February 26, 2025DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Atomoxetine Capsules, USP, 100 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141,
Hazard: CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
February 26, 2025DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Atomoxetine Capsules, USP, 80 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, M
Hazard: CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
February 26, 2025DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Atomoxetine Capsules, USP, 60 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, M
Hazard: CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
February 26, 2025DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Atomoxetine Capsules, USP, 40 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, M
Hazard: CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
February 26, 2025DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Atomoxetine Capsules, USP, 25 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, M
Hazard: CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
February 26, 2025DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Atomoxetine Capsules, USP, 18 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, M
Hazard: CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
February 26, 2025DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Atomoxetine Capsules, USP, 10 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, M
Hazard: CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
February 26, 2025DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Atomoxetine Capsules, USP, 100 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA
Hazard: CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
February 26, 2025DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Atomoxetine Capsules, USP, 80 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA,
Hazard: CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
February 26, 2025DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Atomoxetine Capsules, USP, 60 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA,
Hazard: CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
February 26, 2025DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Atomoxetine Capsules, USP, 40 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA,
Hazard: CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
February 26, 2025DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Atomoxetine Capsules, USP, 25 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA,
Hazard: CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
February 26, 2025DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Atomoxetine Capsules, USP, 18 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA,
Hazard: CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
February 26, 2025DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Atomoxetine Capsules, USP, 10 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA,
Hazard: CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
February 26, 2025DrugsFDA
Provepharm Inc. recalls Phenylephrine HCl Injection, USP 100 mg/10 mL (10 mg/mL) vials, Rx only, Pharmacy Bulk Package (supplied as a single uni
Hazard: Presence of Particulate Matter.
February 26, 2025DrugsFDA
AvKARE recalls Silodosin Capsules, 8mg, 90-count bottle, Rx only, Manufactured for: AvKare, Pulaski, TN 38478, Manufactured by: Amneal
Hazard: Subpotent Drug: Out of Specification (OOS) result for De hydro Impurity (0.654%) for 18 M Stability sample and low assay 94.9% (specification of NLT 95.0% NMT 105%)
February 26, 2025DrugsFDA
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories recalls Lorazepam Tablets, USP, 2mg, Unit Dose, 100 tablets per carton (10 x 10 blister packs), Rx only, The drug product contai
Hazard: Failed impurities/degradation specifications and Sub-potent Drug: Out-of-specification results were obtained during routine stability testing for Assay and Impurities.
February 26, 2025DrugsFDA
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories recalls Lorazepam Tablets, USP, 1mg, Unit Dose, 100 tablets per carton (10 x 10 blister packs), Rx only, The drug product contai
Hazard: Failed impurities/degradation specifications and Sub-potent Drug: Out-of-specification results were obtained during routine stability testing for Assay and Impurities.
February 26, 2025DrugsFDA
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories recalls Lorazepam Tablets, USP, 0.5mg, Unit Dose, 100 tablets per carton (10 x 10 blister packs), Rx only, The drug product cont
Hazard: Failed impurities/degradation specifications and Sub-potent Drug: Out-of-specification results were obtained during routine stability testing for Assay and Impurities.
February 26, 2025DrugsFDA
Fagron Compounding Services recalls fentaNYL Citrate In Sodium Chloride 1600mcg/100mL (16 mcg per mL) CII, Single use 100mL IV Bag, Fagron Sterile Services
Hazard: Lack of Assurance of Sterility
February 19, 2025DrugsFDA
AvKARE recalls Irbesartan Tablets USP, 300 mg, 50 Tablets (5 x 10) Unit Dose per carton, Manufactured for: AvKARE, Pulaski, TN 38478. N
Hazard: Out of Specification for Dissolution
February 12, 2025DrugsFDA
ENDO USA, Inc. recalls Adrenalin Chloride Solution (Epinephrine Nasal Solution, USP), 30mg/30mL (1mg/mL), packaged in 30 mL vials, Distributed
Hazard: Labeling: Not Elsewhere Classified: misleading label similar in appearance to the FDA-approved drug product Adrenalin¿ (epinephrine injection, USP)
February 12, 2025DrugsFDA
PAI Holdings, LLC. dba Pharmaceutical Associates Inc recalls Guaifenesin and Codeine Phosphate Oral Solution USP, 100mg/10 mg per 5 mL, 16 fl oz (473 ml) bottles, PAI Pharmaceutical
Hazard: Superpotent; sodium benzoate preservative
February 12, 2025DrugsFDA
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories recalls Potassium Chloride Extended-Release Tablets, USP, 10 mEq (750 mg), 100 Tablets per carton (10 x 10 unit dose blisters),
Hazard: Failed Dissolution Specifications.
February 12, 2025DrugsFDA
SKY PACKAGING recalls HydrALAZINE Hydrochloride, 100 Tablets (10x10), USP, 50mg, Rx only, Manufactured by Strides Pharma Science Ltd, Bengalur
Hazard: Failed Impurities/Degradation Specifications
February 12, 2025DrugsFDA
SKY PACKAGING recalls HydrALAZINE Hydrochloride, 25 mg, 100 Unit Dose Tablets (10x10), USP, Rx only, Manufactured by Strides Pharma Science Lt
Hazard: Failed Impurities/Degradation Specifications
February 12, 2025DrugsFDA
Teva Pharmaceuticals USA, Inc recalls Granix (tbo-filgrastim) Injection 300 mcg/0.5 mL, Single Dose prefilled syringe, packaged as a) 1 syringe in 1 CARTON, N
Hazard: Failed Stability Specifications - 12-month stability test result for one of the known peptides is below the specification limit
February 12, 2025DrugsFDA
RemedyRepack Inc. recalls Carvedilol 25 mg Tablet, QTY: 30 Tablets per Blister Pack (3 x 10 blister cards), Rx Only, MFG by: Glenmark, Mahwah, NJ
Hazard: CGMP deviations: presence of N-Nitroso Carvedilol Impurity-1 (NNC 1), above the FDA recommended acceptable intake limit.
February 12, 2025DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Carvedilol Tablets, USP, 12.5 mg, Rx only, a)500 Tablets, NDC 68462-164-05; b) 100 Tablets, NDC 68462-164-01, Manufactur
Hazard: CGMP Deviations:N-Nitroso Carvedilol I impurity (NNCI-I) were found to be failing per current FDA recommended limit.
February 12, 2025DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Carvedilol Tablets, USP, 25 mg, Rx only, a)500 Tablets, NDC 68462-165-05; b) 100 Tablets, NDC 68462-165-01, Manufactured
Hazard: CGMP Deviations:N-Nitroso Carvedilol I impurity (NNCI-I) were found to be failing per current FDA recommended limit.