The Recall Desk

Archive

June 2019 recalls

686 recalls were announced in June 2019.

What the numbers show

Critical
12
Severe
191
High
347
Moderate
123
Low
13

Of the 686 recalls this month scored against our rubric, 2% are Critical, 28% are Severe.

101–200 of 686

  • ModerateFDA (Drugs)·D-1448-2019·2019-06-26

    Zydus Recalls Methylprednisolone Tablets Due to Cross-Contamination

    Zydus Pharmaceuticals is recalling specific lots of Methylprednisolone tablets due to cross-contamination caused by cleaning failures.

    Product
    METHYLPREDNISOLONE — METHYLPREDNISOLONE (METHYLPREDNISOLONE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1814-2019·2019-06-26

    Arrow JACC Medical Device Recalled for Incorrect Expiration Date

    Arrow International Inc. is recalling Arrow JACC devices with Chloraguard Technology due to an incorrect expiration date on the packaging.

    Product
    Arrow¿ JACC with Chlorag+ard Technology Product Code: JR 42541 HPHNM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1845-2019·2019-06-26

    Zimmer Biomet Recalls Mobi-C Distraction Screws Due to Labeling Error

    Zimmer Biomet is recalling 313 Mobi-C 14mm Distraction Screws because they were incorrectly labeled as 12mm length screws.

    Product
    Mobi-C 14mm Distraction Screw, Quick Start. Intended for cervical intervertebral disc replacement. Item Number: 0024-LDR TEDAN SURGICAL INNOVATIONS LLC DISTRIBUTED BY: LDR SPINE USA, INC., 13785 RESEARCH BLVD, SUITE 200- AUSTIN, TX 78750 Product Usage: The device is intende
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1388-2019·2019-06-26

    Sun Pharmaceutical Recalls Allergy Relief D Tablets Due to Impurities

    Sun Pharmaceutical is recalling Allergy Relief D tablets because testing showed impurities above or near specification limits.

    Product
    Allergy Relief D, Fexofenadine HCl 60 mg/ Pseudoephedrine HCl 120 mg, Extended Release Tablets, USP, 20-count box, Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895. Made in India. UPC 0 50428 43023 1
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1799-2019·2019-06-26

    Arrowg+ard Blue Advance JACC Recalled for Incorrect Expiration Date

    Arrow International Inc is recalling Arrowg+ard Blue Advance JACC products due to an incorrect expiration date listed by Lidstock.

    Product
    Arrowg+ard Blue Advance JACC Product Code: CDC 42041 JX1A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1840-2019·2019-06-26

    LEEP Precision Integrated System Recalled for Incorrect Fuse Installation

    CooperSurgical is recalling 19 LEEP Precision Integrated Systems because incorrect fuses may have been installed in the generator.

    Product
    LEEP Precision Integrated System 120V, Model LP-10-120 Product Usage: The LEEP PRECISION INTEGRATED SYSTEM l 20V combines three components - LEEP PRECISION Cart, LEEP PRECISION Generator, and the LEEP PRECISION Smoke Evacuator for loop electrosurgical excision procedures. The
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1805-2019·2019-06-26

    Arrow PICC with Chloraguard Technology Recalled for Incorrect Expiration Date

    Arrow International Inc. is recalling 135 units of Arrow PICC with Chloraguard Technology due to an incorrect expiration date.

    Product
    Arrow¿ PICC with Chlorag+ard Technology Product Code: CDC 44052 HPK1A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1800-2019·2019-06-26

    Arrowg+ard Blue Advance JACC recalled for incorrect expiration date

    Arrow International Inc is recalling 84 units of Arrowg+ard Blue Advance JACC due to incorrect expiration dates.

    Product
    Arrowg+ard Blue Advance JACC Product Code:CDC 42052 JX1A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1801-2019·2019-06-26

    Arrowg+ard Blue Advance JACC Recalled for Incorrect Expiration Date

    Arrow International Inc is recalling Arrowg+ard Blue Advance JACC products due to an incorrect expiration date. The recall involves 174 units distributed nationwide.

    Product
    Arrowg+ard Blue Advance JACC Product Code: CDC 42063 JX1A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1793-2019·2019-06-26

    Arrow PICC Recall Due to Incorrect Expiration Date Labeling

    Arrow International Inc is recalling 108 units of Arrow PICC with Chloraguard Technology because the product was labeled with an incorrect expiration date.

    Product
    Arrow PICC with Chlorag+ard Technology Product Code: CDA 45041 HPK1A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1389-2019·2019-06-26

    Sun Pharmaceutical Recalls Wal-Fex D Tablets Due to Impurity Testing Failures

    Sun Pharmaceutical is recalling Wal-Fex D tablets because testing showed impurity levels above or near specification limits.

