Why it was recalled
Subpotent Drug
Product description
Methylphenidate Hydrochloride Extended-release Tablets, USP 54 mg, 100-count bottles, Rx Only, Trigen Laboratories, LLC. Bridgewater, NJ 08807, NDC 13811-709-10
Lot numbers, UPCs & expiration codes
Lot #: 170029A, Exp. 02/2019; 170030A, Exp. 02/2019
Where it was sold
Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0111-2018
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Dec 18, 2017
- FDA report date
- Dec 27, 2017
- Quantity
- 9919 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Osmotica Pharmaceutical Corp
Original FDA data
Every field from FDA enforcement report D-0111-2018, exactly as published.
Show all FDA fields
- City
- Marietta
- State
- GA
- Status
- Terminated
- Country
- United States
- Event ID
- 78764
- Address
- 895 Sawyer Rd
- Code information
- Lot #: 170029A, Exp. 02/2019; 170030A, Exp. 02/2019
- Postal code
- 30062-2257
- Report date
- Dec 27, 2017
- Product type
- Drugs
- Recall number
- D-0111-2018
- Classification
- Class III
- Recalling firm
- Osmotica Pharmaceutical Corp
- Product quantity
- 9919 bottles
- Termination date
- May 1, 2019
- Reason for recall
- Subpotent Drug
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Methylphenidate Hydrochloride Extended-release Tablets, USP 54 mg, 100-count bottles, Rx Only, Trigen Laboratories, LLC. Bridgewater, NJ 08807, NDC 13811-709-10
- Distribution pattern
- Nationwide
- Recall initiation date
- Dec 18, 2017
- Initial firm notification
- Letter
- Center classification date
- Dec 20, 2017