Multi-event December 2017 FDA Recall Methylphenidate Hydrochloride by Osmotica Pharmaceutical Corp
This Multi-event Class III drug recall was voluntarily initiated by Osmotica Pharmaceutical Corp on December 18, 2017 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.
Reported Recall Events
Recall Number: D-0110-2018
Subpotent Drug
12-18-2017
12-27-2017
10064 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
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 27 mg, 100-count bottles, Rx Only, Trigen Laboratories, LLC. Bridgewater, NJ 08807, NDC 13811-707-10
Batch or Lot Expiration Information
Lot# : 170027A, Exp. 02/2019
Recall Number: D-0111-2018
Subpotent Drug
12-18-2017
12-27-2017
9919 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
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 54 mg, 100-count bottles, Rx Only, Trigen Laboratories, LLC. Bridgewater, NJ 08807, NDC 13811-709-10
Batch or Lot Expiration Information
Lot# : 170029A, Exp. 02/2019; 170030A, Exp. 02/2019
