Pharma Rep Focus

Pfizer's Hospira recall spree bleeds into 2024 with product pulls for multiple hospital drugs in shortage

Fierce Pharma

DECEMBER 27, 2023

After a year plagued by recalls, Pfizer’s sterile injectables unit Hospira seems no closer to righting the ship over its glass-contamination woes. After a year plagued by recalls, Pfizer’s sterile injectables unit Hospira seems no closer to righting the ship over its glass-contamination woes.

Generics maker VistaPharm recalls ulcer med on bacteria contamination fears

Fierce Pharma

SEPTEMBER 25, 2023

Drugs tainted with impurities ranging from bacteria and particulates to likely cancer agents have triggered multiple FDA recalls in recent years. Drugs tainted with impurities ranging from bacteria and particulates to likely cancer agents have triggered multiple FDA recalls in recent years.

FDA

GSK amends commercial deal with Scynexis as antifungal recall drags into 2024

Fierce Pharma

JANUARY 3, 2024

When GSK laid out $90 million upfront to acquire rights to Scynexis’ antifungal Brexafemme last spring, the British pharma threw a lifeline to a company whose blockbuster launch ambitions had hit t | GSK has downgraded a licensing deal for Scynexis' antifungal ibrexafungerp following an ongoing recall of the drug's approved form, Brexafemme. (..)

Pharma

Specialty injectables maker Exela issues recall after particles turn up in 3 different drugs

Fierce Pharma

OCTOBER 27, 2023

Rogue particles turning up in drugs has caused a plethora of recalls in recent years, most recently affecting pharma giants Pfizer and GSK.

FDA

FDA Pharma Medical

Delaware's Marlex Pharmaceuticals recalls 2 batches of heart failure drug after labeling mix-up

Fierce Pharma

SEPTEMBER 1, 2023

Marlex Pharmaceuticals of New Castle, Delaware, is recalling two lots of digoxin tablets at the 0.125-mg and 0.25-mg When it comes to heart failure medication, a labeling mix-up can have dire consequences. mg dose, and vice versa.

Pharmaceutical

Pharmaceutical Medical

FDA Announces Recall of Heart Pumps Linked to Deaths and Injuries

MedCity News

APRIL 17, 2024

The recall comes years after surgeons say they first noticed problems with the HeartMate II and HeartMate 3, manufactured by Thoratec Corp., The post FDA Announces Recall of Heart Pumps Linked to Deaths and Injuries appeared first on MedCity News. a subsidiary of Abbott Laboratories.

FDA

FDA Manufacturing Marketing Physicians

After shutting down, Akorn recalls its 70-plus products nationwide

Fierce Pharma

APRIL 26, 2023

After shutting down, Akorn recalls its 70-plus products nationwide zbecker Wed, 04/26/2023 - 16:06

Particulates, label issues prompt separate recalls for Pfizer's Hospira and Accord

Fierce Pharma

JANUARY 4, 2023

Particulates, label issues prompt separate recalls for Pfizer's Hospira and Accord. Wed, 01/04/2023 - 11:35.

It’s Time to Make Effective Alternatives a Bigger Part of the CPAP Recall Story

MedCity News

JULY 14, 2023

For those unfamiliar with the CPAP recall situation in question, imagine if one-third of all cars on the road were suddenly recalled for potentially life-threatening issues.

Media

Media Medical

Sun Pharma initiates recall of Febuxostat for gout in US

Pharmaceutical Technology

MARCH 11, 2024

Sun Pharma has announced a recall of 55,000 bottles of Febuxostat, a medication used to treat gout, from the US market

Pharma

Pharma Medical Marketing

TraceLink Introduces Digital Recalls Solution

Pharmaceutical Commerce

NOVEMBER 10, 2023

New E2E workflow orchestration service is expected to simplify the processes of health systems and retail pharmacies while also reducing the risk of recalled items reaching patients.

Retail

Retail Patients

Azurity Recalls Zenzedi

PharmaTech

JANUARY 29, 2024

The company issued the recall because of a package mislabeling problem.

UK recall of Clinigen’s Mexiletine hydrochloride hard capsules

European Pharmaceutical Review

AUGUST 5, 2022

Clinigen Healthcare is recalling three batches of Mexiletine hydrochloride hard capsules, indicated for the treatment of documented arrhythmias, due to a potential risk of under- or overdose, which could have consequences for the safety of patients. For contact numbers and further information, please visit the MHRA recall notice.

