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Nizatidine Oral Solution 15 mg/mL - recalled due to NDMA (Nitrosodimethylamine) impurity, Bridgewater, New Jersey, USA

April 15, 2020 8:00 PM

Bridgewater Township, New Jersey, United States

Nizatidine Oral Solution 15 mg/mL - recalled due to NDMA (Nitrosodimethylamine) impurity, Bridgewater, New Jersey, USA

Company name: Amneal Pharmaceuticals, LLC
Brand name: Gemini Laboratories
Product recalled: Nizatidine Oral Solution 15 mg/mL
Reason of the recall: NDMA (Nitrosodimethylamine) impurity
FDA Recall date: April 15, 2020
Recall details: Amneal Pharmaceuticals, LLC, Bridgewater, New Jersey is voluntarily recalling three lots of Nizatidine Oral Solution, 15 mg/mL (75 mg/5mL), packaged in 480 mL bottles to the Consumer Level. Nizatidine Oral Solution was distributed by Gemini Laboratories, LLC, a wholly owned subsidiary of Amneal Pharmaceuticals. The three recalled lots are identified in the table below. Nizatidine Oral Solution is being recalled due to potential N-Nitrosodimethylamine (NDMA) amounts exceeding the levels established by the FDA. Risk Statement: NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests.

NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products and vegetables. Amneal Pharmaceuticals, LLC has not received any reports of adverse events that have been confirmed to be directly related to this recall. Nizatidine Oral Solution manufactured by Amneal, is a prescription oral product used for the short-term treatment and maintenance therapy of ulcers and for the treatment of esophagitis and associated heartburn due to gastroesophageal reflux disease (GERD). The Nizatidine Oral Solution lots subject to the recall can be identified by the NDC number and lot number listed on the product label:

- NDC: 60846-301-15. Description: Nizatidine Oral Solution. Lot: 06598004A. Expiration Date: 04/2020
- NDC: 60846-301-15. Description: Nizatidine Oral Solution. Lot: 06599001A. Expiration Date: 12/2020
- NDC: 60846-301-15. Description: Nizatidine Oral Solution. Lot: 06599002A. Expiration Date: 12/2020

The affected Nizatidine Oral Solution lots were distributed directly to wholesalers who further distributed to retail pharmacies and consumers nationwide in the USA. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to the use of this drug product.

Check the full recall details on fda.gov

Source: FDA

Reported By SafelyHQ.com User

Related Reports

August 1, 2020 5:01 PM

“Company name: Laboratorios Jaloma S.A. de C.V.
Brand name: Jaloma
Product recalled: Hand Sanitizer
Reason of the recall: Undeclared Methanol
FDA Recall date: August 01, 2020
Recall details: Company Announcement LABORATORIOS JALOMA S.A. de C.V. is voluntarily recalling all lots and all bottle s ... See Moreizes of the Jaloma Antiseptic Hand Sanitizer, Ethyl Alcohol 62% With vitamin E to the consumer level. This recall has been initiated because FDA sampled the 500 mL product and found it to be contaminated with undeclared methanol (wood alcohol). Although the contamination was linked to the 500 mL product, due to the abundance of caution, Jaloma is recalling all lots of all sizes within expiry. The NDCs, lot #s, and expiration dates are listed in the table below. Risk Statement: Substantial methanol exposure could result in nausea, vomiting, headache, blurred vision, permanent blindness, seizures, coma, and permanent damage to the nervous system or death. Although all persons using these products on their hands are at risk, young children who accidentally ingest these products and adolescents and adults who drink these products as an alcohol (ethanol) substitute, are most at risk for methanol poisoning. To date, LABORATORIOS JALOMA S.A. de C.V. has not received any reports of adverse events related to this recall. Recalled Products
Check the full recall details on fda.gov
Source: FDA
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Reported By SafelyHQ.com User