    Product
    Wal-Fex D Fexofenadine HCl 60 mg/ Pseudoephedrine HCl 120 mg/ Extended-Release Tablets, USP, Allergy & Congestion, 30-count box. Distributed by: Walgreen Co. 200 Wilmore Rd. Deerfield, IL 40015. Made in India. UPC 3 11917 19454 7
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1447-2019·2019-06-26

    Zydus Recalls Pramipexole Dihydrochloride Tablets Due to Cross-Contamination

    Zydus Pharmaceuticals is recalling Pramipexole Dihydrochloride Tablets 1 mg due to cross-contamination caused by a cleaning failure.

    Product
    Pramipexole Dihydrochloride Tablets 1 mg, 90-count bottle, Rx only, Manufactured by: Cadila Healthcare Ltd Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534. NDC 68382-199-16
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1812-2019·2019-06-26

    Arrow JACC Medical Device Recalled for Incorrect Expiration Date Labeling

    Arrow International Inc is recalling 2 units of Arrow JACC with Chloraguard Technology due to an incorrect expiration date on the product label.

    Product
    Arrow¿ JACC with Chlorag+ard Technology Product Code: JR 42041 HPHNM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1795-2019·2019-06-26

    Arrow PICC Recall Issued for Incorrect Expiration Date Labeling

    Arrow International Inc is recalling 20 units of Arrow PICC with Chlorag+ard Technology due to an incorrect expiration date on the label.

    Product
    Arrow PICC with Chlorag+ard Technology Product Code: CDA 45541 HPK1A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1824-2019·2019-06-26

    Mako Surgical Recalls 2.7 Degree Straight Sagittal Saw Attachments

    Mako Surgical Corporation is recalling 2.7 Degree Straight Sagittal Saw attachments because the bearings were ungreased. The devices were distributed to facilities in 13 US states and three international countries.

    Product
    2.7 Degree Straight Sagittal Saw attachment (Mako Total Knee Application and Partial Knee Application 3.0)
    Category
    Medical Device
    Distribution
    13 states
  • ModerateFDA (Devices)·Z-1849-2019·2019-06-26

    Stryker Endotrac Hook/Triangle Blade Kit Recall Due to Seal Integrity

    Stryker GmbH is recalling 1,600 Endotrac EPF/EGR Hook/Triangle Blade Kits because the sterile bag seal integrity may be compromised.

    Product
    Endotrac EPF/EGR Hook/Triangle Blade Kit, Catalogue Number 3056-1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1808-2019·2019-06-26

    Arrow International Recalls PICC Catheters Due to Incorrect Expiration Date

    Arrow International Inc is recalling Arrowg+ard Blue Advance PICC catheters because the product has an incorrect expiration date.

    Product
    Arrowg+ard Blue Advance" PICC pre loaded with Arrow¿ VPS" Precision Stylet Product Code: CDC 45041 VPS2
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1821-2019·2019-06-26

    Arrow PICC with Chloraguard Technology Recalled for Incorrect Expiration Date

    Arrow International Inc is recalling 578 units of Arrow PICC with Chloraguard Technology due to an incorrect expiration date.

    Product
    Arrow¿ PICC with Chlorag+ard¿ Technology Product Code: PR 45552 HPHNL
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1850-2019·2019-06-26

    Arkray AUTION HYBRID AU-4050 Recalled for Software Error

    Arkray Factory USA, Inc. is recalling 159 AUTION HYBRID AU-4050 units due to a software issue that could assign incorrect patient information to sample results.

    Product
    AUTION HYBRID AU-4050
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-1449-2019·2019-06-26

    Zydus Recalls Methylprednisolone Tablets Due to Cross-Contamination

    Zydus Pharmaceuticals is recalling Methylprednisolone tablets due to cross-contamination caused by cleaning failures. The affected lots are distributed nationwide.

    Product
    METHYLPREDNISOLONE — METHYLPREDNISOLONE (METHYLPREDNISOLONE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1387-2019·2019-06-26

    Sun Pharmaceutical Recalls Allergy Relief D Tablets Due to Impurities

    Sun Pharmaceutical is recalling Allergy Relief D tablets because testing showed impurities and degradation levels above or near specification limits.

    Product
    Allergy Relief D, Fexofenadine HCl 60 mg/ Pseudoephedrine HCl 120 mg, Extended Release Tablets, USP, 30-count box, Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895. Made in India. UPC 0 50428 39131 0
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1788-2019·2019-06-26

    Arrow PICC Kit Recalled for Incorrect Expiration Date Labeling

    Arrow International Inc. is recalling 105 units of Arrow PICC Kits due to incorrect expiration dates on the packaging.

