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Drug recalls

Drug recalls from FDA, newest first.
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6 recalls

Sandoz Focalin XR Extended-Release Capsules

Labeling: Incorrect or Missing Lot and/or Exp Date.

Low risk, FDA, Labeling error

Glenmark Alyacen 7/7/7 and Norethindrone and Ethinyl Estradiol Tablets

Failed Impurities/Degradation Specifications: This recall is being initiated due to out-of-specification results total impurities.

Moderate risk, FDA, Drug impurity

IntegraDose Compounding Services Vasopressin Syringes

Vasopressin 2 Units/2 mL in 0.9% Sodium Chloride is subpotent.

Moderate risk, FDA, Wrong drug strength

VistaPharm Kerr Insta-Char Activated Charcoal

KERR INSTA-CHAR activated charcoal products did not meet the OTC Monograph.

Moderate risk, FDA, Quality testing problem

1 recall

Golden State Medical Supply Niacin Extended-Release Tablets

Niacin extended-release tablets failed dissolution specifications during stability testing.

Moderate risk, FDA, Drug dissolving problem

3 recalls

Amneal Primidone Tablets

Primidone Tablets, USP, 50 mg may be cross-contaminated with Acemetacin API.

Low risk, FDA, Contamination

Ascend Laboratories Minocycline Hydrochloride Extended-Release Tablets

Minocycline Hydrochloride Extended-Release Tablets failed dissolution specifications during testing.

Moderate risk, FDA, Drug dissolving problem

Zep Alcohol Sanitizer Spray

Zep is recalling its Alcohol Sanitizer Spray because of microbial contamination of sterile products.

Moderate risk, FDA, Sterility problem

2 recalls

BEEKEEPER'S NATURALS Saline Nasal Spray, Sinus Congestion Rinse

Saline nasal spray may contain Aspergillus spp. and could cause serious infections in at-risk people.

High risk, FDA, Contamination

Blood Bank of Hawaii Red Blood Cells, Leukocytes Reduced

Red Blood Cells, Leukocytes Reduced were collected from a donor with travel history to a malarial endemic area but not assessed for residency.

Moderate risk, FDA, Blood donor screening

4 recalls

Sun Pharmaceutical Industries Budesonide Inhalation Suspension

Budesonide Inhalation Suspension contains black or brown specs and particles in the solution.

Moderate risk, FDA, Foreign object

Breckenridge Duloxetine Delayed-Release Capsules

Duloxetine Delayed-Release Capsules contain an impurity above the FDA recommended interim limit.

Moderate risk, FDA, Drug impurity

LifeServe Blood Center Red Blood Cells, Leukocytes Reduced, Irradiated

Red blood cells were collected from a donor who had traveled to an area designated as endemic for malaria.

Moderate risk, FDA, Blood donor screening

Gulf Coast Regional Blood Center Red Blood Cells and Pooled Cryoprecipitated AHF

Red blood cells and pooled cryoprecipitated AHF may have been prepared incorrectly.

Moderate risk, FDA

1 recall

BD ChloraPrep Clear Applicators

BD ChloraPrep Clear Applicators were recalled for lack of assurance of sterility or non-sterility.

High risk, FDA, Sterility problem

1 recall

Fresenius Kabi Epinephrine Injection

Epinephrine Injection failed impurities and degradations specifications.

Low risk, FDA, Drug impurity

5 recalls

Gas-X Extra Strength Softgels

Gas-X Extra Strength Softgels may be contaminated with a diluted propylene glycol-based coolant, which could cause nausea, vomiting, abdominal pain.

High risk, FDA, Chemical contamination

LifeShare Blood Center Red Blood Cells, Leukocytes Reduced

Red Blood Cells, Leukocytes Reduced were collected from an unsuitable donor due to a donor screening deviation.

Moderate risk, FDA, Blood donor screening

LifeShare Blood Center Red Blood Cells, Leukocytes Reduced

Red Blood Cells, Leukocytes Reduced were collected from an unsuitable donor due to a screening deviation.

Moderate risk, FDA, Blood donor screening

LifeShare Blood Centers Red Blood Cells, Leukocytes Reduced

Red Blood Cells, Leukocytes Reduced were distributed without documentation of arm inspection.

Low risk, FDA, Blood donor screening

Bloodworks Platelets Extended Dating

Platelets Extended Dating were distributed without a visual inspection.

Low risk, FDA, Quality testing problem

5 recalls

Lannett Niacin Extended-Release Tablets

Niacin Extended-release Tablets failed dissolution specifications during stability testing.

Moderate risk, FDA, Drug dissolving problem

Guardian Drug Antacid Tablets

Antacid tablets contain small metallic particles.

Moderate risk, FDA, Foreign object

Forte BioPharma Xyvona (Levorphanol Tartrate Tablets)

Xyvona (levorphanol tartrate tablets) has a labeling issue and is not marketed under the proprietary name.

