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Cleanliness

Updated: October 28, 2021 4:47 PM

Recent Interesting Reports

Sagent Pharmaceuticals, Inc. on November 19 announced the voluntary nationwide recall of four lots of Levetiracetam Injection, USP, to the user level. The lack of container closure integrity, found in reserve sample vials may result in a non-sterile product.

Risk Statement: Intravenous administration of a product intended... See More to be sterile that is not sterile could result in serious systemic infections which may be life-threatening. 

To date, Sagent has not received reports of any product complaints or adverse events associated with this issue. Levetiracetam Injection, USP 500 mg per 5 mL, is used in the treatment of certain types of seizures and is packaged in a 5mL single-does vial. The Levetiracetam Injection, USP, label and affected lot numbers with Expiration Dates and NDC number can be found in the table below. 

Product: Levetiracetam Injection, USP / Lot Number: B0G85VB /Expiration Date: Jun-2022 / NDC Number: 25021-780-05 / Distribution Dates: May 2021 - August 2021.

Product: Levetiracetam Injection, USP / Lot Number: B0K88VA /Expiration Date: Sep-2022 / NDC Number: 25021-780-05 / Distribution Dates: March 2021 - November 2021.

Product: Levetiracetam Injection, USP / Lot Number: B0K89VA /Expiration Date: Sep-2022 / NDC Number: 25021-780-05 / Distribution Dates: August 2021 - November 2021.

Product: Levetiracetam Injection, USP / Lot Number: B1G194A /Expiration Date: Jun-2023 / NDC Number: 25021-780-05 / Distribution Dates: October 2021.

The product was distributed Nationwide from March to November  2021.

Company name: Sagent Pharmaceuticals, Inc.
Brand name: Sagent
Product recalled: Levetiracetam Injection
Reason of the recall: Lack of sterility assurance
FDA Recall date: November 22, 2021

Check the full recall details on fda.gov

Source: FDA
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American Screening LLC of Shreveport, Louisiana is voluntarily recalling 153,336 units of Hand Sanitizer, containing 70% ethyl alcohol gel to the consumer level. The hand sanitizer is packaged in 8 oz. containers that resemble water bottles posing a risk of consumption.

Risk Statement: Ingesting hand sanitizer, which... See More is intended for topical use, could potentially result in alcohol toxicity. Symptoms of alcohol toxicity may range from lack of coordination, slowed or slurred speech, drowsiness to coma, which can be fatal. Furthermore, ingesting alcohol can affect the brain and cause impaired driving or operating heavy machinery. Alcohol can also interact with numerous drugs which may result in serious adverse effects. Ingesting alcohol by people with alcohol addiction may interfere with maintaining abstinence. Additionally, people with alcohol addiction may seek large amounts of ethanol-based hand sanitizers as a substitute. To date, American Screening LLC has not received any reports of adverse events related to this recall.

The product is intended to be applied topically to help reduce bacteria on the skin that could cause diseases when soap and water are not available and is packaged in an eight-ounce bottle. The affected hand sanitizer lots include the following expiration dates of 5/21/2022 and 05/24/2022 for black-capped bottles and no lot numbers or expiration dates for clear capped bottles. The product can be identified by its shape (small water bottle), with a black flip top cap or clear cap with blue pouring spout with the weight of measure of eight (8) ounces/237mL, UPC 8 4005051579 2.

The Hand Sanitizer was sold to customers & distributors Nationwide via the internet at americanscreeningcorp.com and/or in-house sales.

Consumers & distributors that have this hand sanitizer which is being recalled should stop distribution/use and return to place of purchase or discard. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to ingesting the hand sanitizer packaged in the 8 oz. water bottle style.