Distribution

Distribution Healthcare Healthcare Medicine

Bayer pulls batch of cancer med Vitrakvi over bacterial contamination concerns

Fierce Pharma

NOVEMBER 20, 2023

The threat of microbial contamination has triggered yet another drug recall, this time from German pharma bigwig Bayer. Bayer is recalling one lot of Vitrakvi oral solution in the U.S. after routine stability testing discovered the presence of microbial contamination identified as Penicillium brevicompactum.

Pharma

Par Pharmaceutical Recalls Treprostinil Injection 20 mg/20 mL (1 mg/mL)

PharmaTech

MARCH 22, 2024

The company is recalling one lot of the product because of the potential presence of silicone particulates.

Pharmaceutical

Another recall: does Philips have a quality control problem?

Pharmaceutical Technology

FEBRUARY 9, 2024

Philips' has recalled a number of high profile medical devices in recent years, shaking investor confidence.

Medical

Amneal Pharmaceuticals Recalls Vancomycin Hydrochloride for Oral Solution USP, 250 mg/5 mL

PharmaTech

MARCH 30, 2024

The company is voluntarily recalling the product for potential super potent bottles due to overfilling.

Pharmaceutical

Pfizer’s Hospira issues recall after glass particles found in injectables

Pharmaceutical Technology

OCTOBER 4, 2023

The voluntary recall issued by Hospira will affect three different injectables following the potential presence of glass particles.

Drug recalls are ticking upwards — here’s how to avoid costly pitfalls

PharmaVoice

SEPTEMBER 8, 2022

Supply chain challenges, labor shortages and increased FDA inspections are boosting recall risks — but careful planning can keep companies in the clear.

FDA

Novartis recalls Sandimmune oral solution over crystallisation issues

Pharmaceutical Technology

NOVEMBER 27, 2023

Novartis has announced a voluntary recall of two lots of its 100mg/mL Sandimmune Oral Solution over crystallisation issues.

Lupin recalls pregnancy prevention drug Tydemy

Pharmaceutical Technology

JULY 31, 2023

Lupin Pharmaceuticals has announced the voluntary recall of two lots of the pregnancy prevention drug Tydemy

Pharmaceutical

Novartis recalls Sandimmune oral solution due to crystal formation

Pharmaceutical Technology

SEPTEMBER 12, 2023

Novartis has announced a voluntary recall of one lot of Sandimmune Oral Solution in the US due to crystal formation observed in some bottles.

UK MHRA recalls batches of eye gels due to microbial contamination

Pharmaceutical Technology

NOVEMBER 27, 2023

The UK MHRA has issued a recall of batches of carbomer-containing lubricating eye gels due to potential microbial contamination.

InvaGen Pharmaceuticals Recalls Vigabatrin for Oral Solution, USP 500 mg

PharmaTech

DECEMBER 11, 2023

The product is being voluntarily recalled because of powder leakage due to seal integrity issues.

Pharmaceutical

Sucralfate Oral Suspension Recalled Due to Microbial Contamination

PharmaTech

SEPTEMBER 25, 2023

VistaPharm is recalling Sucralfate Oral Suspension, 1g/10mL because of Bacillus cereus contamination.

GSK yanks 2 batches of its asthma blockbuster Nucala in Taiwan over glass particle fears

Fierce Pharma

JULY 18, 2023

When those standards start to slip, recalls are sure to follow. | In tandem with Taiwan’s Food and Drug Administration, GSK this week initiated a recall of two batches of its severe asthma injection Nucala after glass fragments were found in a vial of the drug.

Food and Drug Administration

Food and Drug Administration Food

Voluntary Nationwide Recall of Brimonidine Tartrate Ophthalmic Solution, 0.15%

PharmaTech

MARCH 6, 2023

Any patients who have received the identified lots or have any questions regarding the recall should contact their pharmacy or immediately contact a health provider in terms of medical advice.

Medical

Medical Patients

Fierce Pharma Asia—Eisai's subcutaneous Leqembi study; Astellas' IRA lawsuit; and GSK's Taiwan recall

Fierce Pharma

JULY 20, 2023

After a recent study of Eisai's subcutaneous Leqembi formulation, the company is touting its "promising" results. Eisai showed off "promising" results from a modeling and bioavailability study of its subcutaneous Leqembi formulation.

