Multi-event July 2014 FDA Recall Drug by Fagron, Inc

This Multi-event Class II drug recall was voluntarily initiated by Fagron, Inc on July 24, 2014 for the product Drug. The FDA reported the reason for recall as microbial contamination of non-sterile products. The product was distributed Nationwide and the recall is currently terminated.

Reported Recall Events

D-1498-2014 TERMINATED D-1496-2014 TERMINATED D-1497-2014 TERMINATED

Recall Number: D-1498-2014

Reason for Recall
Microbial Contamination of Non-Sterile Products: Fagron is recalling six lots due to the presence of mold.
Initiated
07-24-2014
Reported
08-06-2014
Quantity
99 jars

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
68896
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.
Fagron, Inc
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 and Australia
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-21-2014
Product Description About Product Description
Full technical description of the product.
Fagron, Pentravan Plus Base 2.5 Kg, Article number: 804749. RX only, For prescription compounding, Oil-in-water emulsion base alternative to PLO gel, Added emulsifier ad viscosity-enhancing agent for use with high concentrations of active ingredients.Pre served and fragrance-free, Manufactured by: Fagron, Inc. 2400 Pilot Knob Rd, St. Paul, MN 55120, NDC 51552-1285-8,

Batch or Lot Expiration Information

Lot# 14C03-U09-017846; Exp. 03/17
Lot# 14B28-U06-017824; Exp. 03/17

Recall Number: D-1496-2014

Reason for Recall
Microbial Contamination of Non-Sterile Products: Fagron is recalling six lots due to the presence of mold.
Initiated
07-24-2014
Reported
08-06-2014
Quantity
430 jars

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
68896
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.
Fagron, Inc
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 and Australia
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-21-2014
Product Description About Product Description
Full technical description of the product.
Fagron, Phytobase Cream, 500 g, Article number: 802156. RX only, For prescription compounding Natural self-emulsifying oil-in water vehicle for oil-solvents ingredients. Contains Phytosomes (Plant Oil Bodies), Manufactured by Fagron, Inc. 2400 Pilot Knob Rd, St Paul, MN 55120, NDC 51552-1205-6.

Batch or Lot Expiration Information

Lot# 13J30-U17-015413; Exp 10/15
Lot# 13J30-U16-015425; Exp 10/15
Lot# 13I06-U05-014199; Exp 10/15

Recall Number: D-1497-2014

Reason for Recall
Microbial Contamination of Non-Sterile Products: Fagron is recalling six lots due to the presence of mold.
Initiated
07-24-2014
Reported
08-06-2014
Quantity
97 jars

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
68896
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.
Fagron, Inc
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 and Australia
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-21-2014
Product Description About Product Description
Full technical description of the product.
Fagron, Pentravan Base 2.5 Kg, Article number: 802486. RX only, For prescription compounding, Oil-in-water emulsion, PLO gel alternative, Preserved and fragrance-free, Manufactured by; Fagron, Inc. 2400 Pilot Knob Rd, St. Paul, MN 55120 NDC 51552-0919-8.

Batch or Lot Expiration Information

Lot# 14C24-U04-018189; Exp. 03/17
Lot# 14C26-U02-018214; Exp. 03/17