FDA recall D-0011-2015
Unique Pharmaceutical, Ltd · Class I · drug
Product
N-Acetyl Cysteine 20% 4 mL Vial Stock Code: 4133
Reason for recall
Non-Sterility: One lot of N-Acetyl Cysteine vials tested positive for Herbaspirillum huttiense.
Distribution
Nationwide
Key facts
- Status
- Terminated
- Initiation date
- 2014-07-18
- Report date
- 2014-10-15
- Termination date
- 2016-02-24
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Temple, TX, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0011-2015