    Product
    Arrow¿ PICC Kit Product Code: ASK 45541 LVH1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1811-2019·2019-06-26

    Arrowg+ard Blue Advance PICC Recalled for Incorrect Expiration Date

    Arrow International Inc is recalling 450 units of Arrowg+ard Blue Advance PICC devices due to incorrect expiration dates.

    Product
    Arrowg+ard Blue Advance PICC Product Code: CDC45541HPK1A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1453-2019·2019-06-26

    Zydus Recalls Methylprednisolone Tablets Due to Cross-Contamination

    Zydus Pharmaceuticals is recalling specific lots of Methylprednisolone tablets due to cross-contamination caused by cleaning failures.

    Product
    METHYLPREDNISOLONE — METHYLPREDNISOLONE (METHYLPREDNISOLONE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1818-2019·2019-06-26

    Arrowg+ard Blue Advance Midline Recalled for Incorrect Expiration Date

    Arrow International Inc is recalling Arrowg+ard Blue Advance Midline devices due to an incorrect expiration date printed on the product.

    Product
    Arrowg+ard Blue Advance Midline Product Code: PR 41541 BAS
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1798-2019·2019-06-26

    Arrowg+ard Blue Advance JACC Recalled for Incorrect Expiration Date

    Arrow International Inc. is recalling 77 units of Arrowg+ard Blue Advance JACC products because they were labeled with an incorrect expiration date.

    Product
    Arrowg+ard Blue Advance JACC Product Code: CDC 41552 JX1A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1765-2019·2019-06-26

    Teleflex Recalls Sheridan/CF Novaplus Tracheal Tubes Due to Connector Issues

    Teleflex Medical is voluntarily recalling specific lots of Sheridan/CF Novaplus 7.0 mm tracheal tubes because the 15 mm Sheridan connector may disconnect from the tube.

    Product
    Sheridan/CF Novaplus 7.0 mm, Product Code V5-10114 Product Usage: Tracheal tube/airway management
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1813-2019·2019-06-26

    Arrow JACC Medical Device Recalled for Incorrect Expiration Date Labeling

    Arrow International Inc. is recalling 9 units of Arrow JACC with Chloraguard Technology due to incorrect expiration dates on the product.

    Product
    Arrow¿ JACC with Chlorag+ard Technology Product Code: JR 42063 HPHNM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1797-2019·2019-06-26

    Arrowg+ard Blue Advance JACC Recalled for Incorrect Expiration Date

    Arrow International Inc is recalling 78 units of Arrowg+ard Blue Advance JACC due to incorrect expiration dates. The recall is nationwide.

    Product
    Arrowg+ard Blue Advance JACC Product Code: CDC 41541 JX1A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1820-2019·2019-06-26

    Arrow PICC Catheters Recalled for Incorrect Expiration Date Labeling

    Arrow International is recalling 991 units of Arrow PICC with Chloraguard Technology due to incorrect expiration dates on the product.

    Product
    Arrow¿ PICC with Chlorag+ard Technology Product Code:PR 45541 HPHNM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1822-2019·2019-06-26

    Arrow PICC with Chloraguard Technology Recalled for Incorrect Expiration Date

    Arrow International Inc. is recalling Arrow PICC with Chloraguard Technology due to an incorrect expiration date on the product.

    Product
    Arrow¿ PICC with Chlorag+ard¿ Technology Product Code:PR 45552 HPHNM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1787-2019·2019-06-26

    Arrow PICC Powered by Arrow VPS Stylet Recalled for Incorrect Expiration Date

    Arrow International Inc. is recalling 66 units of Arrow PICC powered by Arrow VPS Stylet because the product has an incorrect expiration date.

    Product
    Arrow PICC powered by Arrow VPS Stylet Product Code: ASK45041JHVA
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1764-2019·2019-06-26

    Teleflex Recalls Sheridan Tracheal Tubes Due to Connector Disconnection

    Teleflex Medical is voluntarily recalling specific lots of Hudson RCI Sheridan tracheal tubes because the 15 mm connector may disconnect from the tube.

    Product
    Hudson RCI Sheridan: 1) HVT 6.0 mm, Product Code 5-10312 2) HVT 6.5 mm, Product Code 5-10313 3) HVT 7.0 mm, Product Code 5-10314 4) HVT 7.5 mm, Product Code 5-10315 5) HVT 8.0 mm, Product Code 5-10316 6) HVT 8.5 mm, Product Code 5-10317 Product Usage: Tracheal tube/airw
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1791-2019·2019-06-26

    Arrow PICC Kit Recalled for Incorrect Expiration Date Labeling

    Arrow International Inc is recalling 1,840 units of Arrow PICC Kits because the product labels display an incorrect expiration date.