July 31, 2020 10:01 PM

“Company name: Albek de Mexico S.A. de C.V
Brand name: Nuuxsan, Modesa, Assured, more
Product recalled: Hand Sanitizer
Reason of the recall: Undeclared Methanol
FDA Recall date: July 31, 2020
Recall details: Company Announcement Albek de Mexico S.A. de C.V is voluntarily recalling all lots and ... See Moreall brands of hand sanitizer currently in US distribution to the consumer level. This recall is being initiated out of an abundance of caution due to detection of methanol in hand sanitizer samples manufactured by Albek when product was presented for import into the United States. Risk Statement: Substantial methanol exposure could result in serious health effects (including nausea, diarrhea, vomiting, severe abdominal pain, headache, blurred vision, permanent blindness, seizures, coma, nervous system damage) or death. Persons using methanol-based products on their hands may be at risk. Young children who accidently ingest them and adolescents and adults who drink such products are most at risk for methanol poisoning. To date, there have been no reports of serious adverse events related to the products in the scope of this recall. The products are labeled for use as a hand sanitizer (or “antiseptic”) and are packaged for several nationwide distributors in a variety of formats as indicated in the table as follows:
Check the full recall details on fda.gov
Source: FDA
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Reported By SafelyHQ.com User

July 28, 2020 9:00 PM

“Company name: Broncolin S.A. de C.V
Brand name: Herbacil
Product recalled: Hand Sanitizer
Reason of the recall: Undeclared Methanol
FDA Recall date: July 28, 2020
Recall details: Broncolin S.A. de C.V is voluntarily recalling all lots of Herbacil Antiseptic Hand Sanitizer 70% Alcohol to the co ... See Morensumer level. The products are being recalled due to the potential presence of methanol (wood alcohol).

Risk Statement: Substantial methanol exposure "could result in nausea, vomiting, headache, blurred vision, permanent blindness, seizures, coma, permanent damage to the nervous system or death. Although all persons using these products on their hands are at risk, young children who accidentally ingest these products and adolescents and adults who drink these products as an alcohol (ethanol) substitute, are most at risk for methanol poisoning." To date, Broncolin S.A. de C.V. has not received any reports of adverse events related to the product in question.

The product is an alcohol-based hand sanitizer used to reduce bacteria that potentially cause disease when soap and water are not available and is packaged in 4 bottle sizes; 4.22 fl. oz. (125ml), 8.4 fl. oz. (250 ml), 16.9 fl. oz. (500 ml) and 33.8 fl. oz. (1 Liter). It is a clear plastic bottle with a pump or squeeze cap. All package sizes are labeled with a blue label identifying INBC Trading LLC 4404 Merle Drive, Austin, TX 78745 as the Importer/Distributor (see attachments). Herbacil Antiseptic Hand Sanitizer 70% Alcohol was distributed by the importer/distributor between April 26, 2020 to May 18, 2020 , to wholesalers in Arizona, California, Florida, Georgia, Illinois, Maryland, New Jersey, New York, North Carolina, South Carolina, and Texas and further distributed Nationwide in the USA.

Broncolin S.A. de C.V via INBC Trading LLC is notifying all US customers by email and is arranging for the return of all recalled products. Consumers, distributors, and retailers that have recalled Herbacil hand sanitizer, should stop using and return to the place of purchase. 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.

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

Check the full recall details on fda.gov

Source: FDA
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Reported By SafelyHQ.com User

July 28, 2020 2:00 AM

“Company name: Resource Recovery & Trading, LLC
Brand name: Resource Recover & Trading, LLC
Product recalled: Hand Sanitizer
Reason of the recall: Undeclared Methanol subpotency ethyl alcohol
FDA Recall date: July 27, 2020
Recall details: RESOURCE RECOVERY & TRADING LLC, is voluntarily recalling ... See Moreall the lots manufactured by MXL Comercial S.A. de C.V. of Hand Sanitizer with the next information: HAND SANITIZER 70% Ethyl Alcohol Disinfectant Gel, packaged in 6.7 FL Oz. (200 ml) bottles, UPC 650240026020 and HAND SANITIZER Non-sterile Solution 70% Topical Solution, packaged in 20L (5.28 Gal) liter plastic containers, UPC 37710600013 to the consumer level. The products are being recalled due to the potential presence of undeclared methanol (wood alcohol) and subpotency ethyl alcohol.

Risk Statement: The main concern with the use of hand sanitizer that is sub-potent for ethyl alcohol is the potential for decreased bactericidal and virucidal activity. Adverse health consequences can be related to increased infections. In addition substantial, undeclared methanol exposure, which has inferior antiseptic properties compared to ethanol, can result in nausea, vomiting, headache, blurred vision, permanent blindness, seizures, coma, permanent damage to the nervous system or death. Although all persons using these products on their hands are at risk, young children who accidently ingest these products and adolescents and adults who drink these products as an alcohol (ethanol) substitute, are most at risk for methanol poisoning.

