Divalproex Sodium produced by the India based firm Zydus.

The drug recall warnings of the PharmaTech products is due to a risk of possible bacterial contamination with Burkholderia cepacia. If a product contains B. cepacia, its use could result in infections in patients with compromised immune systems and in patients with chronic lung conditions such as cystic fibrosis. Some of these infections may be serious or even life-threatening in the at-risk patient population. The FDA warned the company about possible contamination after receiving several incident reports of infection possibly linked to the product. Diocto Liquid and Diocto Syrup are used as stool softeners and are packaged in one pint (473 mL) bottles. All lots with NDC 0536-0590-85 and NDC 0536-1001-85 are included in this recall. The products are distributed by Leader Brand, Major Pharmaceuticals and Rugby Laboratories.

The recall of the Zydus product is due to failed dissolution specifications. It is a Class II recall in which “in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote,” according to the FDA. Divalproex Sodium delayed release tablets are used for treatment of seizures and manic episodes in people with bipolar disorder.

For more information about FDA recall warnings, please view our page on FDA recalls and the FDA website. For more information about Drug Recall Warnings: PharmaTech, Zydus Pharma, please see the FDA website.