    Product
    Arrow PICC Kit Product Code: ASK 45552 RWJ4
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1809-2019·2019-06-26

    Arrow International Recalls PICC Catheters Due to Incorrect Expiration Date

    Arrow International is recalling 350 units of Arrowg+ard Blue Advance PICC catheters because the product labels display an incorrect expiration date.

    Product
    Arrowg+ard Blue Advance PICC pre loaded with Arrow¿ VPS" Precision Stylet Product Code: CDC 45063 HPK1A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1796-2019·2019-06-26

    Arrow PICC Catheters Recalled for Incorrect Expiration Date Labeling

    Arrow International is recalling 159 units of Arrow PICC catheters because the expiration date printed on the packaging is incorrect.

    Product
    Arrow PICC with Chlorag+ard Technology Product Code: CDA 45552 VPS2
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1794-2019·2019-06-26

    Arrow PICC Catheters Recalled for Incorrect Expiration Date Labeling

    Arrow International Inc is recalling 185 units of Arrow PICC with Chloraguard Technology due to incorrect expiration dates on the packaging.

    Product
    Arrow PICC with Chlorag+ard Technology Product Code: CDA 45052 HPK1A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1789-2019·2019-06-26

    Arrow PICC Kit Recalled for Incorrect Expiration Date Labeling

    Arrow International Inc is recalling 100 units of Arrow PICC Kits due to an incorrect expiration date printed on the product.

    Product
    Arrow PICC Kit Product Code: ASK 45541 RWJ4
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1823-2019·2019-06-26

    Mako Surgical Recalls 2.7 Degree Angled Sagittal Saw Attachments

    Mako Surgical Corporation is recalling 39 units of the 2.7 Degree Angled Sagittal Saw attachment because the bearings were ungreased.

    Product
    2.7 Degree Angled Sagittal Saw attachment (Mako Total Knee Application Only)
    Category
    Medical Device
    Distribution
    13 states
  • ModerateFDA (Devices)·Z-1785-2019·2019-06-26

    Randox Liquid Cardiac Control Recalled for Potential Concentration Decrease

    Randox Laboratories is recalling specific lots of Liquid Cardiac Control due to potential decreased NTproBNP concentration readings on Siemens Dimension EXL LOCI analyzers.

    Product
    Liquid Cardiac Control, Model Nos. CQ5051, CQ5052, CQ5053
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-1806-2019·2019-06-26

    Arrow PICC Catheter Recalled for Incorrect Expiration Date Labeling

    Arrow International Inc. is recalling 162 units of Arrowg+ard Blue Advance PICC catheters due to an incorrect expiration date printed on the product.

    Product
    Arrowg+ard Blue Advance PICC pre loaded with Arrow¿ VPS" Precision Stylet Product Code: CDC 44052 VPS2
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1803-2019·2019-06-26

    Arrow JACC Central Catheter Recalled for Incorrect Expiration Date

    Arrow International Inc is recalling 191 units of JACC central catheters because the expiration date printed on the product is incorrect.

    Product
    Arrow¿ JACC with Chlorag+ard¿ Technology Jugular Axillo subclavian Central Catheter Product Code: CDC 42563 JX1A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1810-2019·2019-06-26

    Arrow International Recalls PICC Catheters Due to Incorrect Expiration Date

    Arrow International Inc is recalling 279 units of Arrowg+ard Blue Advance PICC catheters because the products display an incorrect expiration date.

    Product
    Arrowg+ard Blue Advance PICC pre loaded with Arrow¿ VPS" Precision Stylet Product Code: CDC 45063 VPS2
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1445-2019·2019-06-26

    Zydus Recalls Pramipexole Dihydrochloride Tablets Due to Cross Contamination

    Zydus Pharmaceuticals USA Inc is recalling Pramipexole Dihydrochloride Tablets 0.25 mg due to cross contamination caused by a cleaning failure.

    Product
    Pramipexole Dihydrochloride Tablets 0.25 mg, 1000-count bottle, Rx only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India. NDC 68382-197-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1390-2019·2019-06-26

    Sun Pharmaceutical Recalls Wal-Fex D Tablets Due to Impurity Testing Failures

    Sun Pharmaceutical is recalling Wal-Fex D allergy and congestion tablets because testing showed impurity levels above or near specification limits.

