Recalls / Class II
Class IID-0592-2018
Product
Sermorelin Acetate, powder, a) 1 GM-bottle (NDC58597-8092-1) b) 5 GM-bottle (NDC 58597-8092-2) c) 10 GM-bottle (NDC 58597-8092-4) API American Pharmaceutical Ingredients
- Affected lot / code info
- Lots: 071916-1, Exp. 07/08/2018; 080516-1, 080516-2, Exp. 07/22/2018; 101216-1, 011917C-1, Exp. 09/15/2018;
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
- 1460 GM
- 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-0592-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.