Moderate risk, FDA, Labeling error

Asclemed USA Duloxetine DR Capsules

Duloxetine DR Capsules contain a nitrosamine impurity above the acceptable limit.

Moderate risk, FDA, Drug impurity

American Red Cross Blood Services Blood Components

American Red Cross Blood Services Blood Components, for which arm preparation may have been performed incorrectly, were distributed.

Moderate risk, FDA

2 recalls

Spectra Medical Devices Lidocaine HCl Injection

Lidocaine HCl Injection USP may lack sterility.

Moderate risk, FDA, Sterility problem

Ascend Laboratories Amlodipine and Olmesartan Medoxomil Tablets

Amlodipine and Olmesartan Medoxomil Tablets have failed dissolution specifications, with olmesartan medoxomil content below specifications.

Moderate risk, FDA, Drug dissolving problem

1 recall

Eugia Lidocaine HCl Injection

Lidocaine HCl Injection has a label wrap that covers the barcode, making it hard to scan.

Low risk, FDA, Labeling error

1 recall

Better Weather Actives Fix Elixir

Better Weather Fix Elixir may contain undeclared Mitragynine and Mitragynine Pseudoindoxyl, which can cause nausea, vomiting, and other effects.

FDA

1 recall

AbbVie Pred Mild Ophthalmic Suspension

Pred Mild ophthalmic suspension failed stability specifications.

Low risk, FDA, Quality testing problem

3 recalls

Aveva Nicotine Transdermal System Patch

The patch failed impurity tests due to elevated oxidative-related impurities.

Low risk, FDA, Drug impurity

Rhode Island Blood Center Red Blood Cells, Leukocytes Reduced

Red Blood Cells, Leukocytes Reduced were collected from a donor who traveled in a malaria endemic area.

Moderate risk, FDA, Blood donor screening

ImpactLife PF24RT24 Plasma

PF24RT24 Plasma was distributed after incomplete donor screening.

Moderate risk, FDA, Blood donor screening

1 recall

Mogo Pure Moringa Oleifera Capsules

Moringa capsules may be contaminated with Salmonella Typhimurium.

High risk, FDA, Salmonella

1 recall

Lloyd ToxiBan Charcoal-Kaolin Suspension

ToxiBan Charcoal-Kaolin Suspension has microbial levels exceeding specification limits.

Moderate risk, FDA, Contamination

2 recalls

IntegraDose Compounding Services Fentanyl Citrate Injection

FentaNYL Citrate injection is subpotent.

Moderate risk, FDA, Wrong drug strength

Nephronex Vitamin B-Complex, Vitamin C & Folic Acid Dietary Supplement Oral Liquid

The oral liquid supplement contains black particles in the liquid.

Moderate risk, FDA, Foreign object

3 recalls

ANI Pharmaceuticals Estradiol Gel

Estradiol Gel packets may be empty or partially full.

Moderate risk, FDA, Packaging defect

UCB Cimzia Prefilled Syringes

Cimzia (certolizumab pegol) prefilled syringes lack assurance of sterility.

Moderate risk, FDA, Sterility problem

Zydus Erythromycin Tablets

Zydus Pharmaceuticals is recalling its Zydus Erythromycin Tablets, USP because of CGMP deviations and presence of N-Nitroso-Desmethyl-Erythromycin above the recommended acceptable intake limit.

Moderate risk, FDA, Drug impurity

3 recalls

Gas-X Simethicone Antigas Softgels

Gas-X antigas softgels have incomplete inactive ingredient information on the carton labeling.

Moderate risk, FDA, Labeling error

Lupin Pharmaceuticals Liraglutide Injection

Liraglutide Injection contains a white thread-like structure in the cartridge.

Moderate risk, FDA, Foreign object

American National Red Cross Cryoprecipitated AHF

American National Red Cross Cryoprecipitated AHF failed to meet minimum specifications for fibrinogen levels.

Moderate risk, FDA, Quality testing problem

5 recalls

Safecor Health Atomoxetine Capsules

Atomoxetine Capsules HCL, 10 mg Capsules are mislabeled as 25 mg capsules.

Moderate risk, FDA, Labeling error

American Health Packaging Primidone Tablets

Primidone Tablets are contaminated with trace amounts of Acemetacin API, which can cause cross contamination.

Low risk, FDA, Contamination

Sagent Pharmaceuticals Busulfan Injection

Busulfan Injection failed impurities and degradation specifications.

Low risk, FDA, Drug impurity

Golden State Medical Supply Primidone Tablets

Primidone Tablets may be contaminated with trace amounts of Acemetacin.

Low risk, FDA, Contamination

Lannett Primidone Tablets

Primidone Tablets are contaminated with trace amounts of Acemetacin.

Low risk, FDA, Contamination

1 recall

Dechra Ophthavet Ophthalmic Solution for Dogs and Cats

Ophthavet Ophthalmic Solution has a potential quality concern at the manufacturing site.

Moderate risk, FDA, Sterility problem