    Product
    Wal-Fex D Fexofenadine HCl 60 mg/ Pseudoephedrine HCl 120 mg, Extended-Release Tablets, USP, Allergy & Congestion, 20-count box.Distributed by: Walgreen Co. 200 Wilmore Rd. Deerfield, IL 40015. Made in India UPC 3 11917 19453 0
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1444-2019·2019-06-26

    Zydus Recalls Pramipexole Dihydrochloride Tablets Due to Cross-Contamination

    Zydus Pharmaceuticals is recalling Pramipexole Dihydrochloride Tablets 0.25 mg due to cross-contamination caused by cleaning failures.

    Product
    Pramipexole Dihydrochoride Tablets 0.25 mg, 90-count bottle, Rx Only, Manufactured by: Cadila Healthcare Ltd Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534. NDC 68382-197-16
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1792-2019·2019-06-26

    Arrow PICC Recall Due to Incorrect Expiration Date Labeling

    Arrow International Inc is recalling 180 units of Arrow PICC with Chlorag+ard Technology because the products bear an incorrect expiration date.

    Product
    Arrow PICC with Chlorag+ard Technology Product Code: CDA 44052 HPK1A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1790-2019·2019-06-26

    Arrow PICC Kit Recall Issued for Incorrect Expiration Date Labeling

    Arrow International Inc. is recalling 190 units of Arrow PICC Kits due to incorrect expiration dates printed on the product.

    Product
    Arrow PICC Kit pre loaded with Arrow¿ VPS Precision Stylet Product Code: ASK 45552 CRM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1817-2019·2019-06-26

    Arrowg+ard Blue Advance JACC Recalled for Incorrect Expiration Date

    Arrow International Inc. is recalling 52 units of Arrowg+ard Blue Advance JACC products due to an incorrect expiration date.

    Product
    Arrowg+ard Blue Advance JACC Product Code: JRT 43552 HPHNM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1392-2019·2019-06-26

    Akorn Recalls Myorisan Isotretinoin Capsules Due to Labeling Error

    Akorn Inc. is recalling 16,216 cartons of Myorisan isotretinoin capsules because secondary cartons incorrectly state 40 mg instead of 30 mg.

    Product
    Myorisan (isotretinoin capsules, USP), 40 mg, packaged in cartons of 30 Capsules containing 3 x 10 Prescription Packs, Rx Only, Distributed by: VersaPharm Inc. - An Akorn Company, Lake Forest, IL 60045, NDC 61748-304-13
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1391-2019·2019-06-26

    Teligent Pharma Recalls Betamethasone Dipropionate Ointment Due to Impurities

    Teligent Pharma is recalling Betamethasone Dipropionate Ointment 0.05% due to failed impurities and degradation specifications.

    Product
    Betamethasone Dipropionate Ointment USP, 0.05%* (Augmented), a) 15 gram (NDC 52565-019-15) and b) 50 gram (NDC 52565-019-51) tubed, Rx Only, Manufactured by: Teligent Pharma, Inc. Buena, New Jersey 06310
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1804-2019·2019-06-26

    Arrow JACC Central Catheter Recalled for Incorrect Expiration Date

    Arrow International Inc. is recalling 12 units of JACC central catheters because the expiration date printed on the packaging is incorrect.

    Product
    Arrow¿ JACC with Chlorag+ard¿ Technology Jugular Axillosubclavian Central Catheter Product Code: CDC 43063 JX1A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1843-2019·2019-06-26

    Cytocell Aquarius D13S319 Probe Recalled for Package Insert Error

    Cytocell Ltd. is recalling Aquarius D13S319 Plus Deletion Probes because the chromomap on the package insert contains an error.

    Product
    Aquarius D13S319 Plus Deletion Probe, Model LPH068-A Product Usage: The D13S319 probe, labelled in red, covers a 156kb region including most of the DLEU2 gene, part of the DLEU1 gene and the D13S319 and D13S272 markers. The 13qter subtelomere specific probe, labelled in green
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1815-2019·2019-06-26

    Arrow JACC Medical Device Recalled for Incorrect Expiration Date

    Arrow International Inc. is recalling 3 units of Arrow JACC with Chloragard Technology due to an incorrect expiration date.

    Product
    Arrow¿ JACC with Chlorag+ard Technology Product Code:JR 42563 HPHNM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1802-2019·2019-06-26

    Arrow JACC Central Catheter Recalled for Incorrect Expiration Date

    Arrow International Inc. is recalling 6 units of Arrow JACC Central Catheters because the expiration date is incorrect.

    Product
    Arrow JACC with Chlorag+ard Technology Jugular Axillo subclavian Central Catheter Product Code: CDC 42552 JX1A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V489000·2019-06-25

    Mercedes-Benz Metris Recalled for Potential Loss of Power Steering

    Daimler Vans USA is recalling 2018-2019 Mercedes-Benz Metris vehicles because a steering sensor defect may cause the electric power steering assist to deactivate, increasing crash risk.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ METRIS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·19146·2019-06-25

    West Marine Recalls Folding Deck Chairs Due to Fall and Injury Hazards

    West Marine is recalling about 11,600 folding deck chairs because a lock nut can loosen, posing fall and injury hazards. No injuries have been reported.

