Multi-event September 2013 FDA Recall Drug by Apothecary Shoppe

This Multi-event Class II drug recall was voluntarily initiated by Apothecary Shoppe on September 6, 2013 for the product Drug. The FDA reported the reason for recall as lack of assurance of sterility. The product was distributed in Oklahoma and the recall is currently terminated.

Reported Recall Events

D-66241-001 TERMINATED D-66241-002 TERMINATED

Recall Number: D-66241-001

Reason for Recall
Lack of Assurance of Sterility: concerns of sterility assurance with the pharmacy's independent testing laboratory.
Initiated
09-06-2013
Reported
10-09-2013
Quantity
3540 mL

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
66241
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 Shoppe
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.
Oklahoma
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-08-2016
Product Description About Product Description
Full technical description of the product.
Estradiol 1.25 mg, Progesterone 25 mg/mL injectable, 20 mL sterile vials, The Apothecary Shoppe, 6136 E. 51st St. Tulsa, OK 74135.

Batch or Lot Expiration Information

Lot# Lot 05022013@20, Exp 10/29/13

Recall Number: D-66241-002

Reason for Recall
Lack of Assurance of Sterility: concerns of sterility assurance with the pharmacy's independent testing laboratory
Initiated
09-06-2013
Reported
10-09-2013
Quantity
1,430 mL

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
66241
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 Shoppe
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.
Oklahoma
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-08-2016
Product Description About Product Description
Full technical description of the product.
SIH-Testosterone Cypionate 200 mg/mL Injectable, 10 mL sterile vial, The Apothecary Shoppe, 6136 E. 51st St. Tulsa, OK 74135.

Batch or Lot Expiration Information

Lot# s: 05132013@25, Exp 11/9/13; 08072013@4, Exp 2/3/14