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Auromedics Acyclovir Intravenous Product - recalled due to particulate inside the vial, USA

2 months ago

United States

East Windsor, New Jersey, Eugia US LLC (formerly AuroMedics Pharma LLC) has initiated a voluntary recall of lot number AC22006 of AuroMedics Acyclovir Sodium Injection 500 mg per 10 mL (50 mg/mL), 10 mL single dose vial to the consumer level from the U.S. market due to a product complaint for the presence of a dark red, brown and black particulate inside the vial.

Risk Statement: The administration of an intravenous product containing particulates has the potential to result in inflammation, allergic reactions, or circulatory system complications which could be life-threatening. To date, Eugia US LLC has not received reports of any adverse events or identifiable safety concerns attributed to the product consumed for this lot.

AuroMedics Acyclovir Sodium Injection 500 mg per 10 mL (50 mg/mL), contains acyclovir, a synthetic nucleoside analog, active against herpes viruses. Acyclovir Sodium Injection is indicated for the treatment of initial and recurrent mucosal and cutaneous herpes simplex (HSV- 1 and HSV-2) in immunocompromised patients and initial clinical episodes of herpes genitalis in immuno-competent patients. It is packaged in a glass vial labeled with NDC 55150-154-10. The lot being recalled is AC22006 with an expiration date of 08/2023. Eugia US LLC shipped the entire lot to wholesalers nationwide from June 8, 2022, through June 13, 2022.

The product label is as shown below: Eugia US LLC is notifying its direct consignees by recall letters and is arranging for return/ replacement of all recalled products. Wholesale customers and health professionals that have the product lot which is being recalled should immediately place the recalled lot on hold.

Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product. This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.  

In case you experienced harm from this product, it is important to report it. It can help to detect & resolve issues and prevent others from being harmed, and it enables better surveillance.

Company name: Eugia US LLC
Brand name: Auromedics
Product recalled: Acyclovir Intravenous Product
Reason of the recall: Presence of a dark red, brown and black particulate inside the vial
FDA Recall date: September 27, 2022

Source: fda.gov

474


Related Reports

Proper Trade LLC/My Stellar Lifestyle is voluntarily recalling Wonder Pill lot 20210912 and lot 31853-501, expiry 09/24, packaged in 10-count blisters co-packaged in a carton and in 60-count bottles to the consumer level. Proper Trade LLC/My Stellar Lifestyle was notified by Amazon that laboratory analysis has found... See More the product to be tainted with tadalafil, an ingredient in FDA approved products for treatment of male erectile dysfunction in the family of drugs known as phosphodiesterase (PDE-5) inhibitors. The presence of tadalafil in Wonder Pill capsules makes this product an unapproved drug for which the safety and efficacy has not been established and therefore, subject to recall.

Consumers with underlying medical issues who take the Wonder Pill with undeclared tadalafil may experience serious health risks. For example, PDE-5 inhibitors may interact with nitrates found in some prescription drugs (such as nitroglycerin) lowering blood pressure to dangerous levels that may be life-threatening. Consumers with diabetes, high blood pressure, or heart disease often take nitrates. To date, Proper Trade LLC/ My Stellar Lifestyle has not received any reports of adverse events related to this recall.

The product is marketed as a dietary supplement for male sexual enhancement and is packaged in 10-count blisters co-packaged in a carton, ASIN B0B6CWC9NK, and packaged in a 60-count bottle. The affected lots include lot numbers’ 20210912 & 31853-501, Expiry 09/24. The product can be identified by the labels below. The product was distributed via the internet and fulfilled by Amazon at www.amazon.com and Walmart at www.walmart.com, nationwide in the USA.

On December 17, 2020, FDA issued a press release that warned consumers to avoid certain products found on Amazon, eBay and other retailers due to hidden and potentially dangerous drug ingredients. It also encouraged online marketplaces to ensure these products are not sold on their platforms.

Proper Trade LLC/ My Stellar Lifestyle is notifying its customers by this press announcement and sending Amazon & Walmart messages to its customers and is arranging for return of all recalled products. Consumers that have Wonder Pill capsules which is being recalled should stop using the product.

Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product. 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.

