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
Reported: May 9, 2018 Initiated: April 17, 2018 #D-0710-2018
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
Reason for Recall
Failed Dissolution Specification: Low dissolution outside of specifications
Details
- Recalling Firm
- Rhodes Pharmaceuticals, L.P.
- Units Affected
- 2454 bottles
- Distribution
- Nationwide within the USA
- Location
- Coventry, RI
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Rhodes Pharmaceuticals, L.P.. Units affected: 2454 bottles.
Why was this product recalled? ▼
Failed Dissolution Specification: Low dissolution outside of specifications
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on May 9, 2018. Severity: Low. Recall number: D-0710-2018.
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