Alembic Pharmaceuticals Inc.

Pharmaceutical company10 products tracked

products tracked

744,315

total reports

recalls on record

78.3%

serious overall

Products

showing 10 of 10

Product	Approved	Reports ↓	Top signal	Recalls
methotrexate —	1953	484,893	Synovitis	14
paclitaxel —	1992	95,870	Myelosuppression	7
candesartan —	1998	61,711	Wheezing	12
candesartan cilexetil —	1998	28,000	Hyperkalaemia	12
sumatriptan succinate —	1992	25,906	Migraine	7
rivastigmine —	2000	18,798	On and off phenomenon	3
itraconazole —	1992	11,466	Aspergillus infection	7
bosutinib —	2012	8,855	Chronic myeloid leukaemia	0
asenapine —	2009	8,632	Anosognosia	3
pivmecillinam —	2024	184	Documented hypersensitivity to administered product	0

Recall history · 45 on record

Date	Class	Reason	Firm
Aug 1, 2024	III	Presence of Foreign Tablets: Potential presence of Fludrocortisone Acetate Tablet USP 0.1 mg within the Methotrexate 2.5 mg 100-count Bottle.	Amneal Pharmaceuticals, LLC
Sep 22, 2023	III	Failed Tablet/Capsule Specifications: Tablets were observed to have an unsmooth surface with two tablets demonstrating illegible tablet identification and scoring.	West-Ward Columbus Inc
Dec 22, 2022	II	Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.	Pharmacy Innovations
Jan 26, 2022	II	CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.	CARDINAL HEALTHCARE
Dec 6, 2021	II	Lack of Assurance of Sterility	Edge Pharma, LLC
Sep 13, 2021	III	Failed Impurities/Degradation Specifications; out of specification for Related Compound	Viatris
Apr 19, 2021	III	Incorrect Product Formulation; product was manufactured with the incorrect Art Cherry Flavor flavoring agent instead of Art Black Cherry Flavor flavoring agent	SigmaPharm Laboratories LLC
Apr 19, 2021	III	Incorrect Product Formulation; product was manufactured with the incorrect Art Cherry Flavor flavoring agent instead of Art Black Cherry Flavor flavoring agent	SigmaPharm Laboratories LLC
Apr 1, 2021	II	Failed Dissolution Specifications	Jubilant Cadista Pharmaceuticals, Inc.
Mar 22, 2021	III	Failed Impurities/Degradation Specifications	Macleods Pharma Usa Inc
Mar 15, 2021	II	CGMP Deviations: Intermittent exposure to temperature excursion during storage.	Cardinal Health Inc.
Oct 2, 2020	III	Out-of-specification organic impurity results obtained during routine stability testing.	Mylan Pharmaceuticals Inc.
Mar 19, 2020	II	Lack of Assurance of Sterility; the media used to conduct post-compounding sterility testing for the Methotrexate product was expired.	Edge Pharma, LLC
Jun 12, 2019	II	Lack of Assurance of Sterility	Infusion Options, Inc.
Jun 12, 2019	II	Lack of Assurance of Sterility	Infusion Options, Inc.
Jun 12, 2019	II	Lack of Assurance of Sterility	Infusion Options, Inc.
Jun 12, 2019	II	Lack of Assurance of Sterility	Infusion Options, Inc.
Feb 9, 2018	II	CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.	American Pharmaceutical Ingredients LLC
May 18, 2017	II	Labeling; Label Mixup; blister lidding foil and shell-pack labeled as 10 mg but package actually contains 5 mg tablets	Forest Laboratories, LLC
Mar 6, 2017	III	Cross-contamination with other products -Related Substances test for Rivastigmine Tartrate Capsules USP, 1.5 mg showed a peak for Ranitidine.	Dr. Reddy's Laboratories, Inc.
May 17, 2016	II	Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.	Well Care Compounding Pharmacy
May 17, 2016	II	Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.	Well Care Compounding Pharmacy
Jan 26, 2016	III	Failed Impurities/Degradation Specifications; 9 month stability (manufacturer)	Amerisource Health Services
Dec 31, 2015	III	Failed Impurities/Degradation Specifications; 9 month stability timepoint	Sandoz Inc
