Glenmark Pharmaceuticals Inc., USA recalls
53 recalls on record · FDA
Every recall we have on record for Glenmark Pharmaceuticals Inc., USA, compiled from federal safety data. Check the hazard, the remedy, and how serious each one is, and always confirm on the official notice.
Ondansetron Orally Disintegrating Tablets, USP, 4mg, 30 Tablets (3 blistercards each…
Defective container: Preferred Pharmaceuticals received a letter from the manufacturer Glenmark, that the blister packs are not fully sealed and tablets falling out. Preferred Pharmaceuticals purchased the finished product and repackaged the product for sale.
Bisoprolol Fumarate and Hydrochlorothiazide Tablets, USP, 2.5 mg/6.25 mg, packaged as (a)…
Cross Contamination with Other Products: Testing of reserve samples showed presence of traces of ezetimibe
Azelaic Acid Gel, 15%, 50 grams, For Topical Use Only, Rx only, Manufactured by: Glenmark…
CGMP Deviations: Market complaints received for gritty texture (grainy)
Carvedilol Tablets, USP, 12.5 mg, 500-count bottle, Rx only, Manufactured by: Glenmark…
CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity above the current Acceptable Intake Level.
Carvedilol Tablets, USP, 25 mg, 500 Tablets per carton, Rx Only, Manufactured by:…
CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm
Carvedilol Tablets, USP, 12.5 mg, 500 Tablets per carton, Rx Only, Manufactured by:…
CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm
Carvedilol Tablets USP 25 mg, 500 -Count bottle, Rx Only, Manufactured by: Glenmark…
CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit
Carvedilol Tablets USP 12.5 mg, 500-Count bottle, Rx Only, Manufactured by: Glenmark…
CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit
Theophylline (Anhydrous) Extended-Release Tablets, 600 mg, 100 Tablets per bottle, Rx…
OOS results reported for the Dissolution (by UV) test.
Carvedilol Tablets USP 3.125mg Tablets a.)100-count bottle (NDC 68462-162-01), b.)…
CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit
Carvedilol Tablets USP 6.25 mg, a.)100-count bottle (NDC 68462-163-01), b.) 500-count…
CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit
Cetirizine Hydrochloride Tablets, USP, 10mg, 365-count packs, Rx Only, Manufactured for:…
CGMP Deviations
Ranolazine Extended-Release Tablets 1000mg, 60-count bottle, Rx Only, Manufactured by:…
CGMP Deviations
Pravastatin Sodium Tablets, USP, 80mg, a).90-count bottle (16714-570-01), b). 500-count…
CGMP Deviations
Fenofibrate Capsules 67 mg, USP, 100-count bottle, Rx Only, Manufactured by: Glenmark…
CGMP Deviations
Frovatriptan Succinate Tablets 2.5mg, 9-count bottle, Rx Only, Manufactured by: Glenmark…
CGMP Deviations
Naproxen Sodium Tablets, USP, 550mg, 100-count bottles, Rx Only, Manufactured by:…
CGMP Deviations
Pravastatin Sodium Tablets, 20mg, a).500-count bottle (NDC# 68462-196-05), b). 90-count…
CGMP Deviations
Metformin Hydrochloride Extended-Release Tablets 1000mg, 90-count bottle. Manufactured…
CGMP Deviations
Solifenacin Succinate Tablets 5mg, a.) 30-count bottle (NDC# 68462-386-30) b.) 90-count…
CGMP Deviations
Gabapentin Tablets 600mg, 500-count bottles, Rx Only, Manufactured by: Glenmark…
CGMP Deviations
Prochlorperazine Maleate Tablets, 10mg, 100-count bottles, Rx Only, Manufactured by:…
CGMP Deviations
Saxagliptin Tablets, USP, 2.5mg, a). 30-count bottle (NDC# 68462-726-30), b).90-count…
CGMP Deviations
Lacosamide Tablets 150mg, 60-count bottle, Rx Only, Manufactured by: Glenmark…
CGMP Deviations
Propafenone Hydrochloride Extended-Release Capsules 325mg, 60-count bottle, Rx Only…
CGMP Deviations
Voriconazole Tablets 50mg, 30-count bottle, Rx Only, Manufactured by: Glenmark…
CGMP Deviations
Colesvelam Hydrocholoride Tablets 625mg, 180-count bottle, Rx Only, Manufactured by:…
