Pfizer is voluntarily recalling Accuretic (quinapril HCl/hydrochlorothiazide) tablets distributed by Pfizer as well as two authorized generics distributed by Greenstone (quinapril and hydrochlorothiazide and quinapril HCl/ hydrochlorothiazide) to the patient (consumer/user) level due to the presence of a nitrosamine, N-nitroso-quinapril, above the Acceptable Daily Intake (ADI) level. Pfizer will recall six lots of Accuretic tablets, one lot of quinapril and hydrochlorothiazide tablets and four lots of quinapril HCl/ hydrochlorothiazide tablets.
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
These products are indicated for the treatment of hypertension. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. ii The products have a safety profile that has been established over 20 years of marketing authorization and through a robust clinical program. 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 N-nitroso-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 about alternative treatment options.
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 below. The product lots were distributed nationwide to wholesalers and Distributors in the United States and Puerto Rico from November 2019 to March 2022.
Accuretic™ (quinapril HCl/hydrochlorothiazide) tablets, 10/12.5 mg
Accuretic™ (quinapril HCl/hydrochlorothiazide) tablets, 20/12.5 mg
Accuretic™ (quinapril HCl/hydrochlorothiazide) tablets, 20/25 mg
| NDC | Lot Number | Expiration Date | Strength | Configuration/Count |
| 0071-3112-23 | FG5379 | 08/2024 | 10/12.5 mg | 1 x 90 count bottle |
| 0071-0222-23 | EA6686 | 04/2022 | 10/12.5 mg | 1 x 90 count bottle |
| 0071-5212-23 | FG5381 | 08/2024 | 20/12.5 mg | 1 x 90 count bottle |
| 0071-0220-23 | EA6665 | 04/2022 | 20/12.5 mg | 1 x 90 count bottle |
| 0071-0220-23 | CN0640 | 04/2022 | 20/12.5 mg | 1 x 90 count bottle |
| 0071-0223-23 | ET6974 | 02/2023 | 20/25 mg | 1 x 90 count bottle |
quinapril and hydrochlorothiazide tablets, 20/25 mg
quinapril HCl/hydrochlorothiazide tablets, 20/12.5 mg
quinapril HCl/hydrochlorothiazide tablets, 20/25 mg
| NDC | Lot Number | Expiration Date | Strength | Configuration/Count |
| 59762-5225-9 | FE3714 | 02/2023 | 20/25 mg | 1 x 90 count bottle |
| 59762-0220-1 | DN6931 | 03/2023 | 20/12.5 mg | 1 x 90 count bottle |
| 59762-0220-1 | ED3904 | 03/2023 | 20/12.5 mg | 1 x 90 count bottle |
| 59762-0220-1 | ED3905 | 03/2023 | 20/12.5 mg | 1 x 90 count bottle |
| 59762-0223-1 | DP3414 | 02/2023 | 20/25 mg | 1 x 90 count bottle |
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. Please conduct a sub-recall to those accounts and communicate this recall information immediately. Please request they immediately cease distribution of the affected product and promptly contact Sedgwick at 888-843-0247 (Mon.-Fri. 8:00 am – 5:00 pm ET) to obtain a Business Reply Card (BRC) to initiate the return process.
Patients who are taking this product should consult with their healthcare provider or pharmacy to determine if they have the affected product. Patients with the affected product should contact Sedgwick at 888-843-0247 (Mon.-Fri. 8:00 am – 5:00 pm ET) for instructions on how to return their product and obtain reimbursement for their cost.
Healthcare Professionals with questions regarding this recall can contact Pfizer using the below information.
| Contact Center | Contact Information | Area of Support |
| Pfizer Medical Information
Pfizer Drug Safety |
800-438-1985, option 3 (Mon.- Fri. 8 am-9 pm ET) 800-438-1985, option 1 |
For medical questions regarding the product
To report adverse events and product complaints |
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
- Complete and submit the report Online
- Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800- FDA-0178
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
References:
i https://www.fda.gov/drugs/drug-safety-andavailability/information-about-nitrosamine-impurities-medications
ii William B, et al. 2018 ESC/ESH Guidelines for the management of arterial hypertension. Eur Heart J 2018;39:30213104. doi:10.1093/eurheartj/ehy339.
Ha and this is for fully tested drugs but we should trust an untested covid jab, boy some people must feel they were made out to be fools hey you could have listened to us conspiracy theorist’s choices right? maybe next time youll be open minded and make the right choice
There are probably some people who’s blood pressure went up after learning of this nitrosamine problem.
To those that have a hard time reading an article because they’re rushing to comment on their daily conspiracy, please note that the drug is not recalled only certain lots. Just like certain foods are recalled from time to time. You can relax your 5G controlled minds.
@ Not me
It’s easy for you to tell people to relax their 5G controlled minds. What about those who are studded with microchips, and have become automatons, into whom Bill Gates implants his thoughts? Not to mention the Big Pharma that is totally evil, until one desperately needs an antibiotic in order to survive, and the ultimate chutzpa of charging money for life sustaining medications! How about those who know with absolute certainty that there are 3 bioweapons testing sites per Ukrainian citizen, in addition to two nuclear ones? Should they relax too? They tried, but the Deep State, hellbent on mass human extinction doesn’t allow one to keep calm. Also, Zuckerberg must have something to do with it, and with stolen elections, as well.
Have I missed anyone? Imagine if all of the above entities were suddenly gone – life would become so boring, and people would have so little to complain and whisper about!
Personally, I am more concerned with rising prices for gasoline and chicken, but that’s because I cover myself with aluminum foil, which deflects all the G5 beams. Supposedly, G6 will go right through the person, at the speed of light, and make him glow, but why worry about that now, since we will all be Covided by the Democrats before that occurs?