Marksans Pharma Limited Metformin
Marksans is voluntarily expanding an earlier Metformin recall to include more products that may contain NDMA – a probable human carcinogen. The new recall includes 76 batches of Metformin Hydrochloride Extended-Release Tablets USP. The recall includes both 500 mg and 750 mg tablets. Patients taking drugs contaminated with NDMA may be at an increased risk of developing certain types of cancer.
Acella Pharmaceuticals NP Thyroid Tablets
Acella Pharmaceuticals is voluntarily recalling two lots of NP Thyroid 15 and NP Thyroid 120 tablets. The recall stems from tests that showed the tablets contained around 87% of the amount of T4 hormone (levothyroxine) listed on the label. The sub potent drugs could cause serious side effects in patients.
RLC Labs Nature-Throid and WP Thyroid
RLC Labs, Inc. is recalling 483 lots of Nature-Throid and WP Thyroid medications. The medications are used to treat hypothyroidism. According to the FDA, the recalled lots of Nature-Throid and WP Thyroid are sub potent, meaning they do not contain the adequate dose of medication.
Bayshore Pharmaceuticals Metformin
Bayshore Pharmaceuticals, LLC is voluntarily recalling all Metformin Hydrochloride Extended-Release Tablets USP. They are recalling both 500 mg and 750 mg tablets due to the presence of N-Nitrosodimethylamine (NDMA). NDMA is a probable human carcinogen, meaning it may cause cancer.
Sundial Herbal Products
Sundial Herbal Products is recalling all products distributed between Janary 2014 and present day. The FDA is requesting recall and removal of all products because they are misbranded and misleading. The FDA says that the drugs are not approved for the claims made on the labels, such as curing or treating disease.
Acella Pharmaceuticals, LLC NP Thyroid
Acella Pharmaceuticals, LLC is recalling certain lots of hypothyroid medication NP Thyroid. The recall follows a test that showed the drug is “superpotent.” Affected lots may contain 115% more liothyronine (T3) than what the label says. Taking superpotent NP Thyroid can cause patients to experience symptoms of overactive thyroid. This is especially dangerous for patients who are pregnant.
Affected lots include:
NP Thyroid 30 mg
- Lot M329A19-1, expiration 20-Dec
- Lot M329H18-1, expiration 20-Jul
- Lot M329J18-1, expiration 20-Aug
- Lot M329J18-2, expiration 20-Aug
- Lot M329J18-3, expiration 20-Aug
- Lot M329M18-2, expiration 20-Nov
NP Thyroid 60 mg
- Lot M330J18-2,A expiration 20-Aug
- Lot M330J18-3, expiration 20-Aug
NP Thyroid 90 mg
- Lot M331G18-1, expiration 20-Jun
- Lot M331J18-1, expiration 20-Aug
- Lot M331J18-2, expiration 20-Aug
- Lot M331M18-1, expiration 20-Nov
- Lot M331M18-2, expiration 20-Nov
Amneal Pharmaceuticals, LLC Nizatidine Oral Solution
Amneal Pharmaceuticals, LLC is recalling three lots of Nizatidine Oral Solution. The medication is being recalled to do possible contamination with N-Nitrosodimethylamine (NDMA). NDMA is a probably human carcinogen, meaning it may increase the risk of developing certain cancers.
The recalled lots include:
- 06598004A. Expiration date: 04/2020
- 06599001A. Expiration date: 12/2020
- 06599002A. Expiration date: 12/2020
Eisai, Co. Belviq
Popular weight loss drug Belviq is being recalled and withdrawn from the market after a study in rats showed an increased risk of cancer while taking the medication. 7.7% of people taking Belviq developed cancer in a study, compared to 7.1% of people taking a placebo. These findings resulted in the FDA requesting recall and withdrawal.
Aurobindo Pharma USA, Inc. Mirtazapine
Aurobindo Pharma USA, Inc. is recalling a single lot of Mirtazapine, a popular antidepressant medication. The recall is due to a labeling error that could result in patients taking a higher dose than expected.
The affected lot is labeled as 7.5 mg, but the pills inside are 15mg. Taking more than recommended can cause adverse side effects.