Pharma

Novartis Voluntarily Recalls Two Lots of Sandimmune Oral Solution, 100 mg/mL

PharmaTech

DECEMBER 4, 2023

Novartis has issued a nationwide voluntary recall of two lots of Sandimmune Oral Solution (cyclosporine oral solution, USP), 100 mg/mL because of crystallization issues.

Leiters Health Recalls Vancomycin IV Bags, Phenylephrine IV Bags, and Fentanyl IV Bags

PharmaTech

JANUARY 9, 2024

The potential for superpotent drug initiated the voluntary recall.

Camber Pharmaceuticals Recalls Antifungal Drug Due to Contamination Risk

Pharma Leaders

APRIL 4, 2023

Camber Pharmaceuticals has recalled one lot of Atovaquone oral suspension, USP 750mg/5mL because of the possible contamination with Bacillus cereus — bacteria found in soil, plants and food.

Pharmaceutical

Pharmaceutical Distribution Food Medicine

Azurity Pharmaceuticals Recalls Zenzedi

Pharmaceutical Commerce

JANUARY 29, 2024

One lot of the company’s branded dextroamphetamine sulfate tablets is being removed from shelves nationwide due to a pharmacy receiving carbinoxamine maleate instead.

Pharmaceutical

Endo sues Zydus in attempt to block its generic version of Chantix

Fierce Pharma

AUGUST 11, 2023

Since Pfizer’s smoking cessation drug Chantix was recalled in 2021, Endo's subsidiary Par Pharmaceuticals has been the only one to market the product.

Pharmaceutical

Pharmaceutical Marketing

Contamination Risk Sparks a Recall of GSK, Scynexis Antifungal Drug

MedCity News

SEPTEMBER 25, 2023

Scynexis said no adverse events or contamination problems have been reported for Brexafemme, an antifungal approved for treating vaginal yeast infections. The biotech said the risk of cross-contamination stems from the processes of the small molecule’s third-party manufacturer.

Manufacturing

Manufacturing FDA Biopharma Pharma

Hospira Issues Voluntary Recall for One Lot of Propofol Injectable Emulsion, USP

PharmaTech

JULY 20, 2022

Hospira has issued a voluntary nationwide recall for one lot of Propofol Injectable Emulsion, USP (containing benzyl alcohol), due to the potential presence of visible particulate.

Teva’s AUSTEDO XR Campaign Featured in MM+M

Eversana Intouch

APRIL 4, 2024

So that brand recall is important. In terms of all of the kinds of tools that we have at our disposal, a jingle is one of the most powerful ways to create that stickiness and that brand recall.” “For pharma in general, it might be weeks or longer before you can even talk to your healthcare provider,” she says. “So

Side effects

Side effects Healthcare Provider Healthcare Healthcare

Philips Respironics Finalizes Consent Decree Regarding Business Operations in the US with Department of Justice, FDA

PharmExec

APRIL 10, 2024

Decree comes amid the FDA’s 2021 inspection of Philips’ Murrysville facility and the subsequent voluntary recall of its sleep and respiratory care devices.

FDA

FDA warns of reduced efficacy for oral birth control pill Tydemy

Pharmaceutical Technology

AUGUST 2, 2023

Two lots of Lupin’s Tydemy have been recalled due to a decrease in ascorbic acid levels leading to reduced effectiveness.

FDA

FDA Leads

Reflecting on five years of quality control for nitrosamine impurities

European Pharmaceutical Review

JUNE 29, 2023

Quality control testing can help manufacturers in monitoring their processes and reduce the risks of potential formation of those impurities, thus minimising disruptive and costly drug recalls. 2 Another ARB affected by the recall, losartan, was at the time, the ninth-most prescribed drug in the US.

Food and Drug Administration

Food and Drug Administration Manufacturing Food Medicine

A scientific approach to irrational consumer choices

World of DTC Marketing

DECEMBER 2, 2021

Presenting quantitative information increased participants’ gist and verbatim recall of drug efficacy. Higher numeracy was associated with better gist and verbatim recall.” Ad recall is essential for CPGs, but for prescription drugs, the question that’s missing is “what action did it lead to?

Food and Drug Administration

Food and Drug Administration Side effects FDA Prescription

Why small particles matter: Manufacturing and micro-material contamination

Pharmaceutical Technology

MARCH 6, 2024

To protect patient safety and reduce recall risks, drug manufacturers must reduce particle contamination sources wherever possible.

