D-0591-2018 Class II Terminated
FDA drug recall D-0591-2018 was initiated by American Pharmaceutical Ingredients LLC on March 7, 2018 and is designated Class II. Reason for recall: Stability Data Does Not Support Expiry: Stability data from manufacturer does not support expiration dates listed. The recall status is terminated (terminated December 2, 2019). Affected quantity: 21 g.
Recall Details
- Product Type
- Drugs
- Report Date
- March 21, 2018
- Initiation Date
- March 7, 2018
- Termination Date
- December 2, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 21 g
Product Description
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 Pattern
Nationwide in the USA.
Code Information
Lot 012517-1R