To date, RESOURCE RECOVERY & TRADING LLC has not received any reports of adverse events related to this recall. The product is used as a hand sanitizer to decrease germs when soap and water is not available and is packaged in 200 ml plastic bottles and 20 liter plastic containers. The product can be identified by the label attached. The product was distribution between June 10, 2020 and June 20, 2020 in the states of Alabama and Georgia.

RESOURCE RECOVERY & TRADING LLC is notifying its distributors and customers by phone calls and emails and is arranging for return and destruction of all recalled products. Consumers/distributors/retailers that have product which is being recalled should stop using products, initiate recalls to the user level, and return all products to the place of purchase.

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.

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

Check the full recall details on fda.gov

Source: FDA
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Reported By SafelyHQ.com User

July 27, 2020 6:00 PM

“Company name: 4e Brands North America
Brand name: Assured, Blumen, Modesa
Product recalled: Hand Sanitizer
Reason of the recall: Undeclared Methanol
FDA Recall date: July 27, 2020
Recall details: San Antonio, Texas, 4e Brands North America is voluntarily recalling all lots of Hand Sanitizer bra ... See Morends to the consumer level. These products are being recalled due to the potential presence of methanol (wood alcohol).

Risk Statement: Substantial methanol exposure could result in nausea, vomiting, headache, blurred vision, permanent blindness, seizures, coma, permanent damage to the nervous system or death. Although all persons using these products on their hands are at risk, young children who accidentally ingest these products and adolescents and adults who drink these products as an alcohol (ethanol) substitute, are most at risk for methanol poisoning.

RECALLED PRODUCTS These products are used as hand sanitizers and marketed to help decrease bacteria on the skin when soap and water are not available. This recall now includes all product manufactured by 4e within expiration, regardless of the size, UPC, or lot number. For full details and products click the link below.

Check the full recall details on fda.gov

Source: FDA
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Reported By SafelyHQ.com User

July 24, 2020 8:01 PM

“Company name: Maquiladora Miniara, S.A. de C.V.
Brand name: Shine & Clean
Product recalled: Hand Sanitizer Gel
Reason of the recall: Potential presence of methanol (wood alcohol)
FDA Recall date: July 24, 2020
Recall details: Maquiladora Miniara S.A. de C.V. is voluntarily recalling lots of Shi ... See Morene and Clean Hand Sanitizer gel to the consumer level. The products are being recalled due to the potential presence of methanol (wood alcohol)

Risk Statement: Substantial methanol exposure can result in nausea, vomiting, headache, blurred vision, permanent blindness, seizures, coma, permanent damage to the nervous system or death. Although all persons using these products on their hands are at risk, young children who accidentally ingest these products and adolescents and adults who drink these products as an alcohol (ethanol) substitute, are most at risk for methanol poisoning Maquiladora Miniara S.A. de C.V. has not received any reports of adverse events related to this recall.

These products are used as topical hand sanitizers. The affected Shine and Clean Hand Sanitizer Gel is packaged in 1000 ml bottles and 1-gallon containers. Shine and Clean Hand Sanitizer gel were distributed Nationwide to retail stores via distributors. Lot numbers:

F200829088/F200829095/F200829107/D202728743/D202528742/D202428733/D202728743/
D2028753/D202528742/D202428733/ D202028689/ D201828660/D202428734/
E200128784/E200418795/D202428734/D202828689/D201828660/E201628912/E201628913/
E201628911/E201528902/E201528903/E201628910/E201628918/E201628914/E201628915/
E201628916/E201628917/ E202328969/E202428975/ E202528981 /E202128947/E201728918/
E201728919/E201428876/ E201828894/E201828920/E201428876/E201128850/E201328859/
E200628817/E200828826/E200928840/D202128699/D202428700.

Maquiladora Miniara S.A. de C.V. is notifying its distributors and customers by e-mail and is arranging for return of all recalled products. Distributors that have Shine and Clean Hand Sanitizer which is being recalled, should stop using and distributing product and contact their clients.

Consumers who have questions about this recall can contact Maquiladora Miniara S.A. de C.V. By +52 55 33871987 + 52 55 8394 5857 the hours are available from 10:00 a.m. to 1:00 p.m. and from 2:00 p.m. to 4:00 p.m. Consumers should contact their doctor or healthcare provider if they have experienced any problems related to taking or using this medicine.