Company name: American Screening LLC
Brand name: American Screening
Product recalled: Hand Sanitizer
Reason of the recall: Hand sanitizer is packaged in 8 oz. containers that resemble water bottles posing a risk of consumption
FDA Recall date: November 19, 2021

Check the full recall details on fda.gov

Source: FDA
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I shipped Priority Express on Nov 15 to Essex Junction, VT and after two days it is still showing arrived at Teterboro Distribution Center, Industrial Avenue, Teterboro, NJ, USA on 11/15/2021 at 9:22pm. It should be delivered by Nov 16 at VT See Less
5.4K


I have been applying since the beginning of the month I went to two different appointments and every three hours the system messes up and thinks that I haven’t done my steps See Less
1.2K


Package was supposed to be delivered November 6, 2021.
After days of endless calls finally told it left teterboro post office November 5 but was never delivered or tracked since. See Less
5.4K


The Procter & Gamble Company (NYSE: PG) is voluntarily recalling all lots with expiry through September 2023 of specific Old Spice and Secret aerosol spray antiperspirants and Old Spice Below Deck aerosol spray products sold in the United States, and listed in the table below, to the... See More consumer level due to the presence of benzene detected.

Risk Statement: Benzene is classified as a human carcinogen. Exposure to benzene can occur by inhalation, orally, and through the skin and it can result in cancers including leukemia and blood cancer of the bone marrow and blood disorders which can be life-threatening. Based on exposure modeling and the cancer risk assessments published by the Environmental Protection Agency (EPA) (IRIS database), daily exposure to benzene in the recalled products at the levels detected in our testing would not be expected to cause adverse health consequences. Benzene is ubiquitous in the environment. Humans around the world have daily exposures to it indoors and outdoors from multiple sources. To date, The Procter & Gamble Company has not received any reports of adverse events related to this recall and is conducting this recall out of an abundance of caution.

The affected products are used as antiperspirants and hygiene products and are packaged in aerosol cans. See the link below for Product names and UPC codes and images for further descriptions. They are recalling all lots with expiry through September 2023 of the products listed in the link below.

Company name: The Proctor & Gamble Company
Brand name: Old Spice Secret
Product recalled: Old Spice and Secret Aerosol Sprays
Reason of the recall: Due to the presence of benzene
FDA Recall date: November 23, 2021

Check the full recall details on fda.gov

Source: FDA
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FOR IMMEDIATE RELEASE – December 1, 2021 – Princeton, NJ, Sandoz Inc. (“Sandoz”) is initiating a recall of one lot (SAB06761A, Exp 04/2023) of Enoxaparin Sodium Injection, USP 40 mg/0.4 mL Single-Dose Syringes to the consumer level. A portion of lot SAB06761A experienced a temperature excursion during... See More shipment. Enoxaparin Sodium for Injection Lot SAB06761A was shipped to customers in the months of September and October 2021.

The exposure to higher temperatures may have significantly impacted the recalled product’s (lot SAB06761A) effectiveness and thus there may be reasonable probability of risk for patients with health conditions that the product is intended to treat. Such patients could be at risk for blood clots blocking blood vessels, an artery, or traveling to other tissues or organs causing pain, swelling, stroke, clots to the lung or death as a result of the underlying condition. To date, Sandoz has not received any reports of adverse events or injuries related to this recall.

The product is used for prevention of deep vein thrombosis (DVT) a condition that occurs when a blood clot forms in a deep vein, usually in the legs that can occur after surgeries or in patients with restricted mobility during illness; or prevention of complications associated with heart attacks. The product is packaged in cartons containing ten 0.4 mL syringes, NDC 0781-3246-64. Enoxaparin Sodium Injection was distributed Nationwide in the USA to wholesalers and retailers.

Product Name: Enoxaparin Sodium, Injection, USP 40mg/0.4 mL
NDC Number: 00781-3246-64
Lot Number: SAB06761A
Expiration Date: 04/2023
Date of Manufacture: 05/26/2021

Please note: this recall is specific to only one batch (SAB06761A) of Enoxaparin Sodium Injection, USP 40 mg/0.4 mL and does not apply to any other strengths of Sandoz Enoxaparin Sodium Injection, USP or to other lots of the 40 mg/0.4 mL SKU.

Any product returned that is not associated with this recall will be destroyed and no credit issued.

