Why it was recalled
Failed Dissolution Specification: Low dissolution outside of specifications
Product description
Aptensio XR (methylphenidate HCl extended-release) capsules 15 mg Rx Only 90-count bottle. Marketed by: Rhodes Pharmaceuticals L.P., Coventry, RI 02816. Manufactured by: Patheon Manufacturing Services LLC, Greenville, NC 27834. NDC 42858-402-45
Lot numbers, UPCs & expiration codes
Lot# AG8679B Exp. 01/2020
Where it was sold
Nationwide within the USA
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-0710-2018
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Apr 17, 2018
- FDA report date
- May 9, 2018
- Quantity
- 2454 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Rhodes Pharmaceuticals, L.P.
Original FDA data
Every field from FDA enforcement report D-0710-2018, exactly as published.
Show all FDA fields
- City
- Coventry
- State
- RI
- Status
- Terminated
- Country
- United States
- Event ID
- 79820
- Address
- 498 Washington St
- Code information
- Lot# AG8679B Exp. 01/2020
- Postal code
- 02816-5467
- Report date
- May 9, 2018
- Product type
- Drugs
- Recall number
- D-0710-2018
- Classification
- Class III
- Recalling firm
- Rhodes Pharmaceuticals, L.P.
- Product quantity
- 2454 bottles
- Termination date
- May 19, 2020
- Reason for recall
- Failed Dissolution Specification: Low dissolution outside of specifications
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Aptensio XR (methylphenidate HCl extended-release) capsules 15 mg Rx Only 90-count bottle. Marketed by: Rhodes Pharmaceuticals L.P., Coventry, RI 02816. Manufactured by: Patheon Manufacturing Services LLC, Greenville, NC 27834. NDC 42858-402-45
- Distribution pattern
- Nationwide within the USA
- Recall initiation date
- Apr 17, 2018
- Initial firm notification
- Letter
- Center classification date
- May 3, 2018