Failed Dissolution Test on Drugs The Food and Drug Administration (FDA) of the Philippines, in two separate advisories, has recalled specific lots and batches of two drug products: a cholesterol-lowering drug, and a drug used in the treatment of tuberculosis and other infections..
In its advisories, the Philippine regulatory agency identified the recalled products as Simvastatin 20 mg tablet sold under the brand names Novovast, Squastatin and Qvast, the Manila Bulletin reports. The affected Novovast products are under lot number 13P378B manufactured by Square Pharmaceuticals in Parañaque, Philippines.
The agency said this product lot is being recalled from the market “due to the result of FDA laboratory analysis that the particular lot failed the dissolution test conducted.” Dissolution rate is important to the proper release of a drug’s ingredients.
The FDA explained that Novovast is used to decrease total LDL-cholesterol, apolipoprotein B, and triglycerides and to increase HDL-cholesterol in the treatment of hyperlipidaemias, including hypercholesterolaemias and combined hyperlipidaemia (type IIa or type IIb hyperlipoproteinaemias).
The FDA said that identical drug products Squastatin
In addition, the FDA said that identical drug products Squastatin, Qvast and a generic brand with the same indication and manufacturer are also being recalled, according to the Manila Bulletin.
“The affected product lot presents safety risks and may cause therapeutic failure,” said the FDA, adding that all distributors, hospitals, retailers or pharmacies that have the affected lot are ordered to discontinue further distribution, sale, and use.
In a separate advisory, the Philippine FDA announced the recall of Rifampicin 200 mg/5mLsuspension under the brand name Rifanid. The recalled products, manufactured by Concept Pharmaceuticals in India, are under batches C30002 with an expiration date of May 2016, and C30007 and C30008 with an expiration date of July 2016.
Based on its lab analysis, the agency “found that the impacted product batches did not conform to the specifications on the appearance of the product which should be ‘suspension should settle slowly and should readily re-disperse upon gentle shaking.’
” The agency observed caking in the affected batches that made the suspension not readily re-dispersible and also prevented the suspension from being easily poured from the container.
Several batches of the drug “present safety risks if the suspension is not homogenized before administration to the patient. Some parts will have low potency and other parts will have higher doses of the active ingredient.
Erratic potency of doses unknowingly taken by the patient may possibly cause either therapeutic failure or toxicity,” the Philippine FDA explained.