Check the full recall details on fda.gov

Source: FDA
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Reported By SafelyHQ.com User

July 24, 2020 12:00 PM

“Company name: Real Clean Distribuciones SA de CV
Brand name: Born Basic, Scent Theory and more
Product recalled: Hand Sanitizer
Reason of the recall: Undeclared methanol
FDA Recall date: July 24, 2020
Recall details: La Loma, Tlalnepantla, Mexico, Real Clean Distribuciones SA de CV is voluntari ... See Morely recalling all lots it manufactured within expiry of the following brand names of hand sanitizers:
- Born Basic ANTI-BAC HAND SANITIZER
- Scent Theory KEEP CLEAN Moisturizing Hand Sanitizer
- Scent Theory KEEP IT CLEAN Moisturizing Hand Sanitizer
- Lux Eoi Hand Sanitizing Gel to the consumer level.

The products are being recalled due to the potential presence of methanol (wood alcohol).

Risk Statement: Substantial methanol exposure could result in nausea, vomiting, headache, blurred vision, permanent blindness, seizures, coma, permanent damage to the nervous system or death.

Although all persons using these products on their hands are at risk, young children who accidentally ingest these products and adolescents and adults who drink these products as an alcohol (ethanol) substitute, are most at risk for methanol poisoning. To date, Real Clean Distribuciones SA de CV has not received reports of adverse events related to this recall.

RECALLED PRODUCTS These products are used as hand sanitizers and marketed to help decrease bacteria on the skin when soap and water are not available. Real Clean Distribuciones SA de CV manufacturers product for four brands included in this recall. Scent Theory and Born Basic hand sanitizer products are produced by several different manufacturers, in several different countries, and only those lots manufactured by Real Clean in Mexico are subject to the recall. The recalled products include the following lots:

Manufacturer: Real Clean Distribuciones S.A. De C.V
Product: Scent Theory Keep Clean Hand Sanitizer 70% Alcohol
Country of Origin: Mexico
Size: 16.9oz
Lot Numbers: 1633220, 1733220, 1833220, 1933220, 2033220, 2133220, 2233220, 2333220, 2433220, 2533220, 2633220, 2733220, 2833220, 2933220, 3033220, 3133220, 3233220, 3333220, 3433220, 3533220, 3633220, 3733220, 3833220, 3933220, 4033220, 4133220

Manufacturer: Real Clean Distribuciones S.A. De C.V
Product: Keep it Clean Hand Sanitizer 70% Alcohol
Country of Origin: Mexico
Size: 16.9oz
Lot Numbers: 0133220, 0233220, 0333220, 0433220, 0533220, 0633220, 0733220, 0833220, 0933220, 1033220 1133220, 1233220, 1333220, 1433220, 1533220

Manufacturer: Real Clean Distribuciones S.A. De C.V
Product: Born Basic Anti-Bac Hand Sanitizer 70% Alcohol
Country of Origin: Mexico
Size: 16.9oz
Lot Numbers: 0833420, 0933420, 1033420, 1133420, 1233420, 1333420, 1433420, 1533420, 1633420, 1733420, 1833420, 1933420, 2033420, 2133420, 2233420, 2333420, 2433420, 2533420, 2633420, 2733420, 2833420, 2933420

Manufacturer: Real Clean Distribuciones S.A. De C.V
Product: Born Basic Anti-Bac Hand Sanitizer 70% Alcohol
Country of Origin: Mexico
Size: 34oz
Lot Numbers: 0133420, 0233420, 0333420, 0433420, 0533420, 0633420

Manufacturer: Real Clean Distribuciones S.A. De C.V
Product: Born Basic Anti-Bac Hand Sanitizer 70% Alcohol
Country of Origin: Mexico
Size: 9.5oz
Lot Numbers: 0133720, 0233720

Manufacturer: Real Clean Distribuciones S.A. De C.V
Product: Lux Eoi Hand Sanitizing Gel
Country of Origin: Mexico
Size: 16.9oz
Lot Numbers: 0133920, 0233920, 0333920

Real Clean Distribuciones SA de CV is notifying its distributors by recall letter and consumers via this press release. Real Clean Distribuciones SA de CV is arranging for the return and refund of all recalled products.

Consumers/distributors/retailers that have the product subject to this recall should stop using/distributing/selling Hand Sanitizer and return it to the place of purchase; because the affected products are considered hazardous materials, do not destroy the affected products.

