CDSCO Drug Alert: 48 Drug Samples Flagged

New Delhi: In its latest drug alert, the apex drug regulatory body, the Central Drugs Standard Control Organization (CDSCO), has flagged 48 medicine batches for failing to qualify for a random drug sample test for the month of August.

These drug samples which are declared not of standard quality include Misoprostol Tablets I.P. 200 mcg manufactured by Synokem Pharmaceuticals, Cefotaxime for Injection IP 500 mg manufactured by Maan Pharmaceuticals, Telmisartan, and Chlorthalidone Tablets manufactured by Pure & Cure Healthcare, Paracetamol 120 mg plus Chlorpheniramine Maleate 2 mg/ 5 ml syrup (COLD OUT) manufactured by Fourrts (India) Laboratories and others.

Apart from this, the list further includes popular diabetes drug combination Metformin Hydrochloride Prolonged Release and Glimepiride Tablets IP (GLIMESTAR M2 FORTE) manufactured by Mankind Pharma and AMTAS PRP (Amlodipine and Perindopril Tablets) manufactured by Intas Pharmaceuticals.

This came after analysis and tests conducted by the CDSCO Drugs Control Department on 1166 samples. Out of these, 1118 samples were found to be of standard quality while 48 of them were declared as Not of Standard Quality (NSQ).

A few of the reasons why the drug samples tested failed were the failure of the assay, failure of the dissolution test, failure of the disintegration test, failure of the sterility test, etc.

The samples collected were tested in five laboratories, namely CDL Kolkata, CDTL Chennai, CDTL Mumbai, RDTL Chandigarh, and RDTL Guwahati.

List of Drugs, Medical Devices, and Cosmetics declared as Not of Standard Quality/Spurious/Adulterated/Misbranded for the Month of AUGUST – 2023

List of Drugs, Medical Devices and Cosmetics declared as Not of Standard Quality/Spurious/Adulterated/Misbranded for the Month of AUGUST – 2023
Total number of samples tested					1166
Total number of samples declared as of Standard Quality					1118
Total number of samples declared as Not of Standard Quality					48
Total number of samples declared as Spurious					00
Total number of samples declared as Misbranded					00
S.No	Name of Drugs/medical device/cosmetics	Batch No.	Date of Manufa cture	Date of Expiry	Manufactured By	Reason for failure	Drawn By	From
1	MOL-PCB Syrup (Paracetamol, Bromhexine Hydrobromide Chlorpheniramine Maleate, Phenylephrine Hydrochloride, Menthol Syrup) – 60 ml	L22541	03/2023	02/202 5	Aan Pharma Private Limited, 816/1, Pramukh Ind. Estate, Rakanpur 382 721, Ta. Kalol Dist. Gandhinagar (Guj.) India	pH, Assay of Bromhexine Hydrobromide and Phenylephrine Hydrochloride	CDSCO, Ahmedaba d	CDL Kolkata
2	Nifedipine Sustain Release Tablets I.P. 20 mg	T230307	03/2023	02/202 5	Medisky Pharmaceuticals Pvt. Ltd., Plot No. 260, GIDC, Talod – 383 215, Sabarkantha, Gujarat	Dissolution	CDSCO, Ahmedaba d	CDL Kolkata
3	DICLOGLOBE 50 (Diclofenac Sodium Tablets I.P. 50 mg)	GT23026	01/2023	12/202 5	Globela Pharma Pvt. Ltd., 357, 358, G.I.D.C. Sachin, Surat- 394 230, Gujarat, India	Disintegration	CDSCO, Ahmedaba d	CDL Kolkata

4	Trimax Expectorant (Terbutaline Sulphate with BromhexineHCl& Guaiphenesin),	23009	01/2023	10/202 4	Norris Medicines Limited, Plot No. 901/3-5, G.I.D.C. Estate, Ankleshwar – 393 002 (Gujarat).	Assay of Bromhexine Hydrochloride &Menthol.This sample is found to contain 0.118% w/v of Ethylene Glycol and this sample does not give positive test for Diethylene Glycol	CDSCO, Ahmedaba d	CDL Kolkata
5	Frusemide Injection IP (2ml)	AI22236	08/2022	07/202 4	Alves Healthcare Private Limited, NangalUperla, Swarghat Road, Nalagarh, Dist. Solan, Himachal Pradesh - 174101	pH	CDSCO, Ahmedaba d	CDL Kolkata
6	Refined Glycerin CP Grade	21100637	10/2021	09/202 5	Adani Wilmar, Pitampura, New Delhi – 110 034	Assay of Glycerin.Thi sample is found to contain 0.025% w/w of Ethylene Glycol and does not give positive result for Diethylene Glycol	CDSCO, Ahmedaba d	CDL Kolkata
7	Sterile Noradrenaline Concentrate IP (2mg /1ml)	INABB23 01	04/2023	03/202 5	Samarth Life Sciences Pvt. Ltd., Unit II: Plot No.2, Industrial Area, Lodhimajra, Baddi, H.P. 173205, India	Description & Particulate Matter	CDSCO, Ahmedaba d	CDL Kolkata
8	CyproheptadineHCl with Tricholine Citrate Syrup (Sylpro Plus Syrup)	33002	05/2023	04/202 5	Norris Medicines Limited, Plot No. 801/P, 901/4-5, G.I.D.C. Estate, Ankleshwar – 393 002 (Gujarat).	Assay of TricholineCitrate.This sample is found to contain Diethylene Glycol 0.243%w/v and Ethylene Glycol 0.171%w/v	CDSCO, Ahmedaba d	CDL Kolkata

