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Pfizer Accupril (Quinapril HCl) tablets - recalled due to Due to N-Nitroso-Quinapril, USA

1 month ago

United States

Pfizer is voluntarily recalling five (5) lots of Accupril (Quinapril HCl) tablets distributed by Pfizer to the patient (consumer/user) level due to the presence of a nitrosamine, Nnitroso-quinapril, observed in recent testing above the Acceptable Daily Intake (ADI) level.

Nitrosamines are common in water and foods, including cured and grilled meats, dairy products and vegetables. Everyone is exposed to some level of nitrosamines. These impurities may increase the risk of cancer if people are exposed to them above acceptable levels over long periods of time.i Accupril is indicated for the treatment of hypertension, to lower blood pressure. 

Accupril is also indicated in the management of heart failure as adjunctive therapy when added to conventional therapy including diuretics and/or digitalis. Accupril has a safety profile that has been established over 30 years. To date, Pfizer is not aware of reports of adverse events that have been assessed to be related to this recall. Pfizer believes the benefit/risk profile of the products remains positive based on currently available data. Although long-term ingestion of Nnitroso-quinapril may be associated with a potential increased cancer risk in humans, there is no immediate risk to patients taking this medication. Patients currently taking the products should consult with their doctor or health care provider about alternative treatment options for them.

The NDC, Lot Number, Expiration Date, and Configuration details for these products are indicated in the tables below and photos of the products can be found at the end of this press release. The product lots were distributed nationwide to wholesalers and distributors in the United States and Puerto Rico from December 2019 to April 2022. Accupril® (Quinapril HCl Tablets), 10 mgAccupril® (Quinapril HCl Tablets), 20 mgAccupril® (Quinapril HCl Tablets), 40 mg.

NDC: 0071-0530-23
Lot Number: DR9639
Expiration Date: 2023 MAR 31
Strength: 10 mg
Configuration/ Count: 1 x 90 count bottle

NDC: 0071-0532-23
Lot Number: DX8682
Expiration Date: 2023 MAR 31
Strength: 20 mg
Configuration/ Count: 1 x 90 count bottle

NDC: 0071-0532-23
Lot Number: DG1188
Expiration Date: 2022 MAY 31
Strength: 20 mg
Configuration/ Count: 1 x 90 count bottle

NDC: 0071-0535-23
Lot Number: DX6031
Expiration Date: 2023 MAR 31
Strength: 40 mg
Configuration/ Count: 1 x 90 count bottle

NDC: 0071-0535-23
Lot Number: CK6260
Expiration Date: 2022 MAY 31
Strength: 40 mg
Configuration/ Count: 1 x 90 count bottle

Pfizer places the utmost emphasis on patient safety and product quality at every step in the manufacturing and supply chain process. Pfizer has notified direct consignees by letter to arrange for return of any recalled product.

Wholesalers and distributors with an existing inventory of the lots, listed in the table above, should stop use and distribution and quarantine the product immediately.

If you have further distributed the recalled product, please notify any accounts or additional locations which may have received the recalled product from you.

If you received free product through the Pfizer Patient Assistance Program (PAP) or the Pfizer Institutional Patient Assistance Program (IPAP), please check your stock immediately against the table above. If you have any of the affected product lots in your inventory, please follow the instructions above for returning the product to Sedgwick. Additionally, if you are aware of any patients to whom you dispensed the affected lots who still may have the product in their possession, please ask them to return the product to you.

Patients who are taking this product should consult with their healthcare provider or pharmacy to determine if they have the affected product.

Company name: Pfizer
Brand name: Pfizer
Product recalled: Accupril (Quinapril HCl) tablets 10mg, 20mg, 40 mg
Reason of the recall: Due to N-Nitroso-Quinapril Content
FDA Recall date: April 22, 2022

Source: fda.gov

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Babyganics is voluntarily recalling two lots of 20-ounce bottles of babyganics® 20oz chamomile verbena bubble bath, due to the presence of the bacterium Pluralibacter gergoviae. The products were sold in the last two months only at select retailers in the U.S.

During internal testing related to product... See More shelf life across the Babyganics bubble bath line, it was discovered that two specific lot numbers of this product contained the bacterium. While infants may be more susceptible than adults, Pluralibacter gergoviae does not usually cause healthy individuals to become sick. However, it may pose a risk of infection to those who are immunocompromised or have broken or irritated skin, such as diaper rash.

The only products affected are babyganics® 20oz chamomile verbena bubble bath UPC 8 13277 01375 4 with lot codes Y314 and Y315 found at the bottom of the packaging and contained in a white plastic bottle with a green plastic lid.

The testing confirmed that no other Babyganics products contained this bacterium. Babyganics takes pride in its commitment to vigorous consumer safety standards and providing peace of mind for parents, which is why the decision was made to voluntarily recover these bottles from retailers and to proactively reach out to consumers. Consumers with the affected product will be provided with a full refund after submitting their product and contact information at the company website. Consumers who have come into contact with the affected product and aren’t feeling well should contact their doctor.

Company name: Babyganics
Brand name: Babyganics
Product recalled: Chamomile verbena bubble bath
Reason of the recall: Presence of the bacterium Pluralibacter gergoviae, a bacterium
FDA Recall date: April 20, 2022

Source: fda.gov
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St. Paul, Minnesota, Fagron Inc. (“Fagron”) is voluntarily recalling two lots of SyrSpend SF Cherry to the hospital, pharmacy, and distributor level out of an abundance of caution. The affected lots are potentially contaminated with Burkholderia gladioli.