    Product
    West Marine Deck chairs and Comfort Plus Deck Crew folding chairs
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·19145·2019-06-25

    QTOP USA Recalls LED Work Light Bulbs Due to Fire Hazard

    QTOP USA is recalling specific LED work light replacement bulbs because they can overheat and cause fires. Consumers should stop using the bulbs and contact the company for a refund.

    Product
    LED Work Light Replacement Bulbs
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V488000·2019-06-24

    Mazda Recalls 2010-2011 RX-8 Vehicles for Air Bag Inflator Defect

    Mazda is recalling 2010-2011 RX-8 vehicles because the passenger air bag inflator may explode during deployment, potentially causing serious injury or death.

    Product
    MAZDA — MAZDA RX-8
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·071-2019·2019-06-24

    San Giuseppe Salami Recalls Frozen Andouille Sausage Due to Metal Contamination

    San Giuseppe Salami Co. by Giacomo is recalling approximately 832 pounds of frozen andouille sausage due to possible metal contamination. No illnesses have been reported.

    Product
    San Guiseppe Salami Co. by Giacomo — San Giuseppe Salami Co. by Giacomo Recalls Ready-To-Eat, Frozen Andouille Sausage Products due to Possible Foreign Matter Contamination
    Category
    Food
    Distribution
    1 state
  • SevereNHTSA·19V483000·2019-06-21

    Altec Aerial Devices Recalled for Air Brake System Defects

    Altec is recalling 2003-2019 aerial devices due to potential air brake pressure loss. Owners should contact dealers for free inspection and repair.

    Product
    ALTEC — ALTEC AERIAL DEVICE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V485000·2019-06-21

    Oshkosh Recalls 2019 McNeilus Front Loader Trucks Due to Fire Risk

    Oshkosh is recalling 2019 McNeilus Meridian, Atlantic, and Contender front loader trucks because battery cables may rub against the fuse box bracket, increasing the risk of fire.

    Product
    MCNEILUS — MCNEILUS MERIDIAN FRONT LOADER, ATLANTIC FRONT LOADER, CONTENDER FRONT LOADER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V484000·2019-06-21

    Oshkosh Recalls 2018 McNeilus Concrete Mixers for Tank Rupture Risk

    Oshkosh is recalling 2018 McNeilus Bridgemaster V Concrete Mixers because an incorrect filler neck part may cause the tank to overpressurize and rupture.

    Product
    MCNEILUS — MCNEILUS BRIDGEMASTER V MIXER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V486000·2019-06-21

    Oshkosh Recalls 2018-2019 S-Series Mixers Due to Steering Hose Error

    Oshkosh is recalling 2018-2019 S-Series Mixer vehicles because hydraulic hoses may be installed incorrectly, causing loss of steering assist and increasing crash risk.

    Product
    OSHKOSH — OSHKOSH S-SERIES
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·19V478000·2019-06-21

    Navistar Recalls 2011 IC Bus School Buses for Seat Belt Defect

    Navistar is recalling 2011 IC Bus RE, CE, and BE school buses because plastic parts on non-retractable seat belt buckles may crack, making them difficult to fasten.

    Product
    IC BUS — IC BUS RE, CE, BE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·19141·2019-06-21

    Honeywell Recalls Photoelectric Smoke Sensors for Fire Alarm Failure

    Honeywell is recalling about 22,000 photoelectric smoke sensors sold with fire alarm systems because they may fail to alert occupants of a fire.

    Product
    "-IV" Intelligent photoelectric smoke sensors sold with fire alarm systems
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·19V476000·2019-06-21

    Forest River Recalls 2017-2020 Recreational Trailers for Electrical Safety

    Forest River is recalling 2017-2020 Shasta and Coachmen recreational trailers because exterior kitchen outlets may lack GFCI protection, posing an electrical shock risk.

    Product
    SHASTA — SHASTA, COACHMEN PHOENIX, CHAPARRAL X-LITE, CHAPARRAL LITE, CHAPARRAL
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·19V487000·2019-06-21

    Charles Machine Recalls Ditch Witch Trailers Due to Brake Terminal Defect

    Charles Machine is recalling 2018-2019 Ditch Witch trailers because improperly crimped brake wire terminals may cause the brakes to fail, increasing crash risk.