Takeda Natpara Hypoparathyroid Drug Recall
Takeda Pharmaceutcial Company Limited is recalling all doses of Natpara, a drug used to treat hypoparathyroidism. The recall is due to the potential for rubber particles to enter the drug when puncturing the vial septum.
Mylan Pharmaceuticals Recalls Batch of Xanax (alprazolam)
Mylan Pharmaceuticals is recalling one batch of Xanax (alprazolam) due to the possibility that the tablets contain a foreign substance. Patients taking the contaminated Xanax could experience infection as a result.
Torrent Pharmaceuticals Limited Expands Losartan Recalls
Torrent Pharmaceuticals Limited is expanding the recall of certain Losartan blood pressure medications. The new recalls include:
Losartan Potassium Tablets USP
- 13668-409-10 – 50mg, 1000 count, 4DU2E009, expires 12/31/2020
- 13668-115-90 – 100mg, 90 count, 4DU3E009, expires 12/31/2020
- 13668-115-10 – 100mg, 1000 count, 4DU3E018, expires 02/28/2021
Losartan Potassium/hydrochlorothiazide tablets USP
- 13668-116-90 – 50mg/12.5mg, 90 count, BEF7D051, expires 11/30/2020
- 13668-118-90 – 100mg/25mg, 90 count, 4P04D007, expires 07/31/2020
Pfizer, Inc. RELPAX (eletriptan hydrobromide) Tablets
Pfizer is recalling two lots of RELPAX 40mg tablets due to possible contamination with bacteria. According to the U.S. Food and Drug Administration (FDA), the drugs may be contaminated with Burkholderia or Pseudomonas.
Exposure to these bacterias can cause gastrointestinal distress and possible bacterial dissemination into the bloodstream.
Bayer Kogenate Mislabeling
Bayer is recalling two lots of Kogenate FS antihemophlic factor 2000 IU vials due to their being mislabeled. Instead of containing the labeled biologic drug, the vials contain Hivi antihemophilic factor PEGylated-aucl 3000 IU.
Altaire Pharmaceuticals, Inc. OTC Natural Tears
Altaire Pharmaceuticals, Inc. is recalling over-the-counter (OTC) “natural tears.” The products, designed to treat dry eye, are being recalled due to possibly being non-sterile.
The recall includes brand and store brand names, including:
- Wal-Mart
- Walgreens
- CVS
- OCuSOFT
- Perrigo
- Accutome
- Prestige/Clear Eyes
Alvogen Fentanyl Transdermal System
Alvogen, Inc. issued a voluntary recall of two lots of Fentanyl Transdermal System 12 mc/h patches due to their being mislabeled. The recalled products were labeled 12 mcg/h, but contained patches that were 50 mcg/h.
Consumers with a recalled product can contact Alvogen Customer Complaints at 566-770-3024.
Losartan Potassium USP
- Losartan
- Torrent Pharmaceuticals Limited
- Macleods
- Camber Pharmaceuticals, Inc.
- Legacy Pharmaceutical Packaging, LLC
More Information:
- https://www.fda.gov/news-events/press-announcements/fda-provides-update-its-ongoing-investigation-arb-drug-products-reports-finding-new-nitrosamine
- https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/updated-torrent-pharmaceuticals-limited-expands-voluntary-nationwide-recall-losartan-potassium
- https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/teva-pharmaceuticals-usa-inc-issues-voluntary-nationwide-recall-losartan-potassium-25-mg-and-100-mg
- https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/vivimed-life-sciences-pvt-ltd-issues-voluntary-nationwide-recall-losartan-potassium-25-mg-50-mg-and
Mylan Institutional, LLC Levoleucovorin Injection
Hospira, Inc. 8.4% Sodium Bicarbonate Injection USP
Hospira, Inc. has voluntarily recalled certain lots of 8.4% Sodium Bicarbonate Injection USP due to particulate matter found in the vials. The particles were identified as glass. Intravenous administration of glass particles can cause serious side effects including clotting or blocking blood vessels, which can cause organ damage.
