Recalls / Class III
Class IIID-0111-2018
Product
Methylphenidate Hydrochloride Extended-release Tablets, USP 54 mg, 100-count bottles, Rx Only, Trigen Laboratories, LLC. Bridgewater, NJ 08807, NDC 13811-709-10
- 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
- Lot #: 170029A, Exp. 02/2019; 170030A, Exp. 02/2019
Why it was recalled
Subpotent Drug
Recalling firm
- Firm
- Osmotica Pharmaceutical Corp
- Manufacturer
- Trigen Laboratories, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 895 Sawyer Rd, Marietta, Georgia 30062-2257
Distribution
- Quantity
- 9919 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2017-12-18
- FDA classified
- 2017-12-20
- Posted by FDA
- 2017-12-27
- Terminated
- 2019-05-01
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0111-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.