    Product
    CHARLES MACHINE — CHARLES MACHINE DITCH WITCH
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·19V481000·2019-06-21

    Forest River Recalls 2019-2020 Motorhomes Due to Slide-Out Defect

    Forest River is recalling 2019-2020 Georgetown and FR3 motorhomes because slide-out mechanisms may activate unintentionally, increasing injury risk.

    Product
    FOREST RIVER — FOREST RIVER GEORGETOWN, FR3
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·19140·2019-06-21

    H.E. Industrial Recalls Electric Garage Heaters Due to Fire Hazard

    H.E. Industrial is recalling Profusion Heat electric garage heaters because the heating element can overheat, posing a fire hazard. No injuries have been reported in the United States.

    Product
    Electric garage heaters
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereNHTSA·19E043000·2019-06-20

    TRW Air Bag Electronic Control Units Recalled for Malfunction Risk

    TRW is recalling air bag electronic control units that may malfunction, potentially disabling or unexpectedly deploying air bags and seat belt pretensioners.

    Product
    AIR BAGS: AIR BAG/RESTRAINT CONTROL MODULE recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·19139·2019-06-20

    Hunter Brunswick Ceiling Fans Recalled Due to Electric Shock Hazard

    Hunter Fan Company is recalling Brunswick ceiling fans because damaged light kit wires pose an electric shock hazard. No injuries have been reported.

    Product
    Hunter Brunswick three and four light ceiling fans
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighUSDA FSIS·070-2019·2019-06-20

    C&S Wholesale Grocers Recalls Meat and Poultry Due to Temperature Abuse

    C&S Wholesale Grocers is recalling meat and poultry products sold at two New York Target stores due to possible temperature abuse during transport.

    Product
    C&S Wholesale Grocers Recalls Meat and Poultry Products due to Possible Temperature Abuse During Transport at Two Stores in New York
    Category
    Food
    Distribution
    1 state
  • CriticalFDA (Drugs)·D-1344-2019·2019-06-19

    Aphrodisiac Platinum 40000 Recalled for Unapproved Sildenafil Contamination

    Select Distributions LLC is recalling Aphrodisiac Platinum 40000 because FDA analysis found the product is tainted with sildenafil and was marketed without an approved NDA/ANDA.

    Product
    Aphrodisiac Platinum 40000, Proprietary Raw Material 6000 mg, 1 count blister card, 24 cards per box, Distributed by: APhrodisiac. UPC Code 644118128135
    Category
    Drug
    Distribution
    2 states
  • CriticalFDA (Drugs)·D-1398-2019·2019-06-19

    Heritage Pharmaceuticals Recalls Amikacin Sulfate Injection Due to Microbial Growth

    Heritage Pharmaceuticals is recalling Amikacin Sulfate Injection vials because microbial growth was detected in a sub-lot. The affected product is distributed nationwide in the USA.

    Product
    AMIKACIN SULFATE — AMIKACIN SULFATE (AMIKACIN SULFATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1334-2019·2019-06-19

    Pharm D Solutions Recalls Sermorelin/GHRP-2 &6 Vials for Sterility Concerns

    Pharm D Solutions, LLC is recalling Sermorelin/GHRP-2 &6 vials due to a lack of sterility assurance. The recall affects products distributed nationwide in the United States.

    Product
    Sermorelin/GHRP-2 &6 (9-9-9-mg) vials, Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844-263-6846
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1347-2019·2019-06-19

    Torrent Pharma Recalls Allergy Liquid Antihistamine Due to Bacterial Contamination

    Torrent Pharma Inc. is recalling 118,080 bottles of Allergy Liquid Antihistamine due to potential contamination with Burkholderia cepacia and Ralstonia pickettii.

    Product
    Allergy Liquid Antihistamine, Diphenhydramine HCl USP 12.5 mg/5 mL), Alcohol free, 4 FL. oz. (118 mL) bottle, NDC: 59741-119-06, Manufactured by Bio-Pharm Inc., Levittown, PA 19057, Assured.
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-1376-2019·2019-06-19

    Torrent Pharma Recalls Hydrocortisone Acetate Suppositories Due to Contamination Risk

    Torrent Pharma Inc. is recalling Hydrocortisone Acetate Suppositories due to potential contamination with Burkholderia cepacia and Ralstonia pickettii.

    Product
    Hydrocortisone Acetate Suppositories, 25 mg, Rx Only, For rectal administration, a) 12 Adult Suppositories per carton, NDC: 59741-301-12, b) 24 Adult Suppositories per carton, NDC: 59741-301-24, Manufactured by Bio-Pharm Inc., Levittown PA 19057.
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-1384-2019·2019-06-19

    Torrent Pharma Recalls Hydrocodone and Homatropine Oral Solution Due to Contamination

    Torrent Pharma Inc. is recalling specific lots of Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution due to potential contamination with Burkholderia cepacia and Ralstonia pickettii.

