April 2017 FDA Recall Drug by American Pharmaceutical Ingredients Llc
D-0919-2017 - cGMP Deviations; lack of quality assurance.

This Class II drug recall was voluntarily initiated by American Pharmaceutical Ingredients Llc on April 17, 2017 for the product Drug. The FDA reported the reason for recall as cgmp deviations; lack of quality assurance.. The product was distributed in NY, GA, NV, CA, KY, TX and the recall is currently terminated.

Recall Number: D-0919-2017

Reason for Recall
cGMP Deviations; lack of quality assurance.
Initiated
04-17-2017
Reported
06-21-2017
Quantity
1g=1 bottle; 5g=4 bottle; 25g=3 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
77465
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.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
NY, GA, NV, CA, KY, TX
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-31-2018
Product Description About Product Description
Full technical description of the product.
ESTRONE USP, packaged in a) 1g bottle (NDC: 58597-8049-2), c) 5g bottle (NDC: 58597-8049-3), d) 25g bottle (NDC: 58597-8049-4), For Prescription Compounding, RX Only, Packed under cGMP conditions by American Pharmaceutical Ingredients, LLC, 6650 Highland Road, Waterford, MI 48327

Batch or Lot Expiration Information

Lot# Lots: 052915-1, 052915-2, exp 5/5/2017