Check the full recall details on fda.gov

Source: FDA
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Reported By SafelyHQ.com User

July 22, 2020 6:01 PM

“Company name: Fresenius Kabi USA
Brand name: Fresenius Kabi
Product recalled: Dexmedetomidine Hydrochloride Injection, 200 mcg/50 mL
Reason of the recall: Cross contamination with lidocaine
FDA Recall date: July 22, 2020
Recall details: Fresenius Kabi USA is voluntarily recalling two lots of De ... See Morexmedetomidine HCl in 0.9% Sodium Chloride Injection, 200 mcg/50 mL (4 mcg / mL), 50 mL fill in a 50 mL vial. Fresenius Kabi initiated this recall due to the possibility of a trace amount of lidocaine present in these two lots and our investigation indicates that this issue is limited to these two product lots. This recall is being performed to the user level.

To date, no adverse drug experience reports have been received for either of the lots being recalled by Fresenius Kabi. Administration of Dexmedetomidine HCl containing trace amounts of lidocaine to a patient with lidocaine allergy, however, could result in anaphylaxis, a potentially life-threatening condition. Dexmedetomidine Hydrochloride in 0.9% Sodium Chloride Injection is approved for intravenous use and indicated for sedation of non-intubated patients prior to and/or during surgical and other procedures. Below there is a list of the recalled lots distributed nationwide to wholesalers, distributors, hospitals, and pharmacies between June 3, 2019 and April 8, 2020, as well as a copy of the label:

Product Name/Product size: Dexmedetomidine HCl in 0.9% Sodium Chloride Injection, 200 mcg / 50 mL (4 mcg / mL), 50 mL fill in a 50 mL vial
NDC Number: 63323-671-50
Product Code: 671050
Batch Number: 6121853 - 6122207
Expiration Date: 05/2021 - 06/2021
First Ship Date 06/03/2019 - 12/04/2019
Last Ship Date: 03/12/2020 - 04/08/2020

Fresenius Kabi is notifying its distributors and customers by letter and asking customers and distributors to check their stock immediately and to quarantine and discontinue the use and distribution of any affected product.

Distributors should notify their customers and direct them to quarantine and discontinue distributing or dispensing any affected lots, and to return the product to Fresenius Kabi.

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

Check the full recall details on fda.gov

Source: FDA
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Reported By SafelyHQ.com User

July 20, 2020 6:01 PM

“Company name: LIQ-E S.A. de C.V.
Brand name: Optimus
Product recalled: Hand Sanitizer
Reason of the recall: Potential Methanol Contamination
FDA Recall date: July 20, 2020
Recall details: SAN NICOLAS DE LOS GARZA, Mexico -- LIQ-E S.A. de C.V. is voluntarily recalling all lots and all bottle s ... See Moreizes of The OPTIMUS Instant Hand Sanitizer due to the potential presence of methanol (wood alcohol) that were shipped into the United States. The products were manufactured between April 27, 2020 and May 08, 2020. Risk Statement: Substantial methanol exposure could result in nausea, vomiting, headache, blurred vision, permanent blindness, seizures, coma, and permanent damage to the nervous system or death. Although all persons using these products on their hands are at risk, young children who accidentally ingest these products and adolescents and adults who drink these products as an alcohol (ethanol) substitute, are most at risk for methanol poisoning. To date, LIQ-E S.A. de C.V. has not received any reports of adverse events related to this recall.

Recalled Products: Optimus Instant Hand Sanitizer
Product(s) NDCs: 75416-002-01
Sizes: 8.5Fl Oz.(250 mL)
UPC: 7501799115621
Lot #s & Expiration Dates: (L) 20-02 EXP 05/2022

Recalled Products: Optimus Instant Hand Sanitizer
Product(s) NDCs: 75416-001-04
Sizes: 55 Gal (208 L)
UPC: 7501799118998
Lot #s & Expiration Dates: See List

Recalled Products: Optimus Instant Hand Sanitizer
Product(s) NDCs: 75416-378-04
Sizes: 1 GAL (3.78L)
UPC: 7501799118837
Lot #s & Expiration Dates: (L) 20-03 EXP 05/22

Recalled Products: Optimus Instant Hand Sanitizer
Product(s) NDCs: 75416-004-01
Sizes: 275 Gal (1,040 L)
UPC: 7501799118981
Lot #s & Expiration Dates: (L) 5200 EXP 05/2022

