June 2017 FDA Recall Drug by Apothecary By Design
D-0924-2017 - Lack of Processing Controls

This Class II drug recall was voluntarily initiated by Apothecary By Design on June 5, 2017 for the product Drug. The FDA reported the reason for recall as lack of processing controls. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0924-2017

Reason for Recall
Lack of Processing Controls: The metal container closure adheres to the rubber stopper on some of the units of the batch which can impact the integrity of the container closure.
Initiated
06-05-2017
Reported
07-05-2017
Quantity
25 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
77615
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.
Apothecary By Design
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.
Telephone
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.
10-06-2017
Product Description About Product Description
Full technical description of the product.
Progesterone Injection in Olive Oil With Benzyl Alcohol 10%, 50mg/mL, 10mL Multi-Dose Vial, Rx only, Apothecary by Design, 141 Preble Street, Portland, ME.

Batch or Lot Expiration Information

Lot# : 04192017@1, Exp 09/30/2017