Recalls affecting Puerto Rico

A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:

D-0307-2019

Lot/product code:

NDC 0093-7807-56 & 0093-7807-98 Lot # 18X010, 18X011

Recalling firm:

Teva Pharmaceuticals USA

A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:

D-0303-2019

Lot/product code:

NDC 0093-7690-56 & NDC 0093-7690-98 Lot # 23X017, 23X018, 23X019, 23X020, 23X022, 23X023, 23X024

Recalling firm:

Teva Pharmaceuticals USA

A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:

D-0306-2019

Lot/product code:

NDC 0093-7693-56 & NDC 0093-7693-98 Lot # 26X036, 26X038, 26X039, 26X040, 26X041, 26X042, 26X043, 26X044, 26X045, 26X046, 26X047, 26X048, 26X049, 26X050, 26X051

Recalling firm:

Teva Pharmaceuticals USA

A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:

D-0309-2019

Lot/product code:

NDC 0093-7038-56 & NDC 0093-7038-98 Lot # 21X006, 21X007

Recalling firm:

Teva Pharmaceuticals USA

A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:

D-0305-2019

Lot/product code:

NDC 0093-7692-56 & NDC 0093-7692-98 Lot # 25X028, 25X029, 25X030, 25X031, 25X032, 25X035, 25X037

Recalling firm:

Teva Pharmaceuticals USA

FDA has not published a risk classification for this recall yet.

Recall #:

81747

Lot/product code:

IntellaNav Open-Irrigated Ablation Catheter Material Number: M004R96200 Batch: 22208397 Expiration Date: 6/4/2021 Batch: 22389516 Expiration Date: 7/16/2021 Batch: 22525798 Expiration Date: 2/14/2020

Recalling firm:

Boston Scientific Corporation

FDA has not published a risk classification for this recall yet.

Recall #:

81747

Lot/product code:

IntellaTip MiFi Open-Irrigated Ablation Catheter Material Number: M004PM96200 Batch: 20368736 Expiration Date: 3/5/2020 Batch: 20531648 Expiration Date: 4/16/2020 Batch: 20560477 Expiration Date: 4/23/2020 Batch: 20566637 Expiration Date: 4/24/2020 Batch: 20628704 Expiration Date: 5/9/2020 Batch: 20628705 Expiration Date: 5/10/2020 Batch: 20763900 Expiration Date: 6/12/2020 Batch: 20769113 Expiration Date: 6/13/2020 Batch: 21318000 Expiration Date: 10/29/2020 Batch: 21318001 Expiration Date: 10/29/2020 Batch: 21357647 Expiration Date: 11/10/2020 Batch: 21463186 Expiration Date: 12/3/2020 Batch: 21543193 Expiration Date: 12/20/2020 Batch: 21574774 Expiration Date: 1/4/2021 Batch: 22195929 Expiration Date: 5/31/2021 Batch: 22202991 Expiration Date: 6/3/2021 Batch: 22290601 Expiration Date: 6/3/2021 Batch: 22305067 Expiration Date: 6/25/2021 Batch: 22315782 Expiration Date: 6/27/2021 Batch: 22317356 Expiration Date: 6/28/2021 Batch: 22327178 Expiration Date: 7/1/2021 Batch: 22329367 Expiration Date: 7/2/2021 Batch: 22330626 Expiration Date: 7/2/2021 Batch: 22371866 Expiration Date: 7/12/2021 Batch: 22371868 Expiration Date: 7/12/2021 Batch: 22379905 Expiration Date: 7/15/2021 Batch: 22435929 Expiration Date: 7/26/2021 Batch: 22435930 Expiration Date: 7/26/2021 Batch: 22438118 Expiration Date: 7/27/2021 Batch: 22455198 Expiration Date: 7/31/2021 Batch: 22499957 Expiration Date: 8/10/2021 Material Number: M004PM9620K20 Batch: 20371559 Expiration Date: 3/6/2020 Batch: 20542305 Expiration Date: 4/18/2020 Batch: 20548241 Expiration Date: 4/19/2020 Batch: 20639975 Expiration Date: 5/14/2020 Batch: 20677314 Expiration Date: 5/21/2020 Batch: 20772834 Expiration Date: 6/14/2020 Batch: 22321772 Expiration Date: 6/29/2021 Batch: 22326857 Expiration Date: 7/1/2021 Material Number: M004PM9620N40 Batch: 20371742 Expiration Date: 3/8/2020 Batch: 20463744 Expiration Date: 3/28/2020 Batch: 20622763 Expiration Date: 5/8/2020 Batch: 20775597 Expiration Date: 6/14/2020 Batch: 22340824 Expiration Date: 7/4/2021 Batch: 22371871 Expiration Date: 7/12/2021 Batch: 22374909 Expiration Date: 7/13/2021

Recalling firm:

Boston Scientific Corporation

FDA has not published a risk classification for this recall yet.

