August 3, 2022DrugsFDA
Mylan Pharmaceuticals Inc recalls Insulin Glargine (Insulin glargine-yfgn) Injection, 100 units/mL (U-100), 3 mL prefilled pens (NDC 49502-394-71), packag
Hazard: Labeling: Missing label: Label missing from some prefilled pens.
August 3, 2022DrugsFDA
SUN PHARMACEUTICAL INDUSTRIES INC recalls Divalproex Sodium Delayed-Release Tablets, USP 500mg, Rx Only, 100 Tablets, Distributed by: Sun Pharmaceutical Industrie
Hazard: Failed Dissolution Specifications: Failure occurred during routine stability testing of dissolution test.
August 3, 2022DrugsFDA
The Procter & Gamble Company recalls Crest 3D White Fluoride Anticavity Toothpaste, Advanced Triple Whitening, 0.243% sodium fluoride, Net Wt. 5.6 oz (158 g)
Hazard: Labeling: Missing label: the product tube was missing a label and contained a different formulation.
August 3, 2022DrugsFDA
Teva Pharmaceuticals USA Inc recalls Testosterone Gel 1% (25mg testosterone/2.5g of gel) 2.5 g per unit dose, Rx Only, 30 unit-dose packets per box. Manufact
Hazard: Superpotent Drug: Out of specification assay result was obtained during stability testing.
August 3, 2022DrugsFDA
Dr. Reddy's Laboratories, Inc. recalls Lansoprazole Delayed-Release Orally Disintegrating Tablets, 35 mg, 100-count blisters per carton, 10 Packs of 10 Tablets
Hazard: FAILED DISSOLUTION SPECIFICATIONS
August 3, 2022DrugsFDA
Dr. Reddy's Laboratories, Inc. recalls Lansoprazole Delayed-Release Orally Disintegrating Tablets, 15 mg, 100-count blisters per carton, 10 Packs of 10 Tablets
Hazard: FAILED DISSOLUTION SPECIFICATIONS
August 3, 2022DrugsFDA
Valor Compounding Pharmacy, Inc DBA Valor Compounding Pharmacy recalls Nifedipine WSP 0.2% Ointment, 60 gram tubes, Rx only, Valor Compounding Pharmacy, 2461 Shattuck Ave., Berkeley, CA 9470
Hazard: Subpotent and Superpotent Drug
July 27, 2022DrugsFDA
Loud Muscle Science recalls Launch Sequence Aphrodisia Capsules, 4-count tins, ASIN B07QB3S2LV, UPC Code 661020846957.
Hazard: Marketed Without An Approved NDA/ANDA: Unapproved Drug based on label claims.
July 27, 2022DrugsFDA
Loud Muscle Science recalls Launch Sequence Euphoria Capsules, 10- count tins, ASIN B08ZJX4V9J, UPC Code 661020846864.
Hazard: Marketed Without An Approved NDA/ANDA: Unapproved Drug based on label claims.
July 27, 2022DrugsFDA
Loud Muscle Science recalls Launch Sequence Capsules, Dietary Supplement, 60- count bottles, ASIN B07TLPWXDS, UPC Code 641378938375.
Hazard: Marketed Without An Approved NDA/ANDA: Unapproved Drug based on label claims.
July 27, 2022DrugsFDA
Loud Muscle Science recalls Launch Sequence Aphrodisia Capsules, 4-count tins, ASIN B07QB3S2LV, UPC Code 661020846957.
Hazard: Marketed Without An Approved NDA/ANDA: Product found to contain undeclared tadalafil, an ingredient found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug.
July 27, 2022DrugsFDA
Loud Muscle Science recalls Launch Sequence Euphoria Capsules, 10- count tins, ASIN B08ZJX4V9J, UPC Code 661020846864.
Hazard: Marketed Without An Approved NDA/ANDA: Product found to contain undeclared tadalafil, an ingredient found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug.
July 27, 2022DrugsFDA
Loud Muscle Science recalls Launch Sequence Capsules, Dietary Supplement, 60- count bottles, ASIN B07TLPWXDS, UPC Code 641378938375.
Hazard: Marketed Without An Approved NDA/ANDA: Product found to contain undeclared tadalafil, an ingredient found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug.
July 27, 2022DrugsFDA
Amazon.com, Inc. recalls Artri King Reforzado con Ortiga y Omega 3 tablets, 500 mg, 100-count bottle, Hecho en Mexico por: PLANTAS MEDICINALES D
Hazard: Marketed Without An Approved NDA/ANDA: FDA laboratory analysis found the product to contain undeclared diclofenac.
July 27, 2022DrugsFDA
Amazon.com, Inc. recalls Ortiga mas Ajo Rey Reforzado con Omega 3, 6 y 9, is packaged in a carton containing 30 tablets (500 mg c/u) in a bottle
Hazard: Marketed Without An Approved NDA/ANDA: FDA laboratory analysis found the product to contain undeclared diclofenac.
