FDA recall D-0136-2019
Pharm D Solutions, LLC · Class II · drug
Product
Acetylcysteine Injection 10 mg/5 mL (2 mg/mL), Pharm D Solutions, Houston, Texas ---- NDC 69699-1424-10
Reason for recall
Lack of Assurance of Sterility
Distribution
Nationwide
Key facts
- Status
- Terminated
- Initiation date
- 2018-09-10
- Report date
- 2018-11-07
- Termination date
- 2021-02-05
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Houston, TX, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0136-2019