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

Company name: Proper Trade LLC/My Stellar Lifestyle
Brand name: My Stellar Lifestyle
Product recalled: Wonder Pill Capsules
Reason of the recall: Product contains undeclared tadalafil
FDA Recall date: September 28, 2022

Source: fda.gov
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474


Golden State Medical Supply, Incorporated (GSMS, Inc.) - Camarillo, CA has initiated a voluntary recall of the products listed in the table below because a report was received that a bottle containing Clopidogrel 75mg Tablets produced with lot# GS046745 was mislabeled as Atenolol 25mg Tablets. This voluntary... See More recall only affects products with lot# GS046745. No other Clopidogrel or Atenolol products marketed by GSMS, Inc. are impacted. Both products are being recalled out of abundance of caution.

-Recalled products:
Product Description: Clopidogrel 75mg Tablets, 1,000 Count Bottle, GSMS NDC: 51407-032-10, Lot #: GS046745, Expiration Date: 12/2023
Product Description: Atenolol 25mg Tablets, 1,000 Count Bottle, GSMS NDC: 60429-027-10, Lot #: GS046745, Expiration Date: 12/2023

Atenolol tablets are indicated for the treatment of hypertension, to lower blood pressure. Clopidogrel is prescribed to lower the risk of having a stroke, blood clot, or serious heart problem for patients who have had heart attack, severe chest pain, or circulation problems as indicated in the product labeling. For more drug label information about clopidogrel bisulfate visit: DailyMed - CLOPIDOGREL- clopidogrel bisulfate tablet, film coated (nih.gov). For more drug label information about atenolol visit: DailyMed - ATENOLOL tablet (nih.gov)

Patients who suddenly stop taking atenolol, as would happen if clopidogrel were misplaced in the atenolol-labeled bottle, are at increased risk for ischemic (angina, myocardial infarction), hypertensive and arrhythmic adverse events relating to rapid withdrawal of beta antagonism. Further, patients who are on atenolol are frequently on concomitant anticoagulant and antiplatelet medications and would be at increased risk for bleeding if clopidogrel were added to the regimen. To date, GSMS, Inc. has not received any reports of adverse events related to the use of the products as part of this recall.

The lot under GSMS, Inc.’s voluntary recall has been primarily sold to AmerisourceBergen, and McKesson. AmerisourceBergen and McKesson are instructed to immediately stop distribution, quarantine all remaining products in their control, and return the recalled product to GSMS, Inc. They are also instructed to provide their customers, i.e., pharmacies and consumers, a copy of GSMS, Inc.’s recall notification, recall response form, and letter to consumers, patients, and caregivers.

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

In case you experienced harm from these products, it is important to report it. It can help to detect & resolve issues and prevent others from being harmed, and it enables better surveillance.

Company name: Golden State Medical Supply, Incorporated
Brand name: Golden State Medical Supply, Incorporated
Product recalled: Clopidogrel 75mg Tablets, Atenolol 25mg Tablets
Reason of the recall: Due to Label Mix-up
FDA Recall date: September 29, 2022

fda.gov
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474


Exela Pharma Sciences, LLC, (Exela) is voluntarily recalling 49 lots of Sodium Bicarbonate Injection, USP, 8.4%, 50 mEq/50 mL vial, 20count carton, to the consumer level. Product was distributed nationwide to wholesalers, distributors, and other customers between December 16, 2021 and August 10, 2022.

Risk Statement: The... See More product poses a potential safety concern with vial breakage and flying glass when pressurized while preparing the product for administration. Exela has received five (5) reports of flying glass injuring skin, eye and/or other parts. There have been no reports of sterility failures.

The product is used for treatment of metabolic acidosis and is packaged in a 50 mL glass vial, 20 vials per carton. The vials are labeled with Exela brand (Carton NDC: 51754-5001-5; Vial NDC: 51754-5001-1, Image 1) and Civica brand (Carton NDC: 72572-740-20; Vial NDC: 72572-740-1, Image 2).

The affected Sodium Bicarbonate Injection, USP, 8.4%, 50 mEq/50 mL lots (covering both Exela and Civica brands) include the following lot numbers and expiration dates:

- Brand (Exela). Lot: P0001370. Expire Date: 10/23.
- Brand (Exela). Lot: P0001371. Expire Date: 10/24.
- Brand (Exela). Lot: P0001372. Expire Date: 10/23.
- Brand (Exela). Lot: P0001433. Expire Date: 11/23.
- Brand (Exela). Lot: P0001434. Expire Date: 11/23.
- Brand (Exela). Lot: P0001443. Expire Date: 12/23.
- Brand (Exela). Lot: P0001468. Expire Date: 12/23.
- Brand (Exela). Lot: P0001469. Expire Date: 12/23.
- Brand (Exela). Lot: P0001470. Expire Date: 12/23.
- Brand (Exela). Lot: P0001495. Expire Date: 12/23.
- Brand (Exela). Lot: P0001505. Expire Date: 12/23.
- Brand (Exela). Lot: P0001506. Expire Date: 12/23.
- Brand (Exela). Lot: P0001509. Expire Date: 12/23.
- Brand (Exela). Lot: P0001510. Expire Date: 12/23.
- Brand (Exela). Lot: P0001511. Expire Date: 12/23.
- Brand (Exela). Lot: P0001512. Expire Date: 12/23.
- Brand (Exela). Lot: P0001560. Expire Date: 01/24.
- Brand (Exela). Lot: P0001561. Expire Date: 01/24.
- Brand (Exela). Lot: P0001562. Expire Date: 01/24.
- Brand (Exela). Lot: P0001564. Expire Date: 01/24.
- Brand (Exela). Lot: P0001566. Expire Date: 01/24.
- Brand (Exela). Lot: P0001567. Expire Date: 01/24.
- Brand (Exela). Lot: P0001568. Expire Date: 01/24.
- Brand (Exela). Lot: P0001571. Expire Date: 02/24.
- Brand (Exela). Lot: P0001572. Expire Date: 02/24.
- Brand (Exela). Lot: P0001573. Expire Date: 02/24.
- Brand (Exela). Lot: P0001574. Expire Date: 02/24.
- Brand (Exela). Lot: P0001578. Expire Date: 02/24.
- Brand (Exela). Lot: P0001579. Expire Date: 02/24.
- Brand (Exela). Lot: P0001580. Expire Date: 02/24.
- Brand (Exela). Lot: P0001583. Expire Date: 02/24.
- Brand (Exela). Lot: P0001586. Expire Date: 02/24.
- Brand (Exela). Lot: P0001587. Expire Date: 02/24.
- Brand (Exela). Lot: P0001588. Expire Date: 02/24.
- Brand (Exela). Lot: P0001593. Expire Date: 02/24.
- Brand (Exela). Lot: P0001594. Expire Date: 02/24.
- Brand (Exela). Lot: P0001610. Expire Date: 02/24.
- Brand (Exela). Lot: P0001618. Expire Date: 02/24.
- Brand (Exela). Lot: P0001619. Expire Date: 02/24.
- Brand (Exela). Lot: P0001644. Expire Date: 03/24.
- Brand (Exela). Lot: P0001645. Expire Date: 03/24.
- Brand (Exela). Lot: P0001646. Expire Date: 03/24.
- Brand (Exela). Lot: P0001654. Expire Date: 02/24.
- Brand (Exela). Lot: P0001662. Expire Date: 03/24.
- Brand (Exela). Lot: P0001664. Expire Date: 03/24.
- Brand (Exela). Lot: P0001730. Expire Date: 05/24.
- Brand (Civica). Lot: P0001497. Expire Date: 12/23.
- Brand (Civica). Lot: P0001600. Expire Date: 02/24.
- Brand (Civica). Lot: P0001663. Expire Date: 03/24.

The Exela product (Carton NDC: 51754-5001-5; Vial NDC: 51754-5001-1) can be identified by the NDC numbers, and by the yellow flip-top safety cap on the 50 mL vial. The carton bears a purple stripe containing concentration information and the manufacturer name “Exela Pharma Sciences” in the lower right-hand corner. The vial label bears a purple stripe containing concentration information with the name “Exela Pharma Sciences” on the back.

The Civica Product (Carton NDC: 72572-740-20; Vial NDC: 72572-740-1) can be identified by the NDC numbers, by the yellow flip-top safety cap on the 50 mL vial, and by the carton which bears a green stripe containing concentration information and the manufacturer name “Civica” in the lower right-hand corner. The vial label bears a green stripe containing concentration information with the name “Civica” on the back.

All the above-listed lots are supplied in 20 count cartons only. This recall is not expected to cause drug shortage.

Exela is notifying its customers by e-mail and certified mail and is arranging for return and replacement of all recalled product directly to Exela. Customers that have product which is being recalled should discontinue use, segregate the recalled product, submit a recall stock response form to Exela (even if there is no product to return), and hold the product until shipment instructions are provided by Exela.

In case you experienced harm from these products, it is important to report it. It can help to detect & resolve issues and prevent others from being harmed, and it enables better surveillance.