55 Gal Blue Drum Lot Numbers: L-1160 EXP 05/2022 ; L-2160 EXP 05/2022 ; L-3160 EXP 05/2022 ; L-1180 EXP 05/2022 ; L-2180 EXP 05/2022 ; L-2190 EXP 05/2022 ; L-1200 EXP 06/2022 ; L-2200 EXP 06/2022 ; L-3200 EXP 06/2022 ; L-4200 EXP 06/2022 ; L-5200 EXP 06/2022 ; L-1210 EXP 06/2022 L-2210 EXP 06/2022

Master Cartons Lot Numbers:
L-1150 L-2150 L-3150 L-4150 L-5150 L-6150
L-1160 L-2160 L-3160 L-4160 L-5160 L-6160
L-1170 L-2170 L-3170 L-4170 L-5170 L-1180
L-3180 L-4180 L-6180 L-1190 L-2190 L-3190
L-4190 L-5190 L-6190 L-1200 L-2200 L-3200
L-4200 L-5200 L-6200 L-2180

The Hand Sanitizer is distributed in a 55 Gal (208 L) plastic blue drum and in 8.5Fl Oz. (250 mL), 1Gal (3.78 L), and 275 Gal (1,040L) clear plastic HDPE bottles or tank. All are labeled with a green and white label. The product was distributed throughout the United States.

Each product contains a lot number consisting of a letter followed by a dash four digits (example L-1180). This number can be found on the master cartons and written in black pen on the 55 Gal blue drum and the 275 Gal plastic tank.

The individual bottles are labeled with a lot number and expiration date in the format below. See table for lot numbers of each individual bottle.

(L) 20-02 EXP 05/2022

Check the full recall details on fda.gov

Source: FDA
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Reported By SafelyHQ.com User

July 18, 2020 12:37 AM

“Company name: InHE Manufacturing, LLC
Brand name: Multiple brand names
Product recalled: Hemp Oil Tinctures
Reason of the recall: Excess lead in product
FDA Recall date: July 17, 2020
Recall details: Company Announcement This recall press release was issued by the firm on 06-23-2020 and is subs ... See Moreequently being posted by FDA at this time only to benefit the public for informational purposes.

Human Consumption (MHR Brands):

- Tasty Drops – Berry Tincture, 1oz/300mg FG003175

- Tasty Drops – Berry Tincture, 1oz/500mg FG003137 FG003174, FG003197, FG0057

- Tasty Drops – Berry Tincture, 1oz/1500mg FG003141, FG003202, FG003296

- Tasty Drops – Natural Tincture, 1oz/500mg FG003138, FG003248

- Tasty Drops – Natural Tincture, 1oz/1500mg FG003142, FG003247

- Tasty Drops – Spearmint Tincture, 1oz/300mg FG003167

- Tasty Drops – Spearmint Tincture, 1oz/500mg FG003139, FG003166, FG003191, FG003225, FG003253, FG003263

- Tasty Drops – Spearmint Tincture, 1oz/1000mg FG003095

- Tasty Drops – Spearmint Tincture, 1oz/1500mg FG003143, FG003180, FG003201, FG003224, FG003262

- Tasty Drops – Vanilla Tincture, 1oz/300mg FG003126

- Tasty Drops – Vanilla Tincture, 1oz/500mg FG003140, FG003182, FG003246

- Tasty Drops – Vanilla Tincture, 1oz/1500mg FG003144, FG003249

- Made by Hemp – French Vanilla Tincture, 1oz/1000mg FG003107

- Made by Hemp – Mojito Lime Tincture, 1oz/1000mg FG003110

- Made by Hemp – Strawberry Crème Tincture, 1oz/1000mg FG003109

Pet Consumption (White Label)

- Herbal Renewals – Cat Tincture, 1oz/200mg FG003213

- Herbal Renewals – Pet Blend, 1oz/200mg FG003223, FG003310

- Barkley Bistro – Dog Tincture, 1oz/200mg FG003145

- A Clean Choice – Cat Tincture, 1oz/200mg FG003117

- A Clean Choice – Cat Tincture, 500mg/1oz FG003118

- A Clean Choice – Dog Tincture, 1oz/200mg FG003116

- A Clean Choice – Dog Tincture, 500mg/1oz FG003115

- BC Hemp Co LLC – Pet Tincture, 1oz/200mg FG003165

- Boost IV Hydration, LLC – Dog Tincture, 1oz/200mg FG003270

- Acadia Farms – Pet Blend, 1oz/200mg FG003176

How the company learned of this situation: The Company was recently advised by the Florida Department of Health of the presence of elevated heavy metals (lead) in some of its products.

