PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: March 21, 2018 Initiated: March 7, 2018 #D-0592-2018

Product Description

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

Reason for Recall

Stability Data Does Not Support Expiry: Stability data from manufacturer does not support expiration dates listed.

Details

Units Affected
1460 GM
Distribution
Nationwide in the USA.
Location
Waterford, MI

Frequently Asked Questions

What product was recalled?
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. Recalled by American Pharmaceutical Ingredients LLC. Units affected: 1460 GM.
Why was this product recalled?
Stability Data Does Not Support Expiry: Stability data from manufacturer does not support expiration dates listed.
Which agency issued this recall?
This recall was issued by the FDA Drug on March 21, 2018. Severity: Moderate. Recall number: D-0592-2018.