November 15, 2023DrugsFDA
Grato Holdings, Inc. recalls V-FORCE Homeopathic, 1 FL OZ (30 ml) per glass bottle, Distributed by: BioActive Nutritional, Inc., 1803 N. Wickham Rd.
Hazard: Incorrect Product Formulation: product contains Active Ingredient Glandula Suprarenalis Suis 8X instead of Glandula Suprarenalis Bovine 8X (as stated on the product label).
November 15, 2023DrugsFDA
Zydus Pharmaceuticals (USA) Inc recalls Oxybutynin Chloride Extended-Release Tablet USP, 15 mg, 100 count bottles, Rx Only, Manufactured by: Cadila Healthcare L
Hazard: Failed Dissolution Specifications-out-of-specification (OOS) test results observed for dissolution at the 6 month long term time point.
November 15, 2023DrugsFDA
Zydus Pharmaceuticals (USA) Inc recalls Oxybutynin Chloride Extended-Release Tablet USP, 10 mg, 100 count bottles Rx Only, Manufactured by: Cadila Healthcare L
Hazard: Failed Dissolution Specifications-out-of-specification (OOS) test results observed for dissolution at the 6 month long term time point.
November 15, 2023DrugsFDA
Zydus Pharmaceuticals (USA) Inc recalls Oxybutynin Chloride Extended-Release Tablet USP, 5 mg, 100 count bottles, Rx Only, Manufactured by: Cadila Healthcare Lt
Hazard: Failed Dissolution Specifications-out-of-specification (OOS) test results observed for dissolution at the 6 month long term time point.
November 15, 2023DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Deferasirox Tablets for Oral Suspension, 500mg, 30-count bottle, Rx only, Manufactured for: Glenmark Pharmaceuticals Inc
Hazard: Failed Dissolution Specifications
November 15, 2023DrugsFDA
Zyla Life Sciences US Inc. recalls Oxaydo (oxycodone HCl, USP) tablets, 7.5 mg, 100 Tablets per bottle, Rx only, Distributed by: Zyla Life Sciences US Inc.
Hazard: Sub-potent Drug: Lower potency than labeled.
November 15, 2023DrugsFDA
VistaPharm LLC recalls Mycophenolate Mofetil for Oral Suspension, USP, 200 mg/mL, Rx Only, bottle, Manufactured for: VistaPharm, Inc., Largo, F
Hazard: Defective Container: The adaptor does not fit into the neck of the bottle after reconstitution with water.
November 15, 2023DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Ranolazine Extended-Release Tablets 500mg, 60 Tablets per bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Lim
Hazard: Failed Dissolution Specifications: Out of specification for dissolution.
November 15, 2023DrugsFDA
MEDLINE INDUSTRIES, LP - Northfield recalls Clinical TREAT Antifungal Powder, Vanilla Scent, 3 OZ (85 g) tube, Active Ingredient: Miconazole Nitrate 2.0% w/w Antifu
Hazard: CGMP deviations: the product was shipped from the Manufacturer to a Medline warehouse and released to stock while it was still under investigation for low assay results on the active ingredient miconazole nitrate.
November 15, 2023DrugsFDA
Amneal Pharmaceuticals of New York, LLC recalls Extended Phenytoin Sodium Capsules, USP, 100 mg, 100-count bottle, Distributed by Amneal Pharmaceuticals LLC Bridgewater
Hazard: Failed Dissolution Specifications
November 15, 2023DrugsFDA
Taro Pharmaceuticals Inc. recalls Hydrocortisone 1% and Acetic Acid 2% Otic Solution USP, 10ml dropper bottle, RX Only, Mfd. by: Taro Pharmaceuticals Inc.
Hazard: Failed Impurities/Degradation Specifications:Out-of-Specification result for Hydrocortisone related impurity and slightly lower than the established level of the Hydrocortisone Assay obtained during stability testing.
November 15, 2023DrugsFDA
AbbVie Inc. recalls Synthroid, Levothyroxine Sodium Tablets, USP 125mcg (0.125mg), 100-count bottle, Rx Only AbbVie Inc. North Chicago, IL 6
Hazard: Labeling: Wrong Barcode- One (1) of every forty (40) unit dose blister will contain incorrect barcode information that causes a 125mcg unit dose is scanned as 200mcg unit dose.
November 15, 2023DrugsFDA
PAR Sterile Products LLC recalls Buprenorphine HCl, Injection, 0.3mg/mL, For Intramuscular or Intravenous Use, Rx Only, 1mL Single Dose Vial, (supplied i
Hazard: Crystallization; identified as Buprenorphine free base
November 15, 2023DrugsFDA
Dr. Reddy's Laboratories, Inc. recalls Montelukast Sodium Tablets, USP 10 mg, Rx Only, 1000 count bottle, Distributed by: Dr. Reddy's Laboratories., Princeton,
Hazard: Presence of Foreign Tablet(s)/Capsule(s): A foreign tablet was found in a bottle of Montelukast Sodium Tablets, USP 10mg, identified as metoprolol 25 mg.