Recall #:

81747

Lot/product code:

Blazer Open Irrigated Ablation Catheter Material Number: M00496200, Batch: 20399570, Expiration Date: 3/13/2020 Batch: 21778776, Expiration Date: 2/21/2021 Batch: 22152470, Expiration Date: 5/21/2021 Batch: 22499259, Expiration Date: 8/13/2001 Material Number: M0049620N40 Batch::20413170, Expiration Date: 3/16/2020 Batch: 20809676, Expiration Date: 6/22/2020  Material Number: M0049620K20  Batch: 20403945, Expiration Date: 3/13/2020

Recalling firm:

Boston Scientific Corporation

A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:

D-0323-2019

Lot/product code:

Lot Numbers: 3066064, 3069645, 3069646, 3073142, 3073143, 3073144, 3077617

Recalling firm:

Mylan Laboratories Limited, (Nashik FDF)

A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:

D-0328-2019

Lot/product code:

Lot numbers: 3084363, 3084364, 3093800, 3084363, 3093800

Recalling firm:

Mylan Laboratories Limited, (Nashik FDF)

A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:

D-0329-2019

Lot/product code:

Lot numbers: 2008880 3084358 3084359 3093801 3084359 3084361 3093801

Recalling firm:

Mylan Laboratories Limited, (Nashik FDF)

A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:

D-0325-2019

Lot/product code:

Lot Numbers: 3065445, 3074880, 3074883, 3086688, 3086689, 3086710

Recalling firm:

Mylan Laboratories Limited, (Nashik FDF)

A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:

D-0330-2019

Lot/product code:

Lot numbers: 3084887 3093802 3084887 3084888 3093802

Recalling firm:

Mylan Laboratories Limited, (Nashik FDF)

A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:

D-0327-2019

Lot/product code:

Lot Numbers: 3063783 3063784 3063785 3064092 3064093 3064094 3070349 3070350 3070351 3070352 3070353 3070354 3079030 3079031 3079032 3079033 3080011 3080224 3081498 3081500 3087126 3088476

Recalling firm:

Mylan Laboratories Limited, (Nashik FDF)

A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:

D-0324-2019

Lot/product code:

Lot Numbers: 3063780, 3074879, 3086684, 3086687

Recalling firm:

Mylan Laboratories Limited, (Nashik FDF)

A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:

D-0332-2019

Lot/product code:

Lot numbers: 3084860 3084861 3084862 3093804 3084862 3084863

Recalling firm:

Mylan Laboratories Limited, (Nashik FDF)

A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:

D-0322-2019

Lot/product code:

Lot Numbers: 3064086, 3066061, 3066062,3073145,3073146,3073147, 3076091, 3077619, 3082432

Recalling firm:

Mylan Laboratories Limited, (Nashik FDF)

A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:

D-0321-2019

Lot/product code:

Lot numbers: 3064085, 3066063,3069638,3069639

Recalling firm:

Mylan Laboratories Limited, (Nashik FDF)

A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:

D-0326-2019

Lot/product code:

Lot Numbers: 3069019, 3069020, 3069021, 3069022, 3071354, 3071355, 3071357 3079023 3079027 3079028 3079029 3079996 3079997 3079998 3083635 3086715 3086716 3086717 3088623

Recalling firm:

Mylan Laboratories Limited, (Nashik FDF)

A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:

D-0320-2019

Lot/product code:

Lot Numbers:3064084, 3069629, 3073148, 3073149,3076093, 3077772

Recalling firm:

Mylan Laboratories Limited, (Nashik FDF)

A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:

D-0331-2019

Lot/product code:

Lot numbers: 3084889 3084890 3093803

Recalling firm:

Mylan Laboratories Limited, (Nashik FDF)

FDA has not published a risk classification for this recall yet.

Recall #:

81750

Lot/product code:

Product Code A319418AM;  Lot NGCT1929;  Exp. Date 11/30/2018

Recalling firm:

Bard Medical Division

FDA has not published a risk classification for this recall yet.

Recall #:

81785

Lot/product code:

MOSAIQ Radiation Oncology version 1.0 and higher. Multi-ACCESS version 6.1 and higher.   UDI 858164002084 858164002091 858164002107 858164002220 858164002237

Recalling firm:

Elekta, Inc.

A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:

D-0502-2019

Lot/product code:

Count, lots, expiry: [30-count bottle] Lot 4L67C035, exp 10/2019; [90-count bottle] Lot 4L67C035, 4L67C036 exp 10/2019; [1000-count bottle] Lot 4O50C005, exp 11/2019

Recalling firm:

Torrent Pharma Inc.

A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:

D-0504-2019

Lot/product code:

Count, lots, expiry: [90-count bottle] Lot BX35C020, exp 05/2019, Lot BX35C049, exp 08/2019; [1000-count bottle] Lots BX35C022, BX35C023, exp 05/2019

Recalling firm:

Torrent Pharma Inc.