Manufacturing

Manufacturing Safety Patients

Preventing fungal contamination in pharmaceuticals

European Pharmaceutical Review

MARCH 11, 2024

elaborated, noting that based on recall data collected by the US Food and Drug Administration (FDA) in over 100 products between 2000–2010, “fungi existed in 21 percent of products.” The authors also shared: “in the last three years [since 2023], the US FDA has recalled several drugs due to fungal contamination.” Ahmed et al.

Pharmaceutical

Pharmaceutical Food and Drug Administration Manufacturing Pharmaceutical products

How hospitals can address medical device vulnerabilities

MedCity News

SEPTEMBER 5, 2022

But make no mistake: they are cyber assets, and often riddled with vulnerabilities and recalls. Historically, medical devices weren’t connected, and too often security is still an afterthought for manufacturers.

Medical

Medical Manufacturing

Childproof packaging: How things are changing for consumer drugs

Pharmaceutical Technology

NOVEMBER 9, 2023

New sustainable packaging technologies aimed at children and seniors need to be prioritised to avoid drug recalls.

Pfizer's Hospira recall spree bleeds into 2024 with product pulls for multiple hospital drugs in shortage

Generics maker VistaPharm recalls ulcer med on bacteria contamination fears

Trending Sources

GSK amends commercial deal with Scynexis as antifungal recall drags into 2024

Specialty injectables maker Exela issues recall after particles turn up in 3 different drugs

Delaware's Marlex Pharmaceuticals recalls 2 batches of heart failure drug after labeling mix-up

FDA Announces Recall of Heart Pumps Linked to Deaths and Injuries

After shutting down, Akorn recalls its 70-plus products nationwide

Particulates, label issues prompt separate recalls for Pfizer's Hospira and Accord

It’s Time to Make Effective Alternatives a Bigger Part of the CPAP Recall Story

Sun Pharma initiates recall of Febuxostat for gout in US

TraceLink Introduces Digital Recalls Solution

Azurity Recalls Zenzedi

UK recall of Clinigen’s Mexiletine hydrochloride hard capsules

Bayer pulls batch of cancer med Vitrakvi over bacterial contamination concerns

Par Pharmaceutical Recalls Treprostinil Injection 20 mg/20 mL (1 mg/mL)

Another recall: does Philips have a quality control problem?

Amneal Pharmaceuticals Recalls Vancomycin Hydrochloride for Oral Solution USP, 250 mg/5 mL

Pfizer’s Hospira issues recall after glass particles found in injectables

Drug recalls are ticking upwards — here’s how to avoid costly pitfalls

Novartis recalls Sandimmune oral solution over crystallisation issues

Lupin recalls pregnancy prevention drug Tydemy

Novartis recalls Sandimmune oral solution due to crystal formation

UK MHRA recalls batches of eye gels due to microbial contamination

InvaGen Pharmaceuticals Recalls Vigabatrin for Oral Solution, USP 500 mg

Sucralfate Oral Suspension Recalled Due to Microbial Contamination

GSK yanks 2 batches of its asthma blockbuster Nucala in Taiwan over glass particle fears

Voluntary Nationwide Recall of Brimonidine Tartrate Ophthalmic Solution, 0.15%

Fierce Pharma Asia—Eisai's subcutaneous Leqembi study; Astellas' IRA lawsuit; and GSK's Taiwan recall

Novartis Voluntarily Recalls Two Lots of Sandimmune Oral Solution, 100 mg/mL

Leiters Health Recalls Vancomycin IV Bags, Phenylephrine IV Bags, and Fentanyl IV Bags

Camber Pharmaceuticals Recalls Antifungal Drug Due to Contamination Risk

Azurity Pharmaceuticals Recalls Zenzedi

Endo sues Zydus in attempt to block its generic version of Chantix

Contamination Risk Sparks a Recall of GSK, Scynexis Antifungal Drug

Hospira Issues Voluntary Recall for One Lot of Propofol Injectable Emulsion, USP

Teva’s AUSTEDO XR Campaign Featured in MM+M

Philips Respironics Finalizes Consent Decree Regarding Business Operations in the US with Department of Justice, FDA

FDA warns of reduced efficacy for oral birth control pill Tydemy

Reflecting on five years of quality control for nitrosamine impurities

A scientific approach to irrational consumer choices

Why small particles matter: Manufacturing and micro-material contamination

Preventing fungal contamination in pharmaceuticals

How hospitals can address medical device vulnerabilities

Childproof packaging: How things are changing for consumer drugs

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