D-1417-2014 Class II Terminated
FDA drug recall D-1417-2014 was initiated by Brookfield Prescription Center Inc. dba MD Custom Rx on May 30, 2014 and is designated Class II. Reason for recall: Incorrect/Undeclared Excipients: Specific drug products were compounded with an incorrect solvent. The recall status is terminated (terminated May 22, 2015). Affected quantity: 30 mL.
Recall Details
- Product Type
- Drugs
- Report Date
- July 9, 2014
- Initiation Date
- May 30, 2014
- Termination Date
- May 22, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 30 mL
Product Description
Diphenhydramine (Alcohol Base) 25 mg / 0.5 mL Solution, 30 mL bottle, Rx only, MD Custom Rx, 19035 W. Capitol Dr., Ste. 105, Brookfield, WI 53045
Reason for Recall
Incorrect/Undeclared Excipients: Specific drug products were compounded with an incorrect solvent.
Distribution Pattern
WI only
Code Information
Lot # / Beyond Use Date: 05012014@36 / 05/15/14