D-0592-2018 Class II Terminated

Recalled by American Pharmaceutical Ingredients LLC — Waterford, MI

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
1460 GM

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.

Distribution Pattern

Nationwide in the USA.

Code Information

Lots: 071916-1, Exp. 07/08/2018; 080516-1, 080516-2, Exp. 07/22/2018; 101216-1, 011917C-1, Exp. 09/15/2018;