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Alembic Pharmaceuticals Limited

Pharmaunternehmen8 erfasste Produkte
8
erfasste Produkte
283.448
Meldungen insgesamt
19
dokumentierte Rückrufe
66,7%
schwerwiegend insgesamt
Produkte
8 von 8 angezeigt
ProduktZugelassenMeldungen ↓Top-SignalRückrufe
201078.131Hämorrhagische Anämie5
—69.814Arzneimittelreaktion mit Eosinophilie und systemischen Symptomen (DRESS)0
—59.849Infektion der unteren Atemwege0
200941.144Nieren-Hämangiom0
198713.393Makuladegeneration13
20119.105Abnorme Träume0
—8.068Erhöhter Augeninnendruck0
19963.944Schmerzen an der Infusionsstelle1
Rückrufhistorie · 19 dokumentiert
DatumKlasseGrundFirma
17. Feb. 2026IIDefective container; inadequately sealed blister packaging.The Harvard Drug Group LLC
16. Dez. 2025IIIFailed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the specification limit.Alembic Pharmaceuticals Limited
10. Okt. 2025IIIFailed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the specification limit.Alembic Pharmaceuticals Limited
25. Juli 2025IICGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.Alembic Pharmaceuticals Limited
9. Mai 2025IIPresence of Foreign Tablets/Capsules; customer complaint found one Tadalafil 5mg tablet inside a sealed 500-count bottle of Celecoxib 200mg capsuleAlembic Pharmaceuticals Limited
12. Dez. 2024IICGMP Deviations: Presence of N-nitroso-Dabigatran impurity above recommended interim limitAscend Laboratories, LLC
12. Dez. 2024IICGMP Deviations: Presence of N-nitroso-Dabigatran impurity above recommended interim limitAscend Laboratories, LLC
30. Aug. 2024IISubpotent DrugGlenmark Pharmaceuticals Inc., USA
14. März 2023IICGMP Deviations: Detection of N-nitroso-dabigatran (NDAB) impurity levels above the Acceptable Daily Intake Limit.Ascend Laboratories, LLC
14. März 2023IICGMP Deviations: Detection of N-nitroso-dabigatran (NDAB) impurity levels above the Acceptable Daily Intake Limit.Ascend Laboratories, LLC
13. Apr. 2022IIcGMP deviations: Temperature abuseMckesson Medical-Surgical Inc. Corporate Office
10. Juni 2020IILabeling: Label mix up: Bottles labeled as aripiprazole 2 mg, 30 count had aripiprazole 5 mg tablets, 100 count.Alembic Pharmaceuticals Limited
18. Juli 2016IIPenicillin Cross ContaminationGlaxoSmithKline, LLC
18. Juli 2016IIPenicillin Cross ContaminationGlaxoSmithKline, LLC
18. Juli 2016IIPenicillin Cross ContaminationGlaxoSmithKline, LLC
13. Aug. 2015IIPenicillin Cross Contamination and Presence of Foreign Substance. Product was contaminated with penicillin and foreign substances during manufacturing process.GlaxoSmithKline, LLC.
13. Aug. 2015IIPenicillin Cross Contamination and Presence of Foreign Substance. Product was contaminated with penicillin and foreign substances during manufacturing process.GlaxoSmithKline, LLC.
14. Nov. 2014IIPenicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.Attix Pharmaceuticals
5. Nov. 2012IIDefective container; damaged bottles could allow moisture to get into the bottle and thus may impair the quality of the productBoehringer Ingelheim Roxane Inc

Klasse I = begründete Wahrscheinlichkeit schwerwiegender Schäden · Klasse II = vorübergehend oder reversibel · Klasse III = Schaden unwahrscheinlich.

Registrierungsstatus

Einige Produkte von Alembic Pharmaceuticals Limited sind nicht für die Anwendung am Menschen FDA-registriert. Für nicht registrierte Substanzen (Peptide, SARMs ohne Humanzulassung) existiert kein legitimer Anbieter für die Anwendung am Menschen. Das Fehlen eines Bezugswegs ist die Sicherheitsinformation.