Records and reported status
Nov 1, 2024 FDA drug enforcement
cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
Class II Reported ongoing
Distribution: Nationwide in the USA
Official source for Diltiazem Hydrochloride Extended-Release Capsules, USP 60 mg, Twice-a-Day Dosage, Rx Only, 100 Ca... Nov 1, 2024 FDA drug enforcement
cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
Class II Reported ongoing
Distribution: Nationwide in the USA
Official source for Diltiazem Hydrochloride Extended-Release Capsules, USP 90mg, Twice-a-Day Dosage, Rx Only, 100 Cap... Nov 1, 2024 FDA drug enforcement
cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
Class II Reported ongoing
Distribution: Nationwide in the USA
Official source for Diltiazem Hydrochloride Extended-Release Capsules, USP 120mg, Twice-a-Day Dosage, Rx Only, 100 Ca... Sep 30, 2024 FDA drug enforcement
Defective Container: Firm received complaints of broken tube at the seal.
Class III Reported ongoing
Distribution: Nationwide in the US.
Official source for Ciclopirox Gel 0.77%, For Dermatologic Use Only, Not for Use in Eyes, Rx Only, a) 30 gm Tube, NDC... Sep 24, 2024 FDA drug enforcement
Defective Delivery System: The dip tube is clogged causing the spray not to work.
Class II Reported ongoing
Distribution: Nationwide in the USA
Official source for Ryaltris (olopatadine hydrochloride and mometasone fluorate) Nasal Spray, 665 mcg/25 mcg per spra... Aug 30, 2024 FDA drug enforcement
Subpotent Drug
Class II Reported completed
Distribution: Product was distributed nationwide within the United States.
Official source for Mupirocin Ointment, USP, 2%, 22 g, Rx only, Manufactured by: Glenmark Pharmaceuticals, Ltd., Colv... Jul 31, 2024 FDA drug enforcement
Failed Dissolution Specifications: below specification results
Class II Reported ongoing
Distribution: Nationwide USA
Official source for Indomethacin Extended-Release Capsules, USP, 75 mg, packaged in a) 60-count bottle (NDC 68462-325... Jul 22, 2024 FDA drug enforcement
CGMP Deviations
Class II Reported ongoing
Distribution: U.S. Nationwide
Official source for Glenmark, Azelaic Acid Gel, 15 %, 50 grams, Rx only, Manufactured by: Glenmark Pharmaceuticals Li... Jun 28, 2024 FDA drug enforcement
Failed Dissolution Specifications: results below specifications
Class II Reported ongoing
Distribution: USA Nationwide
Official source for Pravastatin Sodium Tablets, USP 80mg, packaged in a) 90-count bottle, NDC 68462-198-90; b) 500-co... May 30, 2024 FDA drug enforcement
Failed Dissolution Specifications
Class I Reported ongoing
Distribution: Nationwide
Official source for Potassium Chloride Extended-Release Capsules, USP, (750 mg) 10 mEq K, 100-count bottle, Rx Only, ... May 30, 2024 FDA drug enforcement
Failed Dissolution Specifications
Class I Reported ongoing
Distribution: Nationwide
Official source for Potassium Chloride Extended-Release Capsules, USP, (750 mg) 10 mEq K, 500-count bottle, Rx Only, ... May 30, 2024 FDA drug enforcement
CGMP Deviations
Class II Reported ongoing
Distribution: Nationwide
Official source for Potassium Chloride Extended-Release Capsules, USP, (750 mg) 10 mEq K, 100-count bottle, Rx Only, ... May 30, 2024 FDA drug enforcement
CGMP Deviations
Class II Reported ongoing
Distribution: Nationwide
Official source for Potassium Chloride Extended-Release Capsules, USP, (750 mg) 10 mEq K, 500-count bottle, Rx Only, ... May 13, 2024 FDA drug enforcement
CGMP Deviations: N-Nitroso Desmethyl Rizatriptan Impurity results that are above the FDA acceptable limit.
Class II Reported ongoing
Distribution: US Nationwide.
Official source for Rizatriptan Benzoate Orally Disintegrating Tablets, USP 5mg, 18 (3 x 6) Unit-Dose Tablets, Manufa... May 13, 2024 FDA drug enforcement
CGMP Deviations: N-Nitroso Desmethyl Rizatriptan Impurity results that are above the FDA acceptable limit.
Class II Reported ongoing
Distribution: US Nationwide.
Official source for Rizatriptan Benzoate Orally Disintegrating Tablets, USP 10mg, 18 (3 x 6) Unit-Dose Tablets, Manuf... May 10, 2024 FDA drug enforcement
CGMP Deviations: N-Nitroso Desmethyl Rizatriptan Impurity results that are above the FDA acceptable limit.
Class II Reported ongoing
Distribution: US Nationwide.
Official source for Rizatriptan Benzoate Tablets USP, 5mg, 18 (3 X 6) Unit-Dose Tablets, Manufactured for: Glenmark P... May 10, 2024 FDA drug enforcement
CGMP Deviations: N-Nitroso Desmethyl Rizatriptan Impurity results that are above the FDA acceptable limit.
Class II Reported ongoing
Distribution: US Nationwide.
Official source for Rizatriptan Benzoate Tablets USP, 10 mg, 18 (3 X 6) Unit-Dose Tablets, Manufactured for: Glenmark... Apr 17, 2024 FDA drug enforcement
Failed Dissolution Specifications
Class II Reported ongoing
Distribution: Nationwide in the USA.
Official source for Diltiazem Hydrochloride Extended-Release Capsules, USP 120 mg, Twice-a-Day Dosage, 100 Capsules p... Mar 26, 2024 FDA drug enforcement
Failed Dissolution Specifications: Out of Specification (OOS) was reported in test of dissolution at the 12th month time point in long term stability study.
Class II Reported ongoing
Distribution: Nationwide in the US
Official source for Diltiazem Hydrochloride Extended-Release Capsules, USP 120 mg, Twice-a-Day Dosage, 100 Capsules p... Jan 4, 2024 FDA drug enforcement
Failed Excipient Specifications: OOS for assay of Isopropyl Alcohol
Class II Reported terminated
Distribution: USA Nationwide
Official source for Fluocinolone Acetonide Oil, 0.01% (Ear Drops), package in 1 Oz. (20 mL fill volume) bottle, Rx on...
Reasons in these listed records cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit. Defective Container: Firm received complaints of broken tube at the seal. Defective Delivery System: The dip tube is clogged causing the spray not to work. Subpotent Drug These examples come from this result page and are not a ranking of every recall reason.
Checking Glenmark Pharmaceuticals Inc., USA Is there a recall on glenmark pharmaceuticals inc., usa right now? This archive contains 116 records, including 105 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product.
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Where can I find older records? Use monthly archives or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page.