Major depression drug recalled over wrong dosage.
Several pharma makers recalled more lots of Ranitidine due to a carcinogenic impurity, while one pharma maker recalled a drug to treat depression.
Denton Pharma, Inc. dba Northwind Pharmaceuticals voluntarily recalled all unexpired lots of Ranitidine Tablets 150 mg. and 300 mg. to the consumer level, due to the presence or potential presence of N-nitrosodimethylamine (NDMA), the pharma maker said in a press release.
NDMA is classified as a probable human carcinogen, based on results from laboratory tests.
Appco Pharma LLC is also voluntarily recalling all quantities and lots, within expiry, of Ranitidine Hydrochloride Capsules to the consumer level due to potential NDMA.
Appco’s marketing partner, ANI Pharmaceuticals Inc., will be notifying its distributors and customers by phone and in writing to immediately discontinue distribution of the specific lots being recalled and to notify their sub-accounts.
The FDA first warned about NDMA in Ranitidine products, including Zantac, this fall. Since then, many ranitidine products have been recalled.
Meanwhile, Aurobindo Pharma USA is voluntarily recalling a lot of Mirtazapine tablets for major depressive disorder due to a label error on declared strength. Bottles labeled as Mirtazapine 7.5 mg. may actually contain 15 mg. tablets.
“Taking a higher dose than expected may increase risk of sedation, agitation, increased reflexes, tremor, sweating, dilated pupils, gastrointestinal distress, nausea, constipation and more. Unexpected levels of sedation in particular can contribute to falls in the elderly or motor vehicle accidents in adults,” Aurobindo said in a press release.
The affected lot number for both Mirtazapine Tablets 7.5 mg. and Mirtazapine Tablets 15 mg. are 03119002A3, with an expiration date of 03/2022.