Aug 3, 2015	II	Failed Dissolution Specifications	Dr. Reddy's Laboratories, Inc.
Mar 18, 2015	I	Presence of Particulate Matter	Mylan Institutional LLC
Nov 14, 2014	II	Penicillin 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
Nov 14, 2014	II	Penicillin 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
Nov 14, 2014	II	Penicillin 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
Nov 14, 2014	II	Penicillin 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
Oct 16, 2014	III	Failed Impurities/Degradation Specifications: Out of specification (OOS) results were observed for CAD-II, CAD-V and Total Impurities.	Apotex Inc.
Oct 16, 2014	III	Failed Impurities/Degradation Specifications: Out of specification (OOS) results were observed for CAD-II, CAD-V and Total Impurities.	Apotex Inc.
Oct 16, 2014	III	Failed Impurities/Degradation Specifications: Out of specification (OOS) results were observed for CAD-II, CAD-V and Total Impurities.	Apotex Inc.
Oct 16, 2014	III	Failed Impurities/Degradation Specifications: Out of specification (OOS) results were observed for CAD-II, CAD-V and Total Impurities.	Apotex Inc.
Oct 2, 2014	III	Failed Impurities/Degradation Specifications: An Out of Specification (OOS) result was generated for the 18 month stability time point for ketone cilexetil impurity and total impurities.	Sandoz, Inc
Aug 21, 2014	III	Failed Impurity/Degradation Specification; high out of specification for CAD II degradant	Apotex Corp.
Nov 1, 2013	II	Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.	Natures Pharmacy & Compounding Center
Jul 2, 2013	II	Labeling: Label Mixup: CANDESARTAN CILEXETIL, Tablet, 16 mg may have potentially been mislabeled as the following drug: IRBESARTAN, Tablet, 150 mg, NDC 65862063830, Pedigree: W003649, EXP: 6/25/2014.	Aidapak Services, LLC
Jul 2, 2013	II	Labeling: Label Mixup; ITRACONAZOLE, Capsule, 100 mg may be potentially mislabeled as FAMCICLOVIR, Tablet, 500 mg, NDC 00093811956, Pedigree: AD54549_4, EXP: 5/20/2014.	Aidapak Services, LLC
May 20, 2013	I	Presence of Particulate Matter: Found during examination of retention samples.	Sandoz Incorporated
May 2, 2013	II	Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.	THE COMPOUNDING SHOP, INC.
Mar 20, 2013	II	Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes	Clinical Specialties Compounding Pharmacy
Jun 27, 2012	II	The affected lots of Carboplatin Injection, Cytarabine Injection, Methotrexate Injection, USP, and Paclitaxel Injection are being recalled due to visible particles embedded in the glass located at the neck of the vial. There may be the potential for product to come into contact with the embedded particles and the particles may become dislodged into the solution.	Hospira Inc.
Jun 27, 2012	II	The affected lots of Carboplatin Injection, Cytarabine Injection, Methotrexate Injection, USP, and Paclitaxel Injection are being recalled due to visible particles embedded in the glass located at the neck of the vial. There may be the potential for product to come into contact with the embedded particles and the particles may become dislodged into the solution.	Hospira Inc.
May 21, 2012	II	Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.	Franck's Lab Inc., d.b.a. Franck's Compounding Lab

Class I = reasonable probability of serious harm · Class II = temporary or reversible · Class III = unlikely to cause harm.

Registration status

Some products from Alembic Pharmaceuticals Inc. are not FDA-registered for human use. For unregistered substances (peptides, SARMs without human registration), no legitimate human-use supplier exists. The absence of a sourcing route is the safety information.