Recall Record

Phoenix, AZ, United States

Avella of Deer Valley, Inc. Store 38 recalls

6 recalls recorded since 2018, most recently on 18 September 2019. None are listed as ongoing. Status and classification are as published by the FDA.

Recalls6
Ongoing (FDA)0
Terminated or completed6
Class I (FDA)0

Terminated Class II Drugs

Recall started
18 September 2019
Terminated
4 December 2019
Reason
Lack of sterility assurance.
Distribution
Nationwide within the United States
Recall number
D-0152-2020

Terminated Class II Drugs

Recall started
3 May 2019
Terminated
25 February 2020
Reason
Lack of assurance of sterility
Distribution
U.S.A. nationwide
Initiated
Voluntary: Firm initiated
Recall number
D-1308-2019

Terminated Class II Drugs

Recall started
8 February 2019
Terminated
25 February 2020
Reason
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.
Distribution
Distribution to 13 states: Alabama, Arizona, California, Colorado, Florida, Idaho, Michigan, Minnesota, North Carolina, New Jersey, Oregon, Pennsylvania, Texas.
Initiated
Voluntary: Firm initiated
Recall numbers
D-1000-2019, D-0997-2019, D-0998-2019, D-0999-2019

Terminated Class II Drugs

Recall started
31 October 2018
Terminated
18 January 2019
Reason
Lack of Assurance of Sterility
Distribution
Product was distributed throughout the United States.
Initiated
Voluntary: Firm initiated
Recall number
D-0224-2019

Terminated Class II Drugs

Recall started
19 October 2018
Terminated
6 May 2021
Reason
Lack of assurance of sterility
Distribution
U.S.A. nationwide.
Initiated
Voluntary: Firm initiated
Recall numbers
D-0134-2019, D-0131-2019, D-0135-2019, D-0132-2019, D-0133-2019

Terminated Class II Drugs

Recall started
12 June 2018
Terminated
24 January 2020
Reason
Lack of Assurance of Sterility: Potential leakage of bags.
Distribution
Nationwide in the USA
Initiated
Voluntary: Firm initiated
Recall numbers
D-0942-2018, D-0933-2018, D-0964-2018, D-0956-2018, D-0949-2018, D-0929-2018, D-0943-2018, D-0940-2018, D-0939-2018, D-0959-2018, D-0934-2018, D-0954-2018 and 26 more

A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.