Recalls / Class II
Class IID-0591-2018
Product
Oxytocin USP, powder, 1g-bottle, API American Pharmaceutical Ingredients, NDC 58597-7042-3
- Affected lot / code info
- Lot 012517-1R
Why it was recalled
Stability Data Does Not Support Expiry: Stability data from manufacturer does not support expiration dates listed.
Recalling firm
- Firm
- American Pharmaceutical Ingredients LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 6650 Highland Rd Ste 302, Waterford, Michigan 48327-1665
Distribution
- Quantity
- 21 g
- Distribution pattern
- Nationwide in the USA.
Timeline
- Recall initiated
- 2018-03-07
- FDA classified
- 2018-03-12
- Posted by FDA
- 2018-03-21
- Terminated
- 2019-12-02
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0591-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.