Exposure to lead could present physical signs and symptoms including, pain, paresthesia/muscle weakness, abdominal pain, nausea, vomiting, diarrhea, constipation, poor appetite, weight loss, symptoms associated with encephalitis, metallic taste in the mouth, shock, hemolysis or kidney damage.

Consumers should contact their physician or healthcare provider if they experience any symptoms that may be related to using the products being recalled. Consumers should observe pets and contact their veterinarian as signs and symptoms of lead exposure in pets may be similar to those in humans.

Check the full recall details on fda.gov

Source: FDA
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Reported By SafelyHQ.com User

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Reason of the recall: Due to elevated level of Rumensin ... See More(monensin)
FDA Recall date: May 29, 2020
Recall details: PGG/HSC Feed Company, LLC, dba CHS Nutrition of Hermiston, Oregon, is recalling 510 bags (50 lbs. each) of Champion Meat Goat Pellets R20, Medicated Feed due to elevated level of Rumensin (monensin). Monensin is an FDA-approved drug for use in certain animal feeds. However, if the feed contains excessive amounts, the feed can cause monensin toxicity in a number of animal species including goats. Goats ingesting excessive levels of monensin in feed are susceptible to injury and death. In goats, signs and symptoms can include bloated stomach, bloody urine, shortness of breath, muscle weakness or cramps, rapid breathing and death. In humans, monensin could affect handlers of highly concentrated products by causing irritation of the skin, eyes, and respiratory tract through direct exposure.

People or animals who consume meat or milk from animals exposed to very high levels of monensin are at risk of indirect exposure, which could potentially lead to ingestion toxicity.   Champion Meat Goat Pellets R20, Medicated Feed, was distributed to three consignees in Oregon and Washington between April 20, 2020, and April 29, 2020. NW Farm Supply in Hermiston, Oregon and in Prosser, Washington, further sold the recalled product to downstream customers.

The recalled product is pelleted dry feed and bagged in poly bags with the words Payback Champion Feeds printed on the bag. Each bag weighs 50 lbs. The affected lot number 6705 HM928510 04/17/20 and the UPC code 48252 48640 are printed on the tag of each bag. Customers reported that three goats have died, and three additional goats were ill but have recovered to date. The recalled product was found to contain elevated levels of monensin due to a mixing error during manufacturing. The recalled product was put on hold pending testing after a customer complaint. Test results confirmed a higher than expected level and this recall was initiated. CHS Nutrition cannot account for up to 15 bags out of 510 bags distributed to date.

Check the full recall details on fda.gov

Source: FDA
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Reported By SafelyHQ.com User

July 2, 2020 9:00 PM

“Company name: Transliquid Technologies LLC
Brand name: Mystic Shield
Product recalled: Mystic Shield Protection Topical Solution
Reason of the recall: Undeclared methanol
FDA Recall date: July 02, 2020
Recall details: Company Announcement Transliquid Technologies LLC is voluntarily recalling al ... See Morel Mystic Shield Protection Topical Solution, manufactured by Mystic Intl S.A. de C.V in Mexico City, and packaged in an 8.45 ounce (250 ml) bottles, to the consumer level. The firm’s independent testing found the products contain undeclared methanol. Risk Statement: Substantial methanol exposure “could result in nausea, vomiting, headache, blurred vision, permanent blindness, seizures, coma, permanent damage to the nervous system or death. Although all persons using these products on their hands are at risk, young children who accidentally ingest these products and adolescents and adults who drink these products as an alcohol (ethanol) substitute, are most at risk for methanol poisoning.”

To date, Transliquid Technologies LLC has not received any reports of adverse events related to the product in question. The product is an alcohol-based hand sanitizer used to reduce bacteria that potentially cause disease when soap and water are not available and is packaged in an 8.45 ounce (250 ml) blue or green labeled bottle with a white or transparent cap and bears a green or blue label identifying Mystic Shield Protection. The product was distributed between May 21, 2020-June 30, 2020 to select wholesale and retail customers in California, Louisiana, Massachusetts, and Texas.

Transliquid Technologies LLC has accounted for and prevented distribution of a substantial majority of the product at the consumer level and is arranging for its return. Transliquid Technologies LLC is notifying its distributors and customers by email and first-class U.S. Mail and is arranging for the return of all recalled products. Consumers, distributors, and retailers that have Mystic Shield Protection hand sanitizer, which is being recalled, should stop using and return to the place of purchase. 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.

