FDA Drug Recalls

Recalls / Class II

Class IID-1080-2016

Product

All propylparaben Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.

Affected lot / code info
All lots compounded between 03/24/2015 and 03/24/2016 and within expiry.

Why it was recalled

Lack of Processing Controls

Recalling firm

Firm
Reliable Rexall-A Compounding Pharmacy
Notification channel
Press Release
Type
Voluntary: Firm initiated
Address
801 Irving St, N/A, San Francisco, California 94122-2310

Distribution

Quantity
N/A
Distribution pattern
U.S. Including: CA, HI, NM

Timeline

Recall initiated
2016-03-25
FDA classified
2016-07-06
Posted by FDA
2016-07-13
Terminated
2017-04-10
Status
Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-1080-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.

Class II recall: drug · FDA Drug Recalls