Why it was recalled
Failed Dissolution Specifications: Product is being recalled due to out of specification dissolution results obtained during routine stability testing.
Product description
Methylphenidate Hydrochloride Extended-Release Capsules (LA), 20 mg, 100 count bottle, Rx only, TEVA PHARMACEUTICALS USA, NDC 0093-5346-01
Lot numbers, UPCs & expiration codes
34010282A, 34010283A, 34010284A, 34010285A, 34010286A and 34010565A, exp 04/14; 34013199A, 34013200A, 34013201A, 34013202A and 34013203A, exp 10/14.
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-847-2013
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jun 18, 2013
- FDA report date
- Aug 14, 2013
- Quantity
- 16,293 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Teva Pharmaceuticals USA, Inc.
Original FDA data
Every field from FDA enforcement report D-847-2013, exactly as published.
Show all FDA fields
- City
- Sellersville
- State
- PA
- Status
- Terminated
- Country
- United States
- Event ID
- 65515
- Address
- 650 Cathill Rd
- Code information
- 34010282A, 34010283A, 34010284A, 34010285A, 34010286A and 34010565A, exp 04/14; 34013199A, 34013200A, 34013201A, 34013202A and 34013203A, exp 10/14.
- Postal code
- 18960-1512
- Report date
- Aug 14, 2013
- Product type
- Drugs
- Recall number
- D-847-2013
- Classification
- Class II
- Recalling firm
- Teva Pharmaceuticals USA, Inc.
- Product quantity
- 16,293 bottles
- Termination date
- Aug 27, 2014
- Reason for recall
- Failed Dissolution Specifications: Product is being recalled due to out of specification dissolution results obtained during routine stability testing.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Methylphenidate Hydrochloride Extended-Release Capsules (LA), 20 mg, 100 count bottle, Rx only, TEVA PHARMACEUTICALS USA, NDC 0093-5346-01
- Distribution pattern
- Nationwide
- Recall initiation date
- Jun 18, 2013
- Initial firm notification
- Letter
- Center classification date
- Aug 7, 2013