    Product
    Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution, 5 mg/1.5 mg per 5 mL, Rx Only, 16 FL. oz. (473 mL) bottle, NDC:13668-577-10 Distributed by Torrent Pharma Inc., Basking Ridge, NJ 07920.
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-1381-2019·2019-06-19

    Torrent Pharma Recalls Cetirizine Hydrochloride Oral Solution Due to Contamination

    Torrent Pharma Inc. is recalling specific lots of Cetirizine Hydrochloride Oral Solution due to potential contamination with Burkholderia cepacia and Ralstonia pickettii.

    Product
    Cetirizine Hydrochloride Oral Solution, USP 1mg/mL, Fr Oral Use Only, Rx only, 120 mL bottle, a) NDC 13668-029-07, b) NDC 13668-596-07, Manufactured by Bio-Pharm, Inc. Levittown, PA, For Torrent Pharma Inc., Basking Ridge, NJ 07920..
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-1333-2019·2019-06-19

    Pharm D Solutions Recalls Sermorelin Vials Due to Sterility Concerns

    Pharm D Solutions is recalling 100 vials of Sermorelin/GHRP-2 & 6 due to a lack of sterility assurance. The products were distributed nationwide in the United States.

    Product
    Sermorelin/GHRP-2 & 6 (3-3-3 MG) vials, Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844-263-6846
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1323-2019·2019-06-19

    Pharm D Solutions Recalls B-Complex Injectable Vials Due to Sterility Concerns

    Pharm D Solutions, LLC is recalling specific lots of B-complex injectable vials due to a lack of sterility assurance. The affected product is distributed nationwide.

    Product
    B-complex (Thiamine 100mg, Riboflavin 2mg, Niacinamide 100 mg, Pyridoxine 2mg, Depanthenol 5mg) injectable, 10 mL vials, Rx only, Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844-263-6846, NDC 69699-1611-30
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1371-2019·2019-06-19

    Torrent Pharma Recalls Nasal Decongestant Liquid Due to Bacterial Contamination

    Torrent Pharma Inc is recalling specific lots of Nasal Decongestant Liquid due to potential contamination with Burkholderia cepacia and Ralstonia pickettii.

    Product
    Nasal Decongestant Liquid, Pseudoephedrine HCl, 30 mg in each teaspoonful, 4 Fl. oz. (118 mL) bottle, NDC:0536-1850-97, Distributed by Rugby Laboratories, Livonia MI 48152.
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-1370-2019·2019-06-19

    Torrent Pharma Recalls Diphenhydramine Oral Solution Due to Bacterial Contamination

    Torrent Pharma Inc is recalling Diphenhist Oral Solution due to potential contamination with Burkholderia cepacia and Ralstonia pickettii.

    Product
    Diphenhist Oral Solution (Diphenhydramine HCl, USP), 12.5 mg/5 mL, a) 4 FL. oz. (118 mL) bottle, NDC: 0536-0770-97, b) One Pint (473 mL) bottle., NDC: 0536-0770-85, Distributed by Rugby Laboratories, Livonia, MI 48152.
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-1403-2019·2019-06-19

    Synthetopes Recalls Sn-d, l-Exametazime Due to Lack of Processing Controls

    Synthetopes Inc is recalling Sn-d, l-Exametazime vials nationwide due to a lack of processing controls. The FDA classifies this as a Class II recall.

    Product
    Sn-d, l-Exametazime (Sn-d,l-HMPAO), Not for Direct Injection, Store Below 25 C, Synthetopes, Inc.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1374-2019·2019-06-19

    Torrent Pharma Recalls Memantine Hydrochloride Oral Solution Due to Contamination

    Torrent Pharma Inc is recalling 5,681 bottles of Memantine Hydrochloride Oral Solution due to potential contamination with Burkholderia cepacia and Ralstonia pickettii.

    Product
    Memantine Hydrochloride Oral Solution, 2 mg/mL, 12 oz. bottle, NDC: 39328-551-12, Patrin Pharma
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-1362-2019·2019-06-19

    Torrent Pharma Recalls Acetic Acid Otic Solution Due to Bacterial Contamination

    Torrent Pharma is recalling specific lots of Acetic Acid Otic Solution due to potential contamination with Burkholderia cepacia and Ralstonia pickettii.

    Product
    Acetic Acid Otic Solution, USP, 2%, Rx Only, 15 mL bottle, NDC: 64980-424-15, Manufactured by Bio-Pharm Inc., Levittown, PA 19057, Distributed by Rising Pharmaceuticals Ins Saddie Brook, NJ 07663.
    Category
    Drug
    Distribution
    0 states

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