Why it was recalled
CGMP deviations: Product bottle may be absent of desiccant.
Product description
Methylphenidate hydrochloride Extended-Release ablets USP (CII), 18 mg, 100-count bottle, Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 62037-725-01
Lot numbers, UPCs & expiration codes
Lot #: 1332796 A, Exp 11/2020
Where it was sold
USA 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-0836-2020
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jan 27, 2020
- FDA report date
- Feb 19, 2020
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Teva Pharmaceuticals USA
Original FDA data
Every field from FDA enforcement report D-0836-2020, exactly as published.
Show all FDA fields
- City
- Parsippany
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 84797
- Address
- 400 Interpace Pkwy
- Code information
- Lot #: 1332796 A, Exp 11/2020
- Postal code
- 07054-1120
- Report date
- Feb 19, 2020
- Product type
- Drugs
- Recall number
- D-0836-2020
- Classification
- Class II
- Recalling firm
- Teva Pharmaceuticals USA
- Termination date
- Nov 3, 2020
- Reason for recall
- CGMP deviations: Product bottle may be absent of desiccant.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Methylphenidate hydrochloride Extended-Release ablets USP (CII), 18 mg, 100-count bottle, Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 62037-725-01
- Distribution pattern
- USA Nationwide
- Recall initiation date
- Jan 27, 2020
- Initial firm notification
- Letter
- Center classification date
- Feb 10, 2020