Company name: Exela Pharma Sciences, LLC
Brand name: Exela & Civica
Product recalled: Sodium Bicarbonate Injection, USP, 8.4%, 50 mEq/50 mL vial
Reason of the recall: Vial Breakage
FDA Recall date: October 13, 2022

Source: fda.gov
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474


East Windsor, New Jersey, Aurobindo Pharma USA, Inc. has initiated a voluntary recall of two (2) lots (refer table below) of Quinapril and Hydrochlorothiazide Tablets USP 20mg / 12.5mg, to the consumer level from the US market due to presence of Nitrosamine Drug Substance Related Impurity (NDSRI),... See More N-Nitroso-Quinapril above the proposed interim limit. Aurobindo Pharma USA, Inc. began shipping of the subject batches, QE2021005-A and QE2021010-A to customers nationwide May 2021.

-Affected product:
NDC No.: 65862-162-90, Product Name, strength, and pack: Quinapril and Hydrochlorothiazide Tablets USP, 20mg / 12.5mg, 90’s HDPE bottle, Lot number: QE2021005-A; QE2021010-A, Expiry: 01/2023

Risk Statement: 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. To date, Aurobindo Pharma USA, Inc. has not received any reports of adverse events related to this recall.

Quinapril and Hydrochlorothiazide Tablets, USP are fixed-combination tablet that combines an angiotensin-converting enzyme (ACE) inhibitor, quinapril hydrochloride, and a thiazide diuretic, hydrochlorothiazide. This product is indicated for the treatment of hypertension, to lower blood pressure. Patients should contact their doctor or health care provider about whether to continue taking their medication, or whether to consider an alternative treatment prior to returning their medication.

Quinapril and Hydrochlorothiazide Tablets USP 20 mg / 12.5 mg are “Pink colored, scored, round shaped, biconvex, film-coated tablets, debossed with ‘D’ on scored side and ‘19’on other side”, supplied in 90’s HDPE bottle.

Qualanex, on behalf of Aurobindo Pharma USA, Inc., will be notifying its distributors and customers by phone and in writing to immediately discontinue distribution of the specific lots being recalled and to notify their sub-accounts. Aurobindo Pharma USA, Inc. is arranging for return of all recalled products to Qualanex. Instructions for returning recalled products are given in the recall letter.

Consumers should also contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

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

In case you experienced harm from this product, it is important to report it. It can help to detect & resolve issues and prevent others from being harmed, and it enables better surveillance.

Company name: Aurobindo Pharma USA, Inc.
Brand name: Aurobindo Pharma USA, Inc.
Product recalled: Quinapril and Hydrochlorothiazide Tablets USP, 20mg / 12.5mg, 90’s HDPE bottle
Reason of the recall: Due to presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Quinapril
FDA Recall date: October 25, 2022

Source: fda.gov
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474


Mylan Institutional LLC, a Viatris company, is voluntarily recalling lot AJ21002, exp 3/2024, of Octreotide Acetate Injection, 500 mcg/mL, packaged in a carton of ten 1mL syringes. This lot is being recalled at the user (hospital/pharmacy) level due to a product complaint of the presence of glass... See More particles in a syringe. This lot was manufactured by Italfarmaco SpA, Italy and was distributed by Mylan Institutional LLC in the US between January 11 and June 21, 2022. To date, no reports of adverse reactions associated with this lot have been received.

The recalled lot is as follows:

NDC #: 67457-246-00 (Syringe); 67457-246-01 (Carton), Name and Strength: Octreotide Acetate Injection 500 mcg/mL, Size: 10 X 1 mL Single dose unit-of-use Syringe. Lot#: AJ21002, Expiry: March 2024

Intravenous administration of a solution containing particulate matter, such as a glass, could lead to events including, but not limited to, local irritation or swelling, vasculitis/phlebitis, antigenic or allergic reactions, and microvascular obstruction, including pulmonary embolism. Although the intravenous administration of a solution containing particulate matter may pose potential risk of serious adverse events, the probability of exposure from this incident and subsequent risk is low.

Octreotide Acetate Injection is indicated to reduce blood levels of growth hormone (GH) and insulin growth factor-1 (IGF-1; somatomedin C) in acromegaly patients who have had inadequate response to or cannot be treated with surgical resection, pituitary irradiation, and bromocriptine mesylate at maximally tolerated doses. It is also indicated for the symptomatic treatment of patients with metastatic carcinoid tumors where it suppresses or inhibits the severe diarrhea and flushing episodes associated with the disease and for the treatment of the profuse watery diarrhea associated with vasoactive intestinal peptide (VIP)-secreting tumors.