Company name: Sandoz, Inc.
Brand name: Sandoz
Product recalled: Enoxaparin Sodium Injection
Reason of the recall: Exposure to high temperatures may have impacted product effectiveness.
FDA Recall date: December 02, 2021

Check the full recall details on fda.gov

Source: FDA
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Mountain Meadow Herbs of Somers, MT is recalling 54 bottles (total 240 capsules per bottle) of Mountain Meadow Herbs brand Candida Flush, Lot# 0120011Q. Some bottles from this Lot have become pressurized over time in storage. When opened, the product may forcefully expel air as well as... See More portions of capsules and powder. This may result in customers sustaining injuries to their hands and eyes, which may require medical attention.

Product was distributed to retailers in IN, MN, MT, NY, TN and in Ontario of Canada.
Product was sold directly to consumers in IN, KY, MN, MO, MT, NE, OH, PA, VA, and WI. The affected Candida Flush has the UPC 8 13086 01593 2, Lot #012001l Q, Exp 12/22.

No illnesses or serious injuries have been reported to date. The recall was the result of an internal investigation stemming from a customer complaint which revealed that the finished products were becoming pressurized over time.

This recall is being made with the knowledge of the U.S. Food and Drug Administration. If you have any of these products, please dispose of them immediately.

Company name: Mountain Meadow Herbs
Brand name: Mountain Meadow Herbs
Product recalled: Candida Flush
Reason of the recall: Due to exploding bottle risk
FDA Recall date: November 17, 2021

Check the full recall details on fda.gov

Source: FDA
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Nutracap Holdings, LLC of Norcross, Georgia is voluntarily recalling various dietary supplements due to undeclared wheat, milk, soy and/or coconut on the labels. People who have an allergy or severe sensitivity to soy, milk, wheat, or coconut run the risk of serious or life-threatening allergic reaction if... See More they consume products containing soy, milk, wheat, or coconut.

On 11/4/2021 during an FDA inspection the firm was notified that their labels failed to disclose the presence of allergens on some of their products. The recalled products were shipped between June 4, 2020 through October 1, 2021 to distributors and retailers in Alabama, California, Florida, and Texas. There have been no illnesses reported to date.

The affected products are:

Brand: Boba Origin. Product: 100% Whey Protein Isolate. Flavor: Brown Sugar Milk, Tea, Undeclared milk, & soy. Size: 1 gallon plastic jar. Lot No. 2106263. Exp. 07/2023

Brand: Etedream. Product: Etegrow ISO. Flavor: Snicker Doodle, Undeclared milk. Size: 2gallon plastic jar. Lot No. 2106002. Exp. 06/2023


Brand: RAW. Product: Vegan Protein Flavor: Peanut Butter, Undeclared coconut. Size: 1gallon plastic jar. Lot No. 2108070, 2104340, 2102018, 2012304, 2010266, 2010102, 2007037/746, 2005132. Exp. 08/2023, 04/2023, 02/2023, 12/2022, 10/2022, 10/2022, 07/2022, 05/2022

Brand: Steel. Product: Veg-Pro Flavor: Cookies & Crème, Undeclared Wheat. Size: 64 ounce plastic jar. Lot No. 2109390, 2104333, 2011260, 2104007/1041, 2105059, 2011260/994. Exp. 09/2023, 04/2023, 11/2022, 04/2023, 05/2023, 11/2022

Brand: Vital Force. Product: PureISO. Flavor: Milk Chocolate, Cocoa, Undeclared milk. Size: 1gallon plastic jar. Lot. No. 2108191. Exp. 09/2023

Brand: Vital Force. Product: PureISO. Flavor: Creamy Peanut, Butter Vanilla, Undeclared milk. Size: 1gallon plastic jar. Lot No. 2109068. Exp. 09/2023

Lot numbers and expiration dates are found on the bottom of each container.

Retailers and distributors who have received any of these products should check inventory, immediately remove from sale and notify customers who purchased them of the recall.

This recall is being made with the knowledge of the Food and Drug Administration.

Company name: Nutracap Holdings, LLC
Brand name: Etedream, Vital Force, Raw, Boba Origin, Steel
Product recalled: Dietary Supplement Protein Powder
Reason of the recall: Undeclared wheat, milk, soy and/or coconut
FDA Recall date: November 09, 2021

Check the full recall details on fda.gov

Source: FDA
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