July 27, 2022DrugsFDA
Amazon.com, Inc. recalls Artri Ajo King Reforzado con Ortiga y Omega 3 tablets, 500 mg, 100-count bottle, Hecho en Mexico por: PLANTAS MEDICINAL
Hazard: Marketed Without An Approved NDA/ANDA: FDA laboratory analysis found the product to contain undeclared diclofenac.
July 27, 2022DrugsFDA
Apotex Corp. recalls Aripiprazole Tablets, USP 20 mg, packaged in a) 1,000-count bottle (NDC 60505-2676-8, UPC 3 60505 26768 2), b) 30-count
Hazard: Failed dissolution specifications: OOS for dissolution at the 12-month stability time point.
July 27, 2022DrugsFDA
CIPLA recalls Difluprednate Ophthalmic Emulsion, 0.05%, 5ml bottles, Rx only, Mfd. by: Cipla Ltd., India At M/S Indoco Remedies Limite
Hazard: Lack of Assurance of Sterility: customer complaint for defective container where breakage of the protective cap exposes tip of eye drop which could compromise sterility.
July 27, 2022DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Aspirin and Extended-Release Dipyridamole Capsules, 25mg/200 mg, 60-count bottle, Rx Only, Manufactured for: Glenmark Ph
Hazard: Failed Tablet/Capsule Specification : Capsule breakage
July 27, 2022DrugsFDA
Nephron Sterile Compounding Center LLC recalls Succinylcholine Chloride Injection, USP, 200 mg/10 mL (20 mg/mL) syringe, packaged in 5 x 10 mL Pre-Filled Syringes per
Hazard: Lack of Assurance of Sterility
July 27, 2022DrugsFDA
Nephron Sterile Compounding Center LLC recalls Anticoagulant Sodium Citrate Solution, USP 4%, 200 mg/5 mL (40 mg/mL) syringe, packaged in 5 x 5 mL Pre-Filled Syringes
Hazard: Lack of Assurance of Sterility
July 27, 2022DrugsFDA
Nephron Sterile Compounding Center LLC recalls 8.4% Sodium Bicarbonate Injection, USP, 4.2 g/50 mL (84 mg/mL) 1 mEq/mL syringe, packaged in 1 x 50 mL Pre-Filled Syring
Hazard: Lack of Assurance of Sterility
July 27, 2022DrugsFDA
Nephron Sterile Compounding Center LLC recalls Ropivacaine HCl 123 mg (2.46 mg/mL), Clonidine HCl 0.04 mg (0.0008 mg/mL), Ketorolac Tromethamine 15 mg (0.3 mg/mL) Inje
Hazard: Lack of Assurance of Sterility
July 27, 2022DrugsFDA
Nephron Sterile Compounding Center LLC recalls Rocuronium Bromide Injection, 50 mg/5 mL (10 mg/mL) syringe, packaged in 5 x 5 mL Pre-Filled Syringes per carton, 6 x 5
Hazard: Lack of Assurance of Sterility
July 27, 2022DrugsFDA
Nephron Sterile Compounding Center LLC recalls Phenylephrine HCl Injection, USP, 1 mg/10 mL (100 mcg/mL) syringe, packaged in 5 x 10 mL Pre-Filled Syringes per carton,
Hazard: Lack of Assurance of Sterility
July 27, 2022DrugsFDA
Nephron Sterile Compounding Center LLC recalls Phenylephrine HCl Injection, USP, 0.8 mg/10 mL (80 mcg/mL)syringe, packaged in 5 x 10 mL Pre-Filled Syringes per carton,
Hazard: Lack of Assurance of Sterility
July 27, 2022DrugsFDA
Nephron Sterile Compounding Center LLC recalls Phenylephrine HCl Injection, USP, 0.4 mg/10 mL (40 mcg/mL) syringe, packaged in 5 x 10 mL Pre-Filled Syringes per carton
Hazard: Lack of Assurance of Sterility
July 27, 2022DrugsFDA
Nephron Sterile Compounding Center LLC recalls Oxytocin 30 Units/500 mL (0.06 Units/mL) in 0.9% Sodium Chloride Injection, USP IV bag, packaged in 10 x 1 IV Bag per ca
Hazard: Lack of Assurance of Sterility
July 27, 2022DrugsFDA
Nephron Sterile Compounding Center LLC recalls Neostigmine Methylsulfate Injection, USP, 5 mg/5 mL (1 mg/mL) syringe, packaged in 5 x 5 mL Pre-Filled Syringes per cart
Hazard: Lack of Assurance of Sterility
July 27, 2022DrugsFDA
Nephron Sterile Compounding Center LLC recalls Neostigmine Methylsulfate Injection, USP, 4 mg/4 mL (1 mg/mL) syringe, packaged in 5 x 4 mL Pre-Filled Syringes per cart
Hazard: Lack of Assurance of Sterility