Multi-event March 2018 FDA Recall Drug by American Pharmaceutical Ingredients Llc

This Multi-event Class II drug recall was voluntarily initiated by American Pharmaceutical Ingredients Llc on March 7, 2018 for the product Drug. The FDA reported the reason for recall as stability data does not support expiry. The product was distributed Nationwide and the recall is currently terminated.

Reported Recall Events

D-0592-2018 TERMINATED D-0591-2018 TERMINATED

Recall Number: D-0592-2018

Reason for Recall
Stability Data Does Not Support Expiry: Stability data from manufacturer does not support expiration dates listed.
Initiated
03-07-2018
Reported
03-21-2018
Quantity
1460 GM

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
79420
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
American Pharmaceutical Ingredients LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-02-2019
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration Information

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

Recall Number: D-0591-2018

Reason for Recall
Stability Data Does Not Support Expiry: Stability data from manufacturer does not support expiration dates listed.
Initiated
03-07-2018
Reported
03-21-2018
Quantity
21 g

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
79420
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
American Pharmaceutical Ingredients LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-02-2019
Product Description About Product Description
Full technical description of the product.
Oxytocin USP, powder, 1g-bottle, API American Pharmaceutical Ingredients, NDC 58597-7042-3

Batch or Lot Expiration Information

Lot# Lot 012517-1R