Category: Drugs

Summary

Company Announcement Date:
FDA Publish Date:
Product Type:
Drugs
Reason for Announcement:
Due to the Detection of N-Nitrosodimethylamine (NDMA) Impurity
Company Name:
Sun Pharmaceutical Industries
Brand Name:
Riomet ER
Product Description:
Metformin Hydrochloride for Extended-Release Oral Suspension

Company Announcement

Sun Pharmaceutical Industries, Inc. (SUN PHARMA), a wholly owned subsidiary of Sun Pharmaceutical Industries Ltd. is voluntarily recalling one lot of RIOMET ER™ (metformin hydrochloride for extended-release oral suspension), 500 mg per 5 mL to the consumer level.  The reason for the recall is due to the level of N-Nitrosodimethylamine (NDMA), which has been found to be above the allowable Acceptable Daily Intake (ADI) limit established by the U.S. Food and Drug Administration.

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.  To date, SUN PHARMA has not received any reports of adverse events related to this recall. (more…)

Summary

Company Announcement Date:
FDA Publish Date:
Product Type:
Drugs
Reason for Announcement:
Sub Potency
Company Name:
Acella Pharmaceuticals, LLC
Brand Name:
NP Thyroid 15 & NP Thyroid120
Product Description:
Thyroid Tablets

Company Announcement

Acella Pharmaceuticals, LLC is voluntarily recalling one lot of 15-mg and one lot of 120-mg NP Thyroid®, Thyroid Tablets, USP [levothyroxine (T4) and liothyronine (T3)] to the consumer level. The products are being recalled because testing has found these lots to be sub potent. The product may have as low as 87% of the labeled amount of levothyroxine (T4). More information can be found at www.npthyroid.com/product-updatesExternal Link Disclaimer.

Risk Statement: Patients being treated for hypothyroidism (underactive thyroid), who receive sub potent NP Thyroid®, may experience signs and symptoms of hypothyroidism (underactive thyroid) which may include, fatigue, increased sensitivity to cold, constipation, dry skin, puffy face, hair loss, slow heart rate, depression, swelling of the thyroid gland and/or unexplained weight gain or difficulty losing weight. There is reasonable risk of serious injury in newborn infants or pregnant women with hypothyroidism including early miscarriage, fetal hyperthyroidism, and/or impairments to fetal neural and skeletal development. In elderly patients and patients with underlying cardiac disease toxic cardiac manifestations of hyperthyroidism may occur, such as cardiac pain, palpitations or cardiac arrhythmia. To date, Acella has received four reports of adverse events for these lot numbers possibly related to this recall. (more…)

Summary

Company Announcement Date:
FDA Publish Date:
Product Type:
Drugs
Reason for Announcement:
Contains Methanol and may be Sub-Potent for Ethanol
Company Name:
Medek, LLC
Brand Name:
M
Product Description:
M Hand Sanitizer Alcohol Antiseptic 80%

Company Announcement

Medek, LLC is voluntarily recalling all lots of M Hand Sanitizer Alcohol Antiseptic 80% 128 oz/3,785 mL to the consumer level. FDA analysis found the M Hand Sanitizer to contain methanol and be sub-potent for ethanol.

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 accidently ingest these products and adolescents and adults who drink these products as an alcohol (ethanol) substitute, are most at risk for methanol poisoning. In addition, the use of sub-potent hand sanitizer products can have adverse health consequences related to lack of efficacy and increased risk of infections. To date, Medek, LLC. has not received any reports of adverse. (more…)

Summary

Company Announcement Date:
FDA Publish Date:
Product Type:
Drugs
Reason for Announcement:
Possible presence of methanol
Company Name:
AJR Trading LLC
Brand Name:
bio aaa
Product Description:
Hand Sanitizer

Company Announcement

AJR Trading is voluntarily recalling 2,004 units of lot 20DF8307 of bio aaa Advance Hand Sanitizer currently in US distribution, packaged in 480 mL bottles, to the consumer level.

This lot of bio aaa Advance Hand Sanitizer has been tested and meets all appropriate specifications and tests.

However, in an abundance of caution, these units are being recalled because of possible presence of methanol in other lots of bio aaa Advance Hand Sanitizer.

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 may be at risk; young children who accidently ingest them and adolescents and adults who drink these products as an alcohol (ethanol) substitute, are most at risk for methanol poisoning.

To date, AJR Trading has not received reports of adverse events related to this recall. (more…)

Summary

Company Announcement Date:
FDA Publish Date:
Product Type:
Drugs
Reason for Announcement:
Product may be sub potent
Company Name:
RLC Labs, Inc
Brand Name:
RLC Labs
Product Description:
Nature-Throid® and WP Thyroid®

Company Announcement

RLC Labs, Inc. is voluntarily recalling a total of 483 lots of Nature-Throid® and WP Thyroid® in all strengths, all counts of product within current expiry to the consumer level. The products are being recalled because testing of samples from  six (6) lots  by the U.S. Food and Drug Administration found the samples to be sub potent. The product may have as low as 87% of the labeled amount of Liothyronine (T3) or Levothyroxine(T4).