Apotex Corp. Ethinyl Estradiol Tablets, USP
Apotex Corp. is voluntarily recalling certain lots of Ethinyl Estradiol Tablets due to possibly defective blister packs. The blister packs may be arranged improperly, which could impact dosing. Patients may unknowingly take a placebo instead of the active medication, which could result in unintended pregnancy.
Valsartan and Amlodipine Tablets
Various recalls have been issued for Valsartan and Amlodipine tablets after trace amounts of impurities were detected. The impurity was identified as N-nitrosodiethylamine (NDEA), which is a probable human carcinogen. The ongoing recalls include brand names:
- Aurobindo
- Acetris
- Mylan
- Teva Pharmaceuticals
- Torrent Pharmaceuticals Limited
- Camber Pharmaceuticals, Inc.
- Actavis
- Prinston Pharmaceutical Inc. dba Solco Healthcare LLC
- Major Pharmaceuticals
Valsartan and Amlodipine is used to treat high blood pressure. Patients taking these medications are urged to contact their healthcare providers for more information.
More Information:
ICU Medical ChemoLock and ChemoClave Vial Spikes
ICU Medical has voluntarily recalled certain lots of ChemoLock and ChemoClave Vial Spikes after burr particulate was discovered in the vial. The particulate originated from the protective cap that is used during assembly. The burr particulate can enter the bloodstream during intravenous administration, and can result in embolism, organ damage, or stroke.
Dr. Reddy’s Laboratories Ltd.
Dr. Reddy’s Laboratories Ltd. Has recalled a lot of Levetiracetram 0.54% Sodium Chloride Injection single-dose infusion bags. The pre-printed text on the bag was found to be incorrect for the recalled lot. The bags were labeled as 0.75%, but the external foil was labeled as 0.54%.
Incorrect dosage of Sodium Chloride products can result in aggression, respiratory depression, depressed level of consciousness, or coma.
More Information:
Terrific Care, LLC/Medex Supply Dist., Inc. CoaguChek Test Strips
Fresenius Kabi Sodium Chloride Injection, USP, 0.9%
More Information:
Irbesartan Tablets USP 75mg, 150mg, and 300mg
ScieGen Pharmaceuticals, Inc. and Aurobindo Pharma Limited both recalled certain batches of Irbesartan tablets due to impurities found in the drug. The impurity was identified as N-nitrosodimethylamine (NDMA), which is a probable human carcinogen. Both manufacturers issued recalls and urged patients to contact their healthcare providers immediately.
Endo Pharmaceuticals Robaxin 750mg
Pharm D Solutions, LLC Sterile Compounded Drugs
Pharm D Solutions, LLC issued a voluntary recall of all sterile compounded drugs after an FDA inspection indicated pharmacy practices that increase the risk of potential contamination of sterile products. Administering compound drugs that are not sterile can cause serious side effects, and may be life-threatening.
More Information:
Camber Pharmaceuticals, Inc. Montelukast Tablets
Camber Pharmaceuticals, Inc. has voluntarily recalled a single lot of Montelukast Sodium Tablets 10mg. The recall was issued after a complaint was filed stating that a patient had received a sealed bottle labeled as Montelukast 10mg 30ct tablets, but what was in the bottle was Losartan Potassium 50mg tablets 90ct. Inadvertent use of Losartan can cause renal dysfunction, hypotension, and fatigue. Losartan contains a fetal toxicity warning as well, and therefore should not be used by pregnant women.
More Information:
Westminster Pharmaceuticals, LLC Levothyroxine and Liothyronine Tablets
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AuroMedics Pharma LLC Piperacillin and Tazobactam Injection 3.375g Vials
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Fagron Sterile Services Neostigmine Methylsulfate
Fagron Sterile Services has recalled two lots of Neostigmine Methylsulfate 5mL syringes. The recalls follows a customer complaint that some syringes were mislabeled. Syringes containing Neostigmine Methylsulfate 1mg/mL, 5mg/5mL were labeled as containing Neostigmine Methylsulfate 1mg/mL, 3mg/3mL. Neostigmine Methylsulfate overdose can cause side effects including nausea and vomiting, bradycardia, tachycardia, bronchospasm, paralysis, or Cholinergic Crisis.
More Information:
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