9	Sibolone (Tibolone Tablets IP)	PLSB230 1	02/2023	09/202 5	Phaarmasia Ltd., Unit – II, Plot No. 145, Phase V, IDA, Jeedimetla (V), Qutubullapur (M), MedchalMalkajgiri (Dist.) 500 055	Dissolution	CDSCO, Hyderabad	CDL Kolkata
10	Methylprednisolone Sodium Succinate for Injection USP 40mg	22MS03	11/2022	10/202 4	SAI Parenterals Limited, D1 & D4, Survey No.280, Phase- V, IDA, Jeedimetla, Hyderabad- 500055, Telangana, India.	Uniformity of Dosage Units, Loss on Drying & Assay of Methylprednisolone Sodium Succinate	CDSCO, Hyderabad	CDL Kolkata
11	Misoprostol Tablets I.P. 200 mcg	22S1GTA 026	01/2022	12/202 3	Synokem Pharmaceuticals Ltd., Plot No.35-36, Sector- 6A, I.I.E (SIDCUL), Ranipur (BHEL), Haridwar- 249403, Uttarakhand.	Assay	CDSCO Bangalore	CDL Kolkata
12	Cefotaxime for Injection IP 500 mg	CD22002	03/2022	02/202 4	Maan Pharmaceuticals Ltd., Plot-1, G.I.D.C., Phase II, Modhera Road, Mehsana – 384 002, Gujarat, India	Particulate Matter & Clarity of Solution	CDSCO Bangalore	CDL Kolkata
13	Bacillus Clausii Spores Suspension (EbaniproSuspension)	AFL2258 8	08/2022	07/202 4	Aarmed Formulation Pvt. Ltd., Survey No. 431/2, Plot No.1, Steel Town, Moraiya, Tal. Sanand, Distt. Ahmedabad (Gujarat)	Purity & Specified Pathogen (Pseudomonas aeruginosa)	Drug Control Departmen t Jammu & Kashmir	CDL Kolkata
14	(Absorbable Surgical Suture U.S.P (synthetic) 70 cm), (Monofilament Poliglecaprone 25) (STERGIC)	TV22212 7	09/2022	08/202 5	Sugii Surgical India Pvt. Ltd., No.3, Old No. 49/51, 8th Main, Peenya 2nd Stage, Bengaluru – 560058	Diameter	CDSCO Bangalore	CDL Kolkata

15	Erythromycin Stearate Tablets IP 250 mg	AT23118	04/2023	03/202 5	Alves Healthcare Private Limited, Village: NangalUperla, Swarghat Road, Tehsil, Nalagarh, Distt. Solan - 174101 (H.P.), India	Dissolution	CDSCO, South Zone Chennai	CDL Kolkata
16	Selamer-400 Tablets (Sevelamer Carbonate Tablets 400 mg)	MT22612 4B	12/2022	11/202 4	Mascot Health Series Pvt. Ltd, Plot No.79, 80, Sec-6A, IIE, Sidcul, Haridwar – 249 403, Uttarakhand, India.	Description	CDSCO, South Zone Chennai	CDL Kolkata
17	Telmisartan and Chlorthalidone Tablets	PF8C006	09/2022	08/202 4	Pure & Cure Healthcare Pvt. Ltd., Plot No. 26A, 27-30, Sector-8A, I.I.E., SIDCUL, Ranipur Haridwar – 249 403, Uttarakhand	Dissolution of Chlorthalidone	CDSCO East Zone Kolkata	CDL Kolkata
18	AMTAS PRP (Amlodipine and Perindopril Tablets)	K2200008 2	01/2022	12/202 4	Intas Pharmaceuticals Ltd., Bhageykhola, Rangpo, East Sikkim -737132, India.	Assay of Perindopril Erbumine	CDSCO East Zone Kolkata	CDL Kolkata
19	Esylate (Etamsylate Injection 250 mg)	I-2359	12/2021	11/202 3	Jackson Laboratories Pvt. Ltd., Majitha Road, Amritsar 143001 (India).	Description, Particulate Matter & Extractable Volume	CDSCO East Zone Kolkata	CDL Kolkata
20	Montelukast Sodium and Levocetirizine Hydrochloride Tablets IP (Montzer-C)	MTZ2200 3	12/2022	11/202 4	Tirupati Medicare Limited, Nahan Road, Paonta Sahib, Distt. Sirmour (H.P.) 173 205.	Dissolution of Montelukast	CDSCO East Zone Kolkata	CDL Kolkata

