February 2018 FDA Recall Methylphenidate Hydrochloride by Osmotica Pharmaceutical Corp
D-0581-2018 - Subpotent Drug
This Class III drug recall was voluntarily initiated by Osmotica Pharmaceutical Corp on February 28, 2018 for the product Methylphenidate Hydrochloride. The FDA reported the reason for recall as subpotent drug. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-0581-2018
Subpotent Drug:100-count product bottle labeled as Methylphenidate HCL ER Tablets 36 mg found to contain 1 27 mg Methylphenidate HCL ER Tablet.
02-28-2018
03-14-2018
19,664 100-bottles
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Osmotica Pharmaceutical Corp
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide in the USA
05-01-2019
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Methylphenidate Hydrochloride Extended-release Tablets, USP, 36 mg, 100-count bottle, Rx only, Trigen Laboratories, LLC Bridgewater, NJ 08807. NDC 13811-708-10
Batch or Lot Expiration Information
Lot# Lots: 170231B, 170232A, 170233A, 170234A