The company has initiated the recall of lot AJ21002 and notified its distributors by letter/phone and is arranging for return of all recalled products. Following are actions for wholesalers and retailers/users (hospitals/pharmacies):

Wholesalers: Immediately examine your inventory, quarantine and discontinue distribution of this lot.

Retailers/Users (Hospitals/Pharmacies): Immediately examine your inventory, quarantine and discontinue distribution of this lot.

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

In case you experienced harm from this product, it is important to report it. It can help to detect & resolve issues and prevent others from being harmed, and it enables better surveillance.

Company name: Mylan Institutional LLC, a Viatris company
Brand name: Mylan Institutional LLC
Product recalled: Octreotide Acetate Injection, 500 mcg/mL
Reason of the recall: Due to glass particulates
FDA Recall date: October 25, 2022

Source: fda.gov
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474


Mason Vitamins Inc. has issued a nationwide voluntary recall of the specific lot of Healthy Sense Daily Multiple with Iron and People’s Choice Women's Daily Vitamins with Iron due to Vitamin A, Vitamin B12, Vitamin C, Vitamin E and Pantothenic Acid amounts being lower than the declared... See More amount on the label which was determined during an FDA inspection. The products were sold nationwide at Bargain Barn, 99 Cents Only, Fruth Pharmacy, Joe V’s Smart Shop, Rose’s Discount Stores, Rex Discount Pharmacy, Star Discount Pharmacy, Propst Discount Pharmacy, Dollar Tree and limited distributors. To date, no illnesses related to these products have been reported.

Product Name: Healthy Sense Daily Multiple with Iron, Size: 20 tablets, UPC Code: 311845353238, Lot/Expiration Date: 25807G / 09/2024
Product Name: People’s Choice Women’s Daily Vitamins with Iron, Size: 30 tablets, UPC Code: 311845486882, Lot/Expiration Date: 25807G / 09/2024; A25807G / 09/2024; B25807G / 09/2024;C25807G / 09/2024; D25807G / 09/2024

No other People’s Choice and Healthy Sense products are affected by this recall. If customers have product affected by this voluntary recall, they should discard it immediately.

In case you experienced harm from these products, it is important to report it. It can help to detect & resolve issues and prevent others from being harmed, and it enables better surveillance.

Company name: Mason Vitamins Inc.
Brand name: Healthy Sense and People’s Choice
Product recalled: Daily multi vitamin with Iron and Women’s daily vitamin with iron
Reason of the recall: Due to Vitamin 1, B12, C, E and Pantothenic Acid being lower than declared
FDA Recall date: November 17, 2022

Source: fda.gov
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474


Exela Pharma Sciences, LLC, (Exela) is expanding their recall, adding fourteen (14) lots to the ongoing voluntary recall of forty-nine (49) lots of Sodium Bicarbonate Injection, USP, 8.4%, 50 mEq/50 mL vial, 20-count carton. A total of 63 lots are now being recalled to the consumer level.... See More All the recalled lots are listed in the table below, with the additional fourteen (14) lots shown in BOLD and RED. The additional lots were distributed October 26, 2021 through April 25, 2022. Product was distributed nationwide to wholesalers, distributors, and other customers between October 26, 2021 and August 10, 2022. There have been no reports of sterility failures to date with any of the sixty-three (63) lots.

Risk Statement: The product poses a potential safety concern with vial breakage and flying glass when pressurized while preparing the product for administration. There is a potential of flying glass injuring skin, eye and/or other parts which could result in either temporary or permanent injury. Within the sixty-three (63) total recalled lots (which includes more than 2.7 million vials), Exela has received five (5) reports of flying glass injuring skin, eye and/or other parts. There have been no complaints of vial breakage or injuries related to the additional fourteen (14) lots.

