Author Archives: Editor

Gentamicin Sulfate Injection

Presentation

80 mg per 2 mL (40 mg per mL), MDV, (NDC 63323-010-02)

800 mg per 20 mL (40 mg per mL), MDV, (NDC 63323-010-20)

20 mg per 2 mL (10 mg per mL), Pediatric SDV, (NDC 63323-173-02)

Availability and Estimated Shortage Duration

Backordered. Next release May 2022.

Backordered. Next release May 2022.

Related Information

Check wholesaler inventory

Shortage Reason (per FDASIA)

Manufacturing delay

US-FDA Link: https://www.accessdata.fda.gov/scripts/drugshortages/dsp_ActiveIngredientDetails.cfm?AI=Gentamicin+Sulfate+Injection&st=c&tab=tabs-4&panels=1

Furosemide Injection

Presentation

20 mg/2mL vial (NDC 70860-302-41 and 70860-302-02)

40 mg/4mL vial (NDC 70860-302-42 and 70860-302-04)

100 mg/10mL vial (NDC 70860-302-43 and 70860-302-10)

Availability and Estimated Shortage Duration

Available

Related Information

Marketed by Athenex. To order, contact Athenex at 855-273-0154

Shortage Reason (per FDASIA)

US-FDA Link: https://www.accessdata.fda.gov/scripts/drugshortages/dsp_ActiveIngredientDetails.cfm?AI=Furosemide+Injection&st=c&tab=tabs-4&panels=1

Fentanyl Citrate (Sublimaze) Injection

Presentation:

2 mL ampule 10 pack (NDC 17478-0030-02)\

2 mL ampule; 25 pack (NDC 17478-0030-25)

5 mL ampule 10 pack (NDC 17478-0030-05)

20 mL ampule (NDC 17478-0030-20)

5 mL ampule 25 pack (NDC 17478-0030-55)

Availability and Estimated Shortage Duration

Available

Discontinued

Related Information

Shortage Reason (per FDASIA)

Other

 

Teva Initiates Voluntary Nationwide Recall of One Lot of Topotecan Injection 4 mg/4 mL (1 mg/mL) Due to Presence of Particulate Matter

Date: 07/01/2021

Product type: Drugs, Potential Foreign Material

Company Announcement Date: June 30, 2021
FDA Publish Date: July 01, 2021
Product Type: Drugs
Reason for Announcement: Presence of particulate matter
Company Name: Teva Pharmaceuticals
Brand Name: Teva
Product Description: Topotecan Injection 4 mg/4 mL (1 mg/mL)

US-FDA Link: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/teva-initiates-voluntary-nationwide-recall-one-lot-topotecan-injection-4-mg4-ml-1-mgml-due-presence

 

Ardil Comercial Issues Voluntary Nationwide Recall of Limar Hand Sanitizer Packaged in 4 oz Bottles Because They Resemble Drink Containers

Date:  07/01/2021

Product type: Drugs, Potential Packaging Issue

Company Announcement Date: July 01, 2021
FDA Publish Date: July 01, 2021
Product Type: Drugs
Reason for Announcement: Packaged in bottles that resemble drink containers
Company Name: Ardil Commercial
Brand Name: Limar
Product Description: Hand sanitizer

US-FDA Link: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/ardil-comercial-issues-voluntary-nationwide-recall-limar-hand-sanitizer-packaged-4-oz-bottles

Medtronic Vascular Recalls Angiographic Guidewire Component Due to Being Non-sterile

Date: 07/02/2021

Product type:  Medical Device

Recalled Product

  • Angiographic Guidewire Component
  • Model Numbers:
    • WIRE ANGIO 107042 PNS .035X145 3MMJ PTFE; Part No: 107042
    • WIRE ANGIO 107044 PNS .038X145 3MMJ PTFE; Part No: 107044
    • WIRE ANGIO 107447 PNS .035X145 3MMJ PTFE; Part No: 107447
    • WIRE ANGIO 110003 PNS .035C145 3MMJ PTFE; Part No: 110003
    • WIRE ANGIO 110004 PNS.038X145 3MMJ LTPTF; Part No: 110004
  • Distribution Dates: November 23, 2007 to March 29, 2021
  • Devices Recalled in the U.S.: 54,997
  • Date Initiated by Firm: May 4, 2021

US-FDA Link: https://www.fda.gov/medical-devices/medical-device-recalls/medtronic-vascular-recalls-angiographic-guidewire-component-due-being-non-sterile

Quidel Recalls Lyra SARS-CoV-2 Assay (M120) Due to Risk of False Negative Results

Date: 07/07/2021

Product type:  Medical Device

Recalled Product

  • Lyra SARS-CoV-2 Assay (M120)
  • Lot codes: 031620A, 031620B, 031620C, 032320, 032420, 032720, 032820A, 032820B, 040320, 040720, 040920, 041020, 174992, 175429, 175501, 175502, 175503, 176001, 176002, 176366, 176367, 176368, 178984, 178985, 180331, 180332, 180673, 180674, 180675, 182594, 184273, 185535, 185822, 186470, 186472, 187062, 187173, 187822, 189232, 189942, 190786, 193074, 193977
  • Manufacturing Dates: March 17, 2020 to March 12, 2021
  • Distribution Dates: March 17, 2020 to May 27, 2021
  • Devices Recalled in the U.S.: 18385 (each kit contains 96 reactions)
  • Date Initiated by Firm: April 26, 2021

US-FDA Link: https://www.fda.gov/medical-devices/medical-device-recalls/quidel-recalls-lyra-sars-cov-2-assay-m120-due-risk-false-negative-results

Innoveix Pharmaceuticals, Inc. Issues Voluntary Recall of All Sterile Compounded Drug Products Due to A Lack of Sterility Assurance

Date: 07/13/2021

Product type: Drugs, Potential Lack of Sterility

Company Announcement Date: July 12, 2021
FDA Publish Date: July 13, 2021
Product Type: Drugs
Reason for Announcement: Potential lack of sterility assurance
Company Name: Innoveix Pharmaceuticals, Inc.
Brand Name: Innoveix Pharmaceuticals, Inc.
Product Description: Injectable Semorelin / Ipamorelin 3mg and injectable AOD-9604 3mg

US-FDA Link: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/innoveix-pharmaceuticals-inc-issues-voluntary-recall-all-sterile-compounded-drug-products-due-lack-0

Johnson & Johnson Consumer Inc. Issues Voluntary Recall of Specific NEUTROGENA® and AVEENO® Aerosol Sunscreen Products Due to the Presence of Benzene

Date: 07/14/2021

Product type: Drugs, Potential Foreign Material

Company Announcement Date: July 14, 2021
FDA Publish Date: July 14, 2021
Product Type: Drugs
Reason for Announcement: Testing identified low levels of benzene
Company Name: Johnson & Johnson
Brand Name: Neutrogena, Aveeno
Product Description: Sunscreen

US-FDA Link: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/johnson-johnson-consumer-inc-issues-voluntary-recall-specific-neutrogenar-and-aveenor-aerosol