Multi-event September 2016 FDA Recall Drug by The Apothecary Shoppe Llc

This Multi-event Class II drug recall was voluntarily initiated by The Apothecary Shoppe Llc on September 12, 2016 for the product Drug. The FDA reported the reason for recall as lack of assurance of sterility; medication was sterilized with a recalled filter. The product was distributed in Oklahoma and the recall is currently terminated.

Reported Recall Events

D-0002-2017 TERMINATED D-0004-2017 TERMINATED D-0003-2017 TERMINATED

Recall Number: D-0002-2017

Reason for Recall
Lack of Assurance of Sterility; medication was sterilized with a recalled filter
Initiated
09-12-2016
Reported
10-12-2016
Quantity
419 mL total

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
75212
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.
The Apothecary Shoppe 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.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Oklahoma
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-25-2018
Product Description About Product Description
Full technical description of the product.
Methylcobalamin 5000 mcg/mL Injection, packaged in 1, 2, 3, 4, and 5 mL vials, IM, Rx, The Apothecary Shoppe Compounding Pharmacy, Jenks, OK

Batch or Lot Expiration Information

Lot# 071222016@24 BUD 01/08/2017, 05112016@8 BUD 11/07/2016

Recall Number: D-0004-2017

Reason for Recall
Lack of Assurance of Sterility; medication was sterilized with a recalled filter
Initiated
09-12-2016
Reported
10-12-2016
Quantity
247.5 mL total volume

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
75212
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.
The Apothecary Shoppe 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.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Oklahoma
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-25-2018
Product Description About Product Description
Full technical description of the product.
Tri-Mix 18/1/10 (Papaverine 18mg, Phentolamine 1 mg, Prostaglandin 10 mcg/mL) packaged in 2.5 mL sterile vials, IM, Rx, The Apothecary Shoppe, Jenks, OK

Batch or Lot Expiration Information

Lot# 07252016@22 BUD 09/22/2016; 08102016@28 BUD 10/08/2016

Recall Number: D-0003-2017

Reason for Recall
Lack of Assurance of Sterility; medication was sterilized with a recalled filter
Initiated
09-12-2016
Reported
10-12-2016
Quantity
455 mL total volume

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
75212
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.
The Apothecary Shoppe 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.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Oklahoma
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-25-2018
Product Description About Product Description
Full technical description of the product.
Phenotolamine 0.4mg/Prostaglandin 20mcg/mL packaged in 2.5 mL sterile vials, IM, Rx, The Apothecary Shoppe, Jenks, OK

Batch or Lot Expiration Information

Lot# 05162016@18 BUD 09/13/2016; 07052016@9 BUD 11/02/2016; 08032016@13 BUD 12/01/2016