Multi-event February 2019 FDA Recall Drug by Advanced Pharma Inc.

This Multi-event Class III drug recall was voluntarily initiated by Advanced Pharma Inc. on February 6, 2019 for the product Drug. The FDA reported the reason for recall as superpotent drug. The product was distributed Nationwide and the recall is currently terminated.

Reported Recall Events

D-0497-2019 TERMINATED D-0498-2019 TERMINATED D-0499-2019 TERMINATED

Recall Number: D-0497-2019

Reason for Recall
Superpotent Drug: product may contain concentrations of oxytocin higher than what is represented on the label.
Initiated
02-06-2019
Reported
02-27-2019
Quantity
12 bags

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
82089
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Advanced Pharma 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 in the USA.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-30-2019
Product Description About Product Description
Full technical description of the product.
Oxytocin 10 Units added to NS 1000 mL (oxytocin and 0.9% Sodium Chloride) Injectable Solution, Approximately 1001 mL Sterile single use bag, Rx only, Avella of Houston, 9265 Kirby Dr., Houston, TX 77054, NDC 42852-730-99.

Batch or Lot Expiration Information

Lot# Lot: 12/20/18 1056 73099P, BUD: 02/03/2019

Recall Number: D-0498-2019

Reason for Recall
Superpotent Drug: product may contain concentrations of oxytocin higher than what is represented on the label.
Initiated
02-06-2019
Reported
02-27-2019
Quantity
672 bags

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
82089
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Advanced Pharma 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 in the USA.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-30-2019
Product Description About Product Description
Full technical description of the product.
Oxytocin 20 Units added to NS 1000 mL (oxytocin and 0.9% Sodium Chloride) Injectable Solution, Approximately 1002 mL Sterile single use bag, Rx only, Avella of Houston, 9265 Kirby Dr., Houston, TX 77054, NDC 42852-703-99.

Batch or Lot Expiration Information

Lot# Lots: 12/14/18 1482 70399P, BUD: 02/27/19; 12/14/18 1610 70399P, BUD: 02/27/19

Recall Number: D-0499-2019

Reason for Recall
Superpotent Drug: product may contain concentrations of oxytocin higher than what is represented on the label.
Initiated
02-06-2019
Reported
02-27-2019
Quantity
1460 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
82089
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Advanced Pharma 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 in the USA.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-30-2019
Product Description About Product Description
Full technical description of the product.
Oxytocin 30 Units added to NS 500 mL (oxytocin and 0.9% Sodium Chloride) Injectable Solution, Approximately 503 mL Sterile single use bag, Rx only, Avella of Houston, 9265 Kirby Dr., Houston, TX 77054, NDC 42852-706-50.

Batch or Lot Expiration Information

Lot# Lots: 11/27/18 3177 70650P, BUD: 02/10/2019; 11/27/18 6618 70650P, BUD: 02/10/2019; 11/28/18 7716 70650P, BUD: 02/12/19; 12/31/18 5698 70650P, BUD: 03/16/19