FDA Recalls Anti-Epileptic Drug
A Class III, nationwide recall of Clonazepam Tablets, USP, 0.5 mg, was announced in the latest US Food and Drug Administration (FDA) Enforcement Report.
The recall affects products in the following packages:
- 100-count unit dose box of 10 x 10 blister cards (NDC code: 51079-881-20)
- 300-count unit dose box of 10 x 30 punch cards (NDC code: 51079-881-56)
More than 1100 unit dose cards of 300 (10 punch cards with 30 tablets each) and nearly 53,000 unit dose blister cards (10 cards with 10 tablets each) were included in the recall, which was voluntarily initiated by Mylan Institutional, Inc. on September 28.
-------
Related Content
U.S. FDA adds new warning about opioid/sedative combination
Two Popular Drugs for Adult Migraines Not as Effective in Adolescents
------
The affected lot numbers are 3061779 (Exp 11/16), 3071447 (Exp 04/17), and 3071789 (Exp 04/17).
So, what prompted this recall? As stated in the FDA report, it was initiated due to failed impurities/degradation specifications.
“Out of specification result for Clonazepam Related Compound (RC) A (a known impurity) at 15 month timepoint,” it wrote.
Use of the recalled product would be unlikely to lead to any adverse health reaction, according to the FDA’s description of a Class III recall.
This recall is ongoing.—Meredith Edwards White
References
https://www.accessdata.fda.gov/scripts/ires/index.cfm
https://www.fda.gov/Safety/Recalls/EnforcementReports/ucm181313.htm
