In its July 9, 2014 weekly enforcement report, FDA reported three voluntary drug product recalls from three different manufacturers due to dissolution problems.
Caraco Pharmaceutical Laboratories, Ltd., a subsidiary of Sun Pharma, has initiated a recall of more than 40,000 bottles of ventafaxine hydrocholoride extended release tablets, due to failed dissolution specifications. The recalled antidepressant tablets, in 30-count and 90-count bottles, were manufactured at Sun Pharmaceutical’s facility in Gujarat, India. FDA reports that stability results found the product did not meet the drug release dissolution specifications. The Class II recall applies to products distributed in the US and Puerto Rico and was initiated on June 12, 2014.
Forest Pharmaceuticals initiated a recall of 92,544 bottles of Bystolic (nebivolol) tablets due to failed stage III dissolution testing. The recall, classified by FDA as Class II, involved 20 mg tablets in 7-tablet professional sample bottles. Forest Pharmaceuticals issued the recall for recalled products distributed in the US and Puerto Rico on June 19.
West-Ward Pharmaceuticals has recalled more than 26,000 bottles of isoniazid tablets in 30-, 100-, and 1000-count bottles. The tuberculosis drug, manufactured by West-Ward for VersaPharm, failed dissolution specifications. FDA reports that stability lots cannot support dissolution past the 36-month time point. The Class II recall was initiated on May 20.
A Class II recall, as defined by FDA, is a situation 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.