CGMP Deviations
Saxagliptin Tablets 5mg, a). 30-count bottle (NDC# 68462-727-30) b.) 90-count bottle (…
CGMP Deviations
Nitroglycerin Sublingual Tablets 0.4MG 100-count carton, Rx Only, Manufactured by:…
CGMP Deviations
Acetaminophen and Ibuprofen (NSAID) Tablets, 250 mg/125 mg a). 144-count packets (NDC#…
CGMP Deviations
Lacosamide Tablets, 100mg , 60-count bottle, Rx Only, Manufactured by: Glenmark…
CGMP Deviations
Pravastatin Sodium Tablets, USP, 20mg, a).90-count bottle, Rx Only, Mfd for: Northstar Rx…
CGMP Deviations
Carvedilol Tablets, USP 12.5 mg, 500-count bottle, Rx Only, Manufactured by: Glenmark…
CGMP Deviations
Atomoxetine Capsules, USP, 80 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark…
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Atomoxetine Capsules, USP, 60 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark…
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Atomoxetine Capsules, USP, 18 mg, 30 capsule bottles, Rx Only, Manufactured for:…
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Atomoxetine Capsules, USP, 100 mg, 30 capsule bottles, Rx Only, Manufactured for:…
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Atomoxetine Capsules, USP, 10 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark…
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Carvedilol Tablets, USP, 12.5 mg, Rx only, a)500 Tablets, NDC 68462-164-05; b) 100…
CGMP Deviations:N-Nitroso Carvedilol I impurity (NNCI-I) were found to be failing per current FDA recommended limit.
Carvedilol Tablets, USP, 25 mg, Rx only, a)500 Tablets, NDC 68462-165-05; b) 100 Tablets,…
CGMP Deviations:N-Nitroso Carvedilol I impurity (NNCI-I) were found to be failing per current FDA recommended limit.
chlorproMAZINE Hydrochloride Tablets, USP, 10mg, 100-count bottle, RX only, Manufactured…
CGMP Deviations: N-Nitroso-Desmethyl Chlorpromazine impurity (NNDCI) were found to be failing per current FDA recommended limit.
Diltiazem Hydrochloride Extended-Release Capsules, USP 90mg, Twice-a-Day Dosage, Rx Only,…
cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
Diltiazem Hydrochloride Extended-Release Capsules, USP 120 mg, Rx Only, 100 Capsules,…
cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
Diltiazem Hydrochloride Extended-Release Capsules, USP 120mg, Twice-a-Day Dosage, Rx…
cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
Indomethacin Extended-Release Capsules, USP, 75 mg, packaged in a) 60-count bottle (NDC…
Failed Dissolution Specifications: below specification results
Potassium Chloride Extended-Release Capsules, USP, (750 mg) 10 mEq K, 100-count bottle,…
CGMP Deviations
Rizatriptan Benzoate Orally Disintegrating Tablets, USP 10mg, 18 (3 x 6) Unit-Dose…
CGMP Deviations: N-Nitroso Desmethyl Rizatriptan Impurity results that are above the FDA acceptable limit.
Rizatriptan Benzoate Tablets USP, 5mg, 18 (3 X 6) Unit-Dose Tablets, Manufactured for:…
CGMP Deviations: N-Nitroso Desmethyl Rizatriptan Impurity results that are above the FDA acceptable limit.
Rizatriptan Benzoate Orally Disintegrating Tablets, USP 5mg, 18 (3 x 6) Unit-Dose…
CGMP Deviations: N-Nitroso Desmethyl Rizatriptan Impurity results that are above the FDA acceptable limit.
Naproxen Tablets, USP 250mg, 100-count bottle, Rx Only, Manufactured by: Glenmark…
Labeling: Label Mix-Up-Indomethacin bottles may be labeled as Naproxen
Deferasirox Tablets for Oral Suspension, 500mg, 30-count bottle, Rx only, Manufactured…
Failed Dissolution Specifications
Bisoprolol Fumarate and Hydrochlorothiazide Tablets, USP, 5mg/6.25mg, 100-count Bottle,…
Failed Impurities/Degradation Specifications
Zonisamide Capsules, USP, 50 mg, packaged in 100-count bottles, Rx only, Manufactured by:…
cGMP deviations