Class III
Terminated
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
This recall has been terminated (originally issued May 9, 2018).
- Company
- Rhodes Pharmaceuticals, L.P.
- Recall Initiated
- April 17, 2018
- Posted
- May 9, 2018
- Recall Number
- D-0710-2018
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 2454 bottles
- Firm Location
- Coventry, RI, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Failed Dissolution Specification: Low dissolution outside of specifications
Distribution
Nationwide within the USA
Lot / Code Info
Lot# AG8679B Exp. 01/2020
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