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Healthy Sense and People’s Choice Daily multi vitamin with Iron and Women’s daily vitamin with iron - recalled due to due to components lower than declared, USA

2 weeks ago

United States

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 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

472


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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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