Exela did not recall the additional fourteen (14) lots previously because they did not appear to be impacted. During the latest inspection of Exela’s retain product from the fourteen (14) lots, one (1) vial showed breakage. There have been no field reports of personal injury to date across all the sixty-three (63) lots since the recall process started. However, out of an abundance of caution, Exela is adding the 14 lots to the on-going recall. The product is used for treatment of metabolic acidosis and is packaged in a 50 mL glass vial, 20 vials per carton. The vials are labeled with Exela brand (Carton NDC: 51754-5001-5; Vial NDC: 51754-5001-1, Figure 1) and Civica brand (Carton NDC: 72572-740-20; Vial NDC: 72572-740-1, Figure 2). The affected Sodium Bicarbonate Injection, USP, 8.4%, 50 mEq/50 mL lots (covering both Exela and Civica brands) include the following lot numbers and expiration dates:

- Brand : Exela . Lot : P0001178 . Expire Date: 05/2023.
- Brand : Exela . Lot : P0001298 . Expire Date: 08/2023.
- Brand : Exela . Lot : P0001301 . Expire Date: 08/2023.
- Brand : Exela . Lot : P0001313 . Expire Date: 08/2023.
- Brand : Exela . Lot : P0001314 . Expire Date: 08/2023.
- Brand : Exela . Lot : P0001317 . Expire Date: 08/2023.
- Brand : Exela . Lot : P0001330 . Expire Date: 09/2023.
- Brand : Exela . Lot : P0001370 . Expire Date: 10/2023.
- Brand : Exela . Lot : P0001371 . Expire Date: 10/2023.
- Brand : Exela . Lot : P0001372 . Expire Date: 10/2023.
- Brand : Exela . Lot : P0001433 . Expire Date: 11/2023.
- Brand : Exela . Lot : P0001434 . Expire Date: 11/2023.
- Brand : Exela . Lot : P0001442 . Expire Date: 11/2023.
- Brand : Exela . Lot : P0001443 . Expire Date: 12/2023.
- Brand : Exela . Lot : P0001464 . Expire Date: 09/2023.
- Brand : Exela . Lot : P0001467 . Expire Date: 12/2023.
- Brand : Exela . Lot : P0001468 . Expire Date: 12/2023.
- Brand : Exela . Lot : P0001469 . Expire Date: 12/2023.
- Brand : Exela . Lot : P0001470 . Expire Date: 12/2023.
- Brand : Exela . Lot : P0001472 . Expire Date: 12/2023.
- Brand : Exela . Lot : P0001486 . Expire Date: 12/2023.
- Brand : Exela . Lot : P0001495 . Expire Date: 12/2023.
- Brand : Exela . Lot : P0001505 . Expire Date: 12/2023.
- Brand : Exela . Lot : P0001506 . Expire Date: 12/2023.
- Brand : Exela . Lot : P0001509 . Expire Date: 12/2023.
- Brand : Exela . Lot : P0001510 . Expire Date: 12/2023.
- Brand : Exela . Lot : P0001511 . Expire Date: 12/2023.
- Brand : Exela . Lot : P0001512 . Expire Date: 12/2023.
- Brand : Exela . Lot : P0001532 . Expire Date: 12/2023.
- Brand : Exela . Lot : P0001560 . Expire Date: 01/2024.
- Brand : Exela . Lot : P0001561 . Expire Date: 01/2024.
- Brand : Exela . Lot : P0001562 . Expire Date: 01/2024.
- Brand : Exela . Lot : P0001564 . Expire Date: 01/2024.
- Brand : Exela . Lot : P0001566 . Expire Date: 01/2024.
- Brand : Exela . Lot : P0001567 . Expire Date: 01/2024.
- Brand : Exela . Lot : P0001568 . Expire Date: 01/2024.
- Brand : Exela . Lot : P0001571 . Expire Date: 02/2024.
- Brand : Exela . Lot : P0001572 . Expire Date: 02/2024.
- Brand : Exela . Lot : P0001573 . Expire Date: 02/2024.
- Brand : Exela . Lot : P0001574 . Expire Date: 02/2024.
- Brand : Exela . Lot : P0001578 . Expire Date: 02/2024.
- Brand : Exela . Lot : P0001579 . Expire Date: 02/2024.
- Brand : Exela . Lot : P0001580 . Expire Date: 02/2024.
- Brand : Exela . Lot : P0001583 . Expire Date: 02/2024.
- Brand : Exela . Lot : P0001586 . Expire Date: 02/2024.
- Brand : Exela . Lot : P0001587 . Expire Date: 02/2024.
- Brand : Exela . Lot : P0001588 . Expire Date: 02/2024.
- Brand : Exela . Lot : P0001593 . Expire Date: 02/2024.
- Brand : Exela . Lot : P0001594 . Expire Date: 02/2024.
- Brand : Exela . Lot : P0001610 . Expire Date: 02/2024.
- Brand : Exela . Lot : P0001618 . Expire Date: 02/2024.
- Brand : Exela . Lot : P0001619 . Expire Date: 02/2024.
- Brand : Exela . Lot : P0001644 . Expire Date: 03/2024.
- Brand : Exela . Lot : P0001645 . Expire Date: 03/2024.
- Brand : Exela . Lot : P0001646 . Expire Date: 03/2024.
- Brand : Exela . Lot : P0001654 . Expire Date: 02/2024.
- Brand : Civica . Lot : P0001490 . Expire Date: 12/2023.
- Brand : Civica . Lot : P0001497 . Expire Date: 12/2023.
- Brand : Civica . Lot : P0001600 . Expire Date: 02/2024.
- Brand : Civica . Lot : P0001663 . Expire Date: 03/2024.

