Recall of Over 40,000 Bottles of Antidepressant, Venlafaxine Hydrochloride
As reported in Reuters and the FDA’s website, 41,127 bottles of the antidepressant, Venlafaxine Hydrochloride Extended-Release Tablets, 150 mg, are being recalled in the U.S. by India’s Sun Pharmaceutical Industries. In a post on its website, the FDA said, “Stability results found the product did not meet the drug release dissolution specifications.” Dissolution tests help determine how the drug will perform inside the body.
The recall has been classified by the FDA as Class II, meaning that use of or exposure to the drug may cause temporary or medically reversible adverse health consequences.
The drug is distributed by Caraco Pharmaceutical Laboratories, Ltd., 1150 Elijah McCoy Drive, Detroit, MI 48202 and manufactured at Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India.
As pointed out in the Reuter’s article, “[t]he company’s recall of venlafaxine hydrochloride comes three months after Pfizer Inc said it was pulling 104,000 bottles of the same drug, which the U.S. company sells under the brand Effexor XR, after a pharmacist reported that one of the bottles contained a heart drug.”
The law firm of devotes its practice to the field of pharmaceutical and medical device litigation. ZK is dedicated to compelling companies to produce safer products. Injured clients and partnering attorneys from across the U.S. appreciate and rely upon over 50 years of combined experience in pharmaceutical mass torts and multidistrict litigation. ZK’s experienced team includes a practicing physician-attorney and all the technology, knowledge and experience necessary to succeed in this complex legal field. For additional information about this or other drug recalls, contact ZK toll-free at (888)841-9623. Initial consultations are always free and confidential.