Multi-event February 2019 FDA Recall Drug by Avella Of Deer Valley, Inc. Store 38
This Multi-event Class II drug recall was voluntarily initiated by Avella Of Deer Valley, Inc. Store 38 on February 8, 2019 for the product Drug. The FDA reported the reason for recall as labeling. The product was distributed in Distribution to 13 states: Alabama, Arizona, California, Colorado, Florida, Idaho, Michigan, Minnesota, North Carolina, New Jersey, Oregon, Pennsylvania, Texas. and the recall is currently terminated.
Reported Recall Events
Recall Number: D-0999-2019
Labeling: Incorrect or Missing Lot and/or Exp Date:The product labels contain a Two-Dimensional ( 2D ) barcode that, when scanned, reveals information specific to the batch of the labeled product, including Expiration Date. The expiration date included within these 2D barcodes is incorrect and does not match the correct expiration date listed on the face of the label itself.
02-08-2019
02-20-2019
4,950 54 mL bags
Recall Profile & Regulatory Data
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.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Avella of Deer Valley, Inc. Store 38
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Distribution to 13 states: Alabama, Arizona, California, Colorado, Florida, Idaho, Michigan, Minnesota, North Carolina, New Jersey, Oregon, Pennsylvania, Texas.
02-25-2020
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
MAGnesium 2gm sulfate, added to D5W 50 mL, Volume: 54 mL, Sterile single use bag, Compounded by Avella Specialty Pharmacy 24416 N 19th Avenue, Phoenix, AZ 85085 (877) 794-0404, NDC 42852-902-05.
Batch or Lot Expiration Information
Lot# 138-20182509@110, 138-20182509@111; 138-20182509@112, BUD 12/24/2018; 138-20180210@76, 138-20180210@86, BUD 12/31/2018; 138-20180410@66, BUD 1/2/2019; 138-20183110@43, 138-20183110@44, BUD 1/29/2019; 138-20180111@84, 138-20180111@85, BUD 1/30/2019; 138-20180611@36, 138-20180611@39, 138-20180611@52, 138-20180611@60, BUD 2/4/2019; 138-20181911@125; 138-20181911@126, BUD 2/17/2019; 138-20182011@56, BUD 2/18/2019.
Recall Number: D-0998-2019
Labeling: Incorrect or Missing Lot and/or Exp Date:The product labels contain a Two-Dimensional ( 2D ) barcode that, when scanned, reveals information specific to the batch of the labeled product, including Expiration Date. The expiration date included within these 2D barcodes is incorrect and does not match the correct expiration date listed on the face of the label itself.
02-08-2019
02-20-2019
250 52 mL bags
Recall Profile & Regulatory Data
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.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Avella of Deer Valley, Inc. Store 38
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Distribution to 13 states: Alabama, Arizona, California, Colorado, Florida, Idaho, Michigan, Minnesota, North Carolina, New Jersey, Oregon, Pennsylvania, Texas.
02-25-2020
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
MAGnesium 1gm sulfate, added to D5W 50 mL, Volume 52 mL, sterile single use bag, Compounded by Avella Specialty Pharmacy 24416 N 19th Avenue, Phoenix, AZ 85085 (877) 794-0404, NDC 42852-901-05.
Batch or Lot Expiration Information
Lot# Lot number: 138-20182409@31, BUD 12/23/2018
Recall Number: D-0997-2019
Labeling: Incorrect or Missing Lot and/or Exp Date:The product labels contain a Two-Dimensional ( 2D ) barcode that, when scanned, reveals information specific to the batch of the labeled product, including Expiration Date. The expiration date included within these 2D barcodes is incorrect and does not match the correct expiration date listed on the face of the label itself.
02-08-2019
02-20-2019
2,840 4mL syringes
Recall Profile & Regulatory Data
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.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Avella of Deer Valley, Inc. Store 38
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Distribution to 13 states: Alabama, Arizona, California, Colorado, Florida, Idaho, Michigan, Minnesota, North Carolina, New Jersey, Oregon, Pennsylvania, Texas.
02-25-2020
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Labetalol 20mg, HCL, USP Injectable Solution, 20mg/4mL (5 mg per mL), 4mL single use syringe. Repackaged by Avella Specialty Pharmacy 24416 N 19th Avenue, Phoenix, AZ 85085 (877) 794-0404, NDC 42852-822-71.
Batch or Lot Expiration Information
Lot# 138-20182712@49, BUD 4/6/2019; 138-20182712@63, BUD 4/6/2019; 138-20182712@89, BUD 4/6/2019; 138-20182712@90, BUD 4/6/2019; 138-20182712@93, BUD 4/6/2019; 138-20183112@88, BUD 4/10/2019; 138-20183112@89, BUD 4/10/2019;138-20183112@91, BUD 4/10/2019; 138-20190201@96, BUD 4/12/2019
Recall Number: D-1000-2019
Labeling: Incorrect or Missing Lot and/or Exp Date:The product labels contain a Two-Dimensional ( 2D ) barcode that, when scanned, reveals information specific to the batch of the labeled product, including Expiration Date. The expiration date included within these 2D barcodes is incorrect and does not match the correct expiration date listed on the face of the label itself.
02-08-2019
02-20-2019
8,500 54 mL bags
Recall Profile & Regulatory Data
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.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Avella of Deer Valley, Inc. Store 38
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Distribution to 13 states: Alabama, Arizona, California, Colorado, Florida, Idaho, Michigan, Minnesota, North Carolina, New Jersey, Oregon, Pennsylvania, Texas.
02-25-2020
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
MAGnesium 2 gm sulfate, added to NS 50 mL, Sterile single use bag, 54 mL, Compounded by Avella Specialty Pharmacy 24416 N 19 th Avenue, Phoenix, AZ 85085 (877) 794-0404, NDC 42852-907-05.
Batch or Lot Expiration Information
Lot# 138-20181909@53, BUD 12/18/2018; 138-20182009@10, 138-20182009@2, 138-20182009@3, 138-20182009@4, 138-20182009@5, 138-20182009@6, 138-20182009@7, 138-20182009@8, 138-20182009@9, BUD 12/19/2018; 138-20182109@35, BUD 12/20/2018; 138-20180410@54, BUD 1/2/2019; 138-20180510@107, 138-20180510@108, 138-20180510@92, BUD 1/3/2019; 138-20182210@97, BUD 1/20/2019; 138-20181212@103, BUD 3/12/2019.
