FDA recall D-0591-2018
American Pharmaceutical Ingredients LLC · Class II · drug
Product
Oxytocin USP, powder, 1g-bottle, API American Pharmaceutical Ingredients, NDC 58597-7042-3
Reason for recall
Stability Data Does Not Support Expiry: Stability data from manufacturer does not support expiration dates listed.
Distribution
Nationwide in the USA.
Key facts
- Status
- Terminated
- Initiation date
- 2018-03-07
- Report date
- 2018-03-21
- Termination date
- 2019-12-02
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Waterford, MI, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0591-2018