D-0581-2018 Class III Terminated
FDA drug recall D-0581-2018 was initiated by Osmotica Pharmaceutical Corp on February 28, 2018 and is designated Class III. Reason for recall: Subpotent Drug:100-count product bottle labeled as Methylphenidate HCL ER Tablets 36 mg found to contain 1 27 mg Methylphenidate HCL ER Tablet. The recall status is terminated (terminated May 1, 2019). Affected quantity: 19,664 100-bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- March 14, 2018
- Initiation Date
- February 28, 2018
- Termination Date
- May 1, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 19,664 100-bottles
Product Description
Methylphenidate Hydrochloride Extended-release Tablets, USP, 36 mg, 100-count bottle, Rx only, Trigen Laboratories, LLC Bridgewater, NJ 08807. NDC 13811-708-10
Reason for Recall
Subpotent Drug:100-count product bottle labeled as Methylphenidate HCL ER Tablets 36 mg found to contain 1 27 mg Methylphenidate HCL ER Tablet.
Distribution Pattern
Nationwide in the USA
Code Information
Lots: 170231B, 170232A, 170233A, 170234A