Burkholderia gladioli is an opportunistic pathogen most commonly affecting patients... See More with respiratory disease. Patients with compromised immune systems such as those with Cystic Fibrosis are at higher risk. Burkholderia gladioli also can cause complications after transplants. Exposure to contaminated product could lead to adverse events, which could be severe for at-risk individuals.

Fagron has received three complaints regarding an undesirable smell associated with the product. To date, Fagron has not received any reports of adverse events related to the product being recalled. Fagron sells this product for the extemporaneous compounding of prescriptions for oral dosing. The affected lots with expiration dates are listed below.

Affected products:
Lot: A67185
Item number: 805359
Size: 500 mL
NDC number: 51552-1123-5
Expiration date: 08/31/2024

Lot: A67186
Item number: 802496
Size: 4 L
NDC number:51551-1123-9
Expiration date: 08/31/2024

Fagron has already notified its distributors and customers by phone, e-mail, and/or letter and is arranging for return of all recalled products. Hospitals, pharmacies, and distributors that possess affected product should quarantine this material and await further instructions from Fagron or Fagron’s recall coordinator. Please immediately discontinue use or distribution of the recalled product. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this product.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Company name: Fagron Inc.
Brand name: Fagron
Product recalled: SyrSpend SF 500mL and 4L
Reason of the recall: Potential contamination with Burkholderia gladioli
FDA Recall date: May 02, 2022

Source: fda.gov
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Royal Philips (NYSE: PHG, AEX: PHIA), today announced that its subsidiary Philips Respironics is notifying customers of its V60/V60 Plus and V680 ventilators about a potential issue with the electrical circuit in these ventilators that controls the 35V power supply to the ventilator and alarm. Philips Respironics... See More has identified that there is a possibility that affected ventilator units may cease to operate, potentially without setting off an audible/visual alarm (a so-called silent shutdown), and the patient may no longer receive respiratory assistance.

Philips Respironics projects an average of less than one silent shutdown among one million uses per year. Philips Respironics is advising customers that they must implement one or more of the following actions to mitigate the rare possibility of the hazard caused by the 35V electric circuit issue:

- Implement an oxygen analyzer with appropriate alarm settings for each V60/V60 Plus, or V680; and/or
- Connect the V60/V60 Plus or V680 to a nurse call/remote alarm system, as documented in the instructions for use; upon request, Philips Respironics can provide technical assistance to implement this nurse call/remote alarm capability; and/or
- Monitor the patient with pulse oximetry or other physiological monitoring appropriate to the institution’s capabilities and patient needs.

Additionally:
- An alternative means of ventilation should be available whenever the V60/V60 Plus or V680 ventilator is in use. If a fault is detected in the ventilator, disconnect the patient from it and immediately start ventilation with such an alternative device. The ventilator must be removed from clinical use and serviced by authorized service personnel.

If these mitigations are not available, Philips Respironics recommends each institution deliberately make a decision that balances the risks and benefits of continued use of the V60/V60 Plus and V680 against the risks and benefits of ceasing use and/or substituting other ventilators. Such decision-making should consider the institution’s capabilities and patient needs.

Philips Respironics is committed to addressing the issue and will provide regular updates to customers on the development of its plan to address the issue, with the first update to be provided before June 30, 2022. The V60/V60 Plus is not a life support ventilator. It is an assist ventilator and is intended to augment patient breathing. The V680 ventilator provides invasive and non-invasive respiratory support. The V60/V60 Plus and V680 ventilators are not authorized for use in a home or non-institutional setting.

Company name: Philips Respironics
Brand name: Philips Respironics
Product recalled: V60/V60 Plus, and V680
Reason of the recall: A potential issue with the electrical circuit in these ventilators that controls the 35V power supply to the ventilator and alarm
FDA Recall date: May 02, 2022

Source: fda.gov
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Natural Organics, Inc., is voluntarily recalling four lots of NaturesPlus Keto Living Sugar Control Capsules 90 count, because it was found to contain gluten. People who have allergies to wheat or gluten run the risk of serious or life-threatening allergic reactions if they consume these products. There... See More have been no reported incidents of illness or adverse reactions in connection with these products to date.

Individuals with Gluten intolerance may experience minor to severe reactions after consuming this product. This could include upset stomach, diarrhea, fatigue, skin reactions and more. It was discovered during routine testing that the product contains gluten. It was subsequently discovered that a raw material that is normally gluten free tested positive for gluten.

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The listed products were distributed nationwide to consumers, retail stores and to the following foreign countries: Kenya, Spain, Trinidad, United Arab Emirates, and the United Kingdom. The capsules are packaged in white jars and black caps; with labels having orange, white and black print bearing the product codes, lot numbers and “Best By” or “BBE” (Best Before End) dates are printed on the bottom of the bottle.

The lots affected are:

- NATURES PLUS KETO LIVING SUGAR CONTROL CAPSULES, 90 CAPSULES, Product No. 82004, UPC Code 097467820043, Lots 1362073, Best By 10/2025 and 1365200, Best By 10/2025
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Consumers who may have purchased affected lots of NaturesPlus Keto Living Sugar Control Capsules are advised to return them to the place of purchase. No other Natural Organics, Inc. products are affected by this recall. Natural Organics, Inc. has removed all affected products within existing inventory.

This voluntary recall is announced in accord with FDA guidelines. We are initiating recall notices to our accounts and consumers who received inventory of the recalled products with instructions for returning the recalled products and for notifying their customers of the recall. Consumers with questions may contact the company Monday – Friday, from 8:00 am to 4:30pm EDT.

Company name: NATURAL ORGANICS, INC
Brand name: NaturesPlus
Product recalled: Keto Living Sugar Control Capsules
Reason of the recall: Undeclared Gluten
FDA Recall date: May 06, 2022

Source: fda.gov
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