Risk Statement: Patients being treated for hypothyroidism (underactive thyroid), who receive sub potent Nature-Throid® or WP Thyroid®, may experience signs and symptoms of hypothyroidism (underactive thyroid) which may include, fatigue, increased sensitivity to cold, constipation, dry skin, puffy face, hair loss, slow heart rate, depression, swelling of the thyroid gland and/or unexplained weight gain or difficulty losing weight. There is reasonable risk of serious injury in newborn infants or pregnant women with hypothyroidism including early miscarriage, fetal hyperthyroidism, and/or impairments to fetal neural and skeletal development. In elderly patients and patients with underlying cardiac disease toxic cardiac manifestations of hyperthyroidism may occur, such as cardiac pain, palpitations or cardiac arrhythmia. RLC Labs, Inc. has not received any reports of adverse events related to this recall. (more…)

Summary

Company Announcement Date:
FDA Publish Date:
Product Type:
Drugs
Reason for Announcement:
Product is labeled as edible alcohol.
Company Name:
CorgioMed LLC
Brand Name:
Leafree
Product Description:
Hand sanitizer

Company Announcement

CorgioMed, LLC is voluntarily recalling all lots of Leafree Instant Hand Sanitizer-Aloe Vera, within expiry to the consumer level.  The products are being recalled because they are labeled as “EDIBLE ALCOHOL”. Leafree Hand Sanitizer is an alcohol-based hand rub to be applied externally to reduce bacteria on the skin when soap and water are not available.

Risk Statement: Ingesting hand sanitizer, which is intended for topical use, may 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. Young children may experience a sharp decrease in blood sugar which may result in death. Pregnant women who ingest alcohol have experienced birth defects and developmental disabilities. Nursing mothers who ingest alcohol in above moderate levels may see developmental, growth and sleep pattern damages in their babies and may experience impaired judgement and ability to safely care for their child. 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.  The labeling of this product as ‘edible alcohol’ may promote this behavior. (more…)

Name of product:
31 Medique Over-the-Counter drugs from the product lines: Medi-First, Medi-First Plus, Medique, Dover, Otis Clapp, and Ecolab.
Hazard:

The over-the-counter products contain regulated substances which must be in child resistant packaging when being used in the household as required by the Poison Prevention Packaging Act (PPPA).  The packaging of the products is not child resistant, posing a risk of poisoning if the contents are swallowed by young children.

Remedy:
Refund
Recall date:
September 11, 2020
Units:
About 143,300
Consumer Contact:

Medique at 800-680-2474 from 8 a.m. to 7 p.m. ET, Monday through Friday, or online at www.mediqueproducts.com and click on “Recall Notice” at the bottom of the page for more information including registration access.

Recall Details

Description:

The recall involves 31 different over-the-counter drugs purchased on or after June 1, 2018 that are unexpired from the following brands:  Medi-First, Medi-First Plus, Medique, Dover, Otis Clapp, and Ecolab.  They include aspirin-containing products, acetaminophen-containing products, ibuprofen-containing products, lidocaine-containing products, diphenhydramine, loperamide, and naproxen products.  The expiration date for tablets and creams can be found on either the top or side panels of the container carton in the format [YEAR/MO].  For products in spray bottles, the expiration date in the same format is located on the front of the bottle.  The expiration date is found on the bottom for the spray cans.  The 31 different recalled products are listed in the table below:

Product

Drug

Package Type

# of Packets

Medi-First Non-Aspirin Acetaminophen

acetaminophen (325 mg)

2 tablets packet

50

250

Medi-First Extra Strength Non-Aspirin Acetaminophen

acetaminophen (500 mg)

2 tablets packet

50

125

250

Medi-First Sinus Pain & Pressure

acetaminophen (500 mg)

2 tablets packet

50

125

250

Medique APAP

acetaminophen (325 mg)

2 tablets packet

250

Medique Extra Strength APAP

acetaminophen (500 mg)

2 tablets packet

50

125

250

Medique Back Pain-Off

acetaminophen (250 mg)

2 tablets packet

50

100

250

Medique CCP Caffeine Fee

acetaminophen (325 mg)

2 tablets packet

50

250

Medi-First Cold Relief

acetaminophen (325 mg)

2 tablets packet

50

125

250

Medique Cramp Tabs

acetaminophen (325 mg)

2 tablets packet

50

125

250

Medique Decorel Forte Plus

acetaminophen (325 mg)

2 tablets packet

50

250

Medique Medicidin-D

acetaminophen (325 mg)

2 tablets packet

50

100

250

Dover Aminofen

acetaminophen (325 mg)

