FDA recall D-633-2013

Product

Acetylcysteine 20 % solution, 100 ml bottle, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907

Reason for recall

Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.

Distribution

FL, GA and SC.

Key facts

Status

Terminated

Initiation date

2013-03-20

Report date

2013-07-10

Termination date

2017-02-22

Voluntary/Mandated

Voluntary: Firm initiated

Location

Augusta, GA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-633-2013