November 8, 2023DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Bisoprolol Fumarate and Hydrochlorothiazide Tablets, USP, 5mg/6.25mg, 100-count Bottle, RX only, Manufactured by: Glenma
Hazard: Failed Impurities/Degradation Specifications
November 8, 2023DrugsFDA
SUN PHARMACEUTICAL INDUSTRIES INC recalls Liothyronine Sodium Tablets, USP, 25 mcg, 100-count bottles, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc
Hazard: Failed Impurities/Degradation Specifications.
November 8, 2023DrugsFDA
SUN PHARMACEUTICAL INDUSTRIES INC recalls Liothyronine Sodium Tablets, USP, 5 mcg, 100-count bottles, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc.
Hazard: Failed Impurities/Degradation Specifications.
November 8, 2023DrugsFDA
Safecor Health, LLC recalls Strong Iodine Solution U.S.P. (Lugol's Solution) (Iodine 5%), 14 mL Glass Dropper bottle in box, RX only, Safecor Health
Hazard: CGMP Deviations: Recall due to the absence of USP CGMP compendial requirements.
November 8, 2023DrugsFDA
Padagis US LLC recalls Gynazole-1, (Butoconazole Nitrate) Vaginal Cream USP, 2%, Net Wt 5.8 g per pre-filled applicator, packaged in 1 prefille
Hazard: Incorrect Product Formulation: Hydrophilic Colloidal Silica was used to manufacture the product rather than Hydrophobic Colloidal Silica as required by the manufacturing process.
November 8, 2023DrugsFDA
Edenbridge Pharmaceuticals, LLC recalls Opium Tincture, USP (Deodorized), 10 mg/mL of anhydrous morphine, packaged in 118 mL (4 Fl oz) bottles, Rx only, Manufac
Hazard: Subpotent Drug
November 8, 2023DrugsFDA
GlaxoSmithKline Consumer Healthcare Holdings LLC recalls TUMS Antacid, Calcium Carbonate USP 1000 mg, Assorted Berries flavor, chewable tablets, 72-count bottle, Dist. by: GSK C
Hazard: Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool.
November 8, 2023DrugsFDA
GlaxoSmithKline Consumer Healthcare Holdings LLC recalls TUMS Antacid, Calcium Carbonate USP 1000 mg, Assorted Berries flavor, Chewable Tablets, packaged in 265-count bottle, Di
Hazard: Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool.
November 8, 2023DrugsFDA
GlaxoSmithKline Consumer Healthcare Holdings LLC recalls TUMS Antacid, Calcium Carbonate USP 1000 mg, Assorted Berries flavor, Chewable Tablets, packaged in 12-count roll, Dist.
Hazard: Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool.
November 8, 2023DrugsFDA
GlaxoSmithKline Consumer Healthcare Holdings LLC recalls TUMS Antacid, Calcium Carbonate USP 1000 mg, Assorted Berries flavor, Chewable Tablets, packaged in 72-count bottles, Di
Hazard: Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool.
November 8, 2023DrugsFDA
GlaxoSmithKline Consumer Healthcare Holdings LLC recalls TUMS Antacid, Calcium Carbonate USP 1000 mg, Assorted Fruit flavor, Chewable Tablets, packaged in 160-count bottles, Di
Hazard: Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool.
November 8, 2023DrugsFDA
GlaxoSmithKline Consumer Healthcare Holdings LLC recalls TUMS Antacid, Calcium Carbonate USP 1000 mg, Peppermint flavor, chewable tablets, packaged in 12-count roll, Dist. by: G
Hazard: Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool.
November 8, 2023DrugsFDA
GlaxoSmithKline Consumer Healthcare Holdings LLC recalls TUMS Antacid, Calcium Carbonate USP 1000 mg, Peppermint flavor, chewable tablets, 72-count bottle, Dist. by: GSK CH, War
Hazard: Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool.
November 1, 2023DrugsFDA
Denver Solutions, LLC DBA Leiters Health recalls VANCOmycin HCI PF, 1.5 g added to 0.9% Sodium Chloride 250 mL IV Bag, Rx only, Leiters Compounding Health, 13796 Compark
Hazard: Labeling: Not Elsewhere Classified
November 1, 2023DrugsFDA
Denver Solutions, LLC DBA Leiters Health recalls VANCOmycin HCI PF, 1.25 g added to 0.9% Sodium Chloride 250 mL IV Bag, Rx only, Leiters Compounding Health, 13796 Compar
Hazard: Labeling: Not Elsewhere Classified
November 1, 2023DrugsFDA
Denver Solutions, LLC DBA Leiters Health recalls Oxytocin synthetic, 30 Units added to 0.9% Sodium Chloride 500mL IV Bag (0.06 Units per mL), Rx only, Leiter Compounding
Hazard: Labeling: Not Elsewhere Classified