The Exela product (Carton NDC: 51754-5001-5; Vial NDC: 51754-5001-1) can be identified by the NDC numbers, and by the yellow flip-top safety cap on the 50 mL vial. The carton bears a purple stripe containing concentration information and the manufacturer name “Exela Pharma Sciences” in the lower right-hand corner. The vial label bears a purple stripe containing concentration information with the name “Exela Pharma Sciences” on the back.

The Civica Product (Carton NDC: 72572-740-20; Vial NDC: 72572-740-1) can be identified by the NDC numbers, by the yellow flip-top safety cap on the 50 mL vial, and by the carton which bears a green stripe containing concentration information and the manufacturer name “Civica” in the lower right-hand corner. The vial label bears a green stripe containing concentration information with the name “Civica” on the back.

All the above-listed lots are supplied in 20 count cartons only. This recall is not expected to cause drug shortage.

Customers that have product which is being recalled should discontinue use, segregate the recalled product, submit a recall stock response form to Exela (even if there is no product to return).

In case you experienced harm from this product, it is important to report it. It can help to detect & resolve issues and prevent others from being harmed, and it enables better surveillance.

Company name: Exela Pharma Sciences, LLC
Brand name: Exela
Product recalled: Sodium Bicarbonate Injection, USP, 8.4%, 50 mEq/50 mL vial
Reason of the recall: Vial Breakage
FDA Recall date: November 29, 2022

Source: fda.gov
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Medicine for OAB Trospium Chloride 20mg - first 3 pills worked fine 4th pill not the same was like a strong diet pill kept me up all night with heart beating too fast the following days heart was still beating faster than normal - I reported the... See More problem to the pharmacy and my Doctor and discontinued the pill. It was unstable medicine did not make any sense - I was going to the bathrrom too many times at night for a long period of time | Symptoms: Diarrhea, Other See Less
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GlaxoSmithKline Consumer Healthcare ULC is recalling one lot of TUMS Peppermint Regular Strength tablets after some tablets were found to contain fragments of fibreglass and other material, including paper and aluminum foil. The product is sold in a package of three rolls containing 12 tablets each, and... See More was distributed across Canada starting on October 25, 2022.

The recalled product is:
- TUMS Peppermint Regular Strength (500mg) tablets, packages of three rolls of 12 tablets, NPN: 01970240, Lot: HA7H, Expiry: August 2027

Company name: GlaxoSmithKline Consumer Healthcare ULC
Product recalled: TUMS Peppermint Regular Strength (500mg) tablets, packages of three rolls of 12 tablets
Reason of the recall: Due to contamination fragments of fibreglass and other material
CFIA Recall date: November 30, 2022

TUMS is an antacid indicated for adult use to relieve indigestion and heartburn caused by too much acid in the stomach. If consumed, the fragments should pass through most people's digestive systems with no concern; however, elderly people and people who have narrow areas in their intestines because of disease or surgery may be at risk of injury.

Stop using the recalled product. Follow municipal or regional guidelines on how to dispose of chemicals and other hazardous waste; or Return the product to your local pharmacy for proper disposal.

In case you experience harm from this product, it is important to report it. It can help to detect & resolve issues and prevent others from being harmed, and it enables better surveillance. If symptoms persist, seek medical care.

Source: recalls-rappels.canada.ca
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60


Power has been restored at the University of Maryland College Park on Thursday after a "significant" power outage, according to the University of Maryland Police Department (UMPD).

Outage link: pepco.com
Source: wjla.com
Published: 2022-12-08 See Less


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anonymous8246
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