Recall_2016-196: Supernus Pharma – TROKENDI XR 200MG BP 30 –Consumer
URGENT!!! DRUG RECALL!!! URGENT!!!Description Lot # Exp Date NDC
TROKENDI XR 200MG BP 30 476916 06/11/2019 17772010415
Supernus Pharma, is voluntarily recalling the above item(s)/lot(s) due to the lot has improperly placed tamper evident seals that do not meet specification for child-resistance as required by the Poison Prevision Packaging Act, posing a risk of poisoning if swallowed by children. There is no issue with the internal blister card or drug product. This product is safe for use when used as directed. This recall is to the Consumer level. Affected product started shipping 11/9/16.
This recall is being conducted with the knowledge of the FDA.
Information contained in this document was provided by Supernus Pharma.
Stericycle, Inc.: Consumer Support 888-641-9736