Check the full recall details on fda.gov

Source: FDA
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Reported By SafelyHQ.com User

April 12, 2020 12:00 PM

“Details:
An employee at the Schnucks in Ladue has tested positive for COVID-19. The employee had not been to work since April 2 and is now quarantined at home.

The store is now open to customers after the deep cleaning.

Report: 3/27/2020
Source: ... See More>kmov.com See Less
Reported By SafelyHQ.com User

June 15, 2020 2:43 PM

“Bone fragment in Carl Budding meat packets. Mixed chicken and ... See Moreom/product/honey#scroll" title="Product: Honey">honey ham so not sure which one. See Less
Reported By SafelyHQ.com User

Droppings of a rat or mouse, Chipotle Mexican Grill, 53rd St, Chicago, IL 60615, United States

Chipotle Mexican Grill, 53rd St, Chicago, IL 60615, United States

July 27, 2020 12:17 AM

“I ordered a bowl and I seen like the Droppings of a rat or mouse in there plus maybe the anus cut up with some still stuck in there . See Less
Reported By SafelyHQ.com User

April 15, 2020 8:00 PM

“Company name: Amneal Pharmaceuticals, LLC
Brand name: Gemini Laboratories
Product recalled: Nizatidine Oral Solution 15 mg/mL
Reason of the recall: NDMA (Nitrosodimethylamine) impurity
FDA Recall date: April 15, 2020
Recall details: Amneal Pharmaceuticals, LLC, Bridgewater, New Jersey is volunt ... See Morearily recalling three lots of Nizatidine Oral Solution, 15 mg/mL (75 mg/5mL), packaged in 480 mL bottles to the Consumer Level. Nizatidine Oral Solution was distributed by Gemini Laboratories, LLC, a wholly owned subsidiary of Amneal Pharmaceuticals. The three recalled lots are identified in the table below. Nizatidine Oral Solution is being recalled due to potential N-Nitrosodimethylamine (NDMA) amounts exceeding the levels established by the FDA. Risk Statement: NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests.

NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products and vegetables. Amneal Pharmaceuticals, LLC has not received any reports of adverse events that have been confirmed to be directly related to this recall. Nizatidine Oral Solution manufactured by Amneal, is a prescription oral product used for the short-term treatment and maintenance therapy of ulcers and for the treatment of esophagitis and associated heartburn due to gastroesophageal reflux disease (GERD). The Nizatidine Oral Solution lots subject to the recall can be identified by the NDC number and lot number listed on the product label:

- NDC: 60846-301-15. Description: Nizatidine Oral Solution. Lot: 06598004A. Expiration Date: 04/2020
- NDC: 60846-301-15. Description: Nizatidine Oral Solution. Lot: 06599001A. Expiration Date: 12/2020
- NDC: 60846-301-15. Description: Nizatidine Oral Solution. Lot: 06599002A. Expiration Date: 12/2020

The affected Nizatidine Oral Solution lots were distributed directly to wholesalers who further distributed to retail pharmacies and consumers nationwide in the USA. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to the use of this drug product.

Check the full recall details on fda.gov

Source: FDA
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Reported By SafelyHQ.com User

July 30, 2020 11:37 AM

“I feel like I've been cordial enough. Unfortunately, their response hasn't been.
They serves undercooked food. See Less
Reported By SafelyHQ.com User

June 29, 2020 7:47 AM

“Found piece of Plastic in Whole Foods Icecream. Reported the issue to Whole Foods on Jun 7th, but not sure if they are making any effort to recall the product.
UPC: 099482478209
Batch or lot code: 12-25-2020
Product name: 365 Everyday value, ... See More/chocolate#scroll" title="Product: Chocolate">Chocolate Valencia Orange Icecream See Less
Reported By SafelyHQ.com User

I had allergic type reactions after eating pineapple, Giant Eagle Bakery, Pearl Road, Strongsville, Ohio, USA

Symptoms: Headache
Giant Eagle Bakery, Pearl Road, Strongsville, Ohio, USA

July 16, 2020 5:01 PM

“I ate pineapple and within 30 minutes I had allergic type reactions. Burning lips, swollen tongue with bumps, severe headache. No vomiting, no diarrhea. Still have severe headaches. See Less
Reported By SafelyHQ.com User