Recalls / Class II
Class IID-1417-2014
Product
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
- Affected lot / code info
- Lot # / Beyond Use Date: 05012014@36 / 05/15/14
Why it was recalled
Incorrect/Undeclared Excipients: Specific drug products were compounded with an incorrect solvent.
Recalling firm
- Firm
- Brookfield Prescription Center Inc. dba MD Custom Rx
- Notification channel
- Telephone
- Type
- Voluntary: Firm initiated
- Address
- 19035 W. Capitol Dr, Suite 105, Brookfield, Wisconsin 53045
Distribution
- Quantity
- 30 mL
- Distribution pattern
- WI only
Timeline
- Recall initiated
- 2014-05-30
- FDA classified
- 2014-07-03
- Posted by FDA
- 2014-07-09
- Terminated
- 2015-05-22
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1417-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.