Recalls / Class III
Class IIID-0581-2018
Product
Methylphenidate Hydrochloride Extended-release Tablets, USP, 36 mg, 100-count bottle, Rx only, Trigen Laboratories, LLC Bridgewater, NJ 08807. NDC 13811-708-10
- Brand name
- Methylphenidate Hydrochloride
- Generic name
- Methylphenidate Hydrochloride
- Active ingredient
- Methylphenidate Hydrochloride
- Route
- Oral
- NDCs
- 13811-706, 13811-709, 13811-707, 13811-708, 13811-710
- FDA application
- ANDA205327
- Affected lot / code info
- Lots: 170231B, 170232A, 170233A, 170234A
Why it was recalled
Subpotent Drug:100-count product bottle labeled as Methylphenidate HCL ER Tablets 36 mg found to contain 1 27 mg Methylphenidate HCL ER Tablet.
Recalling firm
- Firm
- Osmotica Pharmaceutical Corp
- Manufacturer
- Trigen Laboratories, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 895 Sawyer Rd, N/A, Marietta, Georgia 30062-2257
Distribution
- Quantity
- 19,664 100-bottles
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2018-02-28
- FDA classified
- 2018-03-06
- Posted by FDA
- 2018-03-14
- Terminated
- 2019-05-01
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0581-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.