2 tablets packet

250

Otis Clapp Back Quell

acetaminophen (200 mg)

2 tablets packet

150

Otis Clapp Mygrex

acetaminophen (500 mg)

2 tablets packet

150

Otis Clapp Valihist

acetaminophen (325 mg)

2 tablets packet

150

Medi-First Pain Relief Extra Strength

acetaminophen (110 mg)
aspirin (162 mg)

2 tablets packet

50

100

250

Medi-First Plus Pain Zappers

acetaminophen (250 mg)
aspirin (250 mg)

2 tablets packet

50

125

Medique Pain-Off

acetaminophen (250 mg)
aspirin (250 mg)

2 tablets packet

50

100

250

Medi-First Aspirin

aspirin (325 mg)

2 tablets packet

50

125

250

Medi-First Plus Aspirin

aspirin (325 mg)

2 tablets packet

50

125

Medique Aspirin

aspirin (325 mg)

2 tablets packet

12

100

250

Medique Diphen

diphenhydramine (25 mg)

1 tablet packet

24

200

Medi-First Ibuprofen

ibuprofen (200 mg)

2 tablets packet

4

50

125

250

Medique I-Prin

ibuprofen (200 mg)

2 tablets packet

3

100

250

Dover Addaprin

ibuprofen (200 mg)

2 tablets packet

250

Medi-First Burn Cream with Lidocaine

lidocaine (0.9 grams)

packets

25

Medi-First Burn Spray

lidocaine HCl (2%)

2 oz bottle

Medi-First Blood Clotting Spray

lidocaine (4%)

3 oz bottle

Ecolab Burn Cream

lidocaine (0.9 grams)

packets

25

Medique Diamode

loperamide HCl (2 mg)

1 tablet packet

6

50

100

Medique Mediproxen

naproxen sodium (220 mg)

1 tablet packet

50

100

Remedy:

Consumers should immediately store the recalled products in a safe location out of reach of children and contact Medique for information on how to dispose of the product and receive a full refund.  All known purchasers are being notified directly.

Incidents/Injuries:

None reported. (more…)

Summary

Company Announcement Date:
FDA Publish Date:
Product Type:
Drugs
Reason for Announcement:
Product contains undeclared sildenafil
Company Name:
The Protein Shoppe, LLC
Brand Name:
Red-E
Product Description:
Red-E male enhancement tablet

Company Announcement

The Protein Shoppe, LLC is voluntarily recalling all lots of “Red-E” (Male Enhancement tablet) to the consumer level. This recall has been initiated after an FDA laboratory analysis found the product to contain undeclared sildenafil, a Phosphodiesterase-5 (PDE-5) inhibitor which is the active ingredient in an FDA approved drug used in the treatment of erectile dysfunction. The presence of sildenafil in Red-E renders it an unapproved drug for which safety and efficacy have not been established and, therefore, subject to recall.

The undeclared PDE-5 inhibitor in the product may pose serious health risks to consumers with underlying medical issues. For example, PDE-5 inhibitors may interact with nitrates found in some prescription drugs (such as nitroglycerin) lowering blood pressure to dangerous levels that is life threatening and could result in serious adverse health consequences. Consumers with diabetes, high blood pressure, or heart disease often take nitrates. To date The Protein Shoppe, LLC has not received any reports of adverse events related to this recall. (more…)

Summary

Company Announcement Date:
FDA Publish Date:
Product Type:
Drugs
Reason for Announcement:
Products labeled to contain methanol
Company Name:
Open Book Extracts
Brand Name:
Always Be Clean, Just
Product Description:
Hand Sanitizer

Company Announcement

Open Book Extracts (OBX) is voluntarily recalling to the consumer level all lots of Always Be Clean Hand Sanitizer and Just Hand Sanitizer that are labeled to contain methanol.

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. (more…)

Summary

Company Announcement Date:
FDA Publish Date:
Product Type:
Drugs
Reason for Announcement:
Product contains 1-propanol.
Company Name:
Nanomateriales, SA de CV
Brand Name:
Zanilast+
Product Description:
Hand sanitizer

Company Announcement

Apodaca, Nuevo Leon, Nanomateriales is voluntarily recalling all lots of ZANILAST+ GEL, Sanitizer gel, to the consumer level. FDA laboratory analysis found ZANILAST+ GEL to contain 1-propanol.

Risk Statement: There is a reasonable probability of acute toxicity from ingestion which can cause central nervous system depression, which could result in death, permanent impairment, or necessitate medical or surgical intervention. Populations most at risk include individual with alcohol addiction and adolescents, who have been known to ingest ethanol-based antiseptic rubs intentionally to become intoxicated, as well as infants and children who may unintentionally ingest the defective product. Nanomateriales, SA de CV has not received any reports of adverse events related to this recall. (more…)