A nationwide voluntary recall of the seizure medication divalproex sodium delayed-release tablets has been issued by the manufacturer Unichem Pharmaceuticals. The recall was issued earlier this month as a precautionary measure due to the possibility the product may be contaminated with traces of metronidazole. Metronidazole is an antibiotic used to treat a range of bacterial and parasitic infections, including stomach ulcers.
Divalproex sodium, which also goes by the brand names Depakote and Depakote-ER, is used to treat several different seizure disorders, as well as bipolar disorder and migraines. It should not be used by anyone with an allergy to the drug, with liver disease, a urea cycle disorders, or a genetic mitochondrial disorder.
About the Recall:
The recall affects 96,876 bottles distributed throughout the United States. The recall was announced after traces of metronidazole powder were found in one of the bottles, according to a report from the US Food and Drug Administration (FDA) on January 28th, 2018.
It is a Class II recall, the most common type of recall, which the FDA categorizes as 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 health consequences is remote".
Unichem has taken steps to notify its distributors and customers and is arranging the return of all affected products. To date, no reports of adverse events have been received by Unichem.
Affected Products:
Divalproex Sodium DR tablets 500mg, 100's pack
Lot number: ZDPH17040 (Expires 04/30/20)
National Drug Code Number: 29300-140-01
Distribution Date: June - July 2017
Despite the recall, it is important that patients avoid stopping taking their prescription medication without consulting first with their healthcare provider. If you experience any symptoms or problems that may be related to taking contaminated medication, contact a physician or medical professional immediately. Any adverse events associated with medication should be reported to the FDA MedWatch Adverse Event Reporting.