21	Nicomode-2 (Nicoumalone Tablets IP 2 mg)	T222932	02/2023	01/202 5	United Bioceuticals Pvt. Ltd., Plot No. 33C, Industrial Park IV, Begumpur, Haridwar - 249402, Uttarakhand	Related Substances	CDSCO East Zone Kolkata	CDL Kolkata
22	Erythromycin Stearate Tablets (Enthrocin-500)	ATG3A04 8	01/2023	12/202 4	Anrose Pharma, 147, Mauza Sansiwala, P.O. Barotiwala, Tehsil Kasauli, Distt. Solan (H.P.).	Dissolution	CDSCO East Zone Kolkata	CDL Kolkata
23	Cefoperazone & Sulbactam for injection	S3A099	01/2023	12/202 4	Arion Healthcare, GMP Certified Company Vill. Kishanpura, Baddi, Distt. Solan 174 101 (H.P).	Assay of Sulbactam	CDSCO Hyderabad	CDL Kolkata
24	Doxycycline and Lactic Acid Bacillus Capsules(DOXORIA-L)	SOC- 2062A	11/2022	10/202 4	Symbiosis Pharmaceuticals Pvt. Ltd., At C/o Ovation Remedies, Behind IITT Engg. College, Trilokpur Road, Kala Amb- 173030 (Sirmour), HP	Assay /Content of Gram positive rod shaped spore forming bacteria	CDSCO East Zone Kolkata	CDL Kolkata
25	Amoxycillin Capsules IP 500 MG (AMOXYCILLIN 500)	C-5076	Oct- 2022	Sep- 2024	Jackson Laboratories Pvt.Ltd., 22-24, Majitha Road, Bye Pass, Amritsar-143 001	TEST FOR DISSOLUTION	CDSCO Subzone Bangalore	CDTL Chennai
26	Ciprofloxacin Hydrochloride Tablets IP 500 mg	0700323	Feb- 2023	Jan- 2025	Karnataka Antibiotics & Pharmaceuticals Limited, Plot No.14, II Phase, Peenya, Bangalore-560058.	TEST FOR DISSOLUTION	CDSCO South Zone Chennai	CDTL Chennai

27	Ofloxacin & Metronidazole Benzoate Suspension (VIVFLOX-MZ Suspension) (For Paediatric USE ONLY)	PFS-1204	Nov- 2022	Oct- 2024	Proceed Formulations, 17, Ind. Area, Morthikri, Ramgarh-Derabassi Road,, Derabassi – 140 201.	ASSAY OF METRONIDAZOLE BENZOATE AND OFLOXACIN	CDSCO South Zone Chennai	CDTL Chennai
28	Metronidazole & Ofloxacin Suspension (nor-metrogyl o Suspension)	XSWN22 006	April- 2022	Mar- 2024	Hema Laboratories Pvt. Ltd. Plot No.29, Pharma City, Selaqui Industrial Area, Dehradun – 248 011 (State Uttarakhand)	ASSAY OF METRONIDAZOLE BENZOATE AND OFLOXACIN	CDSCO South Zone Chennai	CDTL Chennai
29	Ibuprofen and Paracetamol Dispersible Tablets (Ibucon Plus Kid)	C211143 003	March- 2023	Feb- 2026	Concept Pharmaceuticals Ltd., A-28/3, MIDC, Chikalthana, Aurangabad – 431 006	Diameter & Uniformity of Dispersion	CDSCO West Zone Mumbai	CDTL Mumbai
30	Calamine, Zinc Oxide, Aloe vera & Light Liquid Paraffin (Calmin Lotion)	C-012	Apr- 2022	March- 2025	Gladios Products Pvt Ltd., 31, Virat Industiral Estate, Dhanot, Gandhinagar, Gujarat – 382721	Specific gravity	CDSCO Zonal Office Ahmedaba d	CDTL Mumbai
31	Lorazepam Tablets I.P. 2 mg	LZMT100 6	Feb- 2023	Jan- 2025	Unicure India Ltd., C-21, 22 & 23, Sector-3, Noida- 201301, Distt. : Gautam Budh Nagar (U.P.)	Dissolution and Assay	CDSCO West Zone Mumbai	CDTL Mumbai
32	Calcium and Vitamin D3 Tablets I.P.	KTB2176 AL	Nov - 2022	Apr- 2024	Karnataka Antibiotics & Pharmaceuticals Limited., Plot No.37, Site No.34/4, NTTF Main Road, 2nd Phase, Peenya Industrial Area, Bengluru- 560058. At: Plot No. 5-9, Survey No.38/2,	Uniformity of content for Vitamin D3	CDSCO West Zone Mumbai	CDTL Mumbai

					Aliyali Palghar (W), Dist. Palghar- 401404 (M.S).
33	Levocetirizine and Amrboxol Syrup (C & C Syrup)	BL23015	Feb- 2023	Jan- 2025	Baxil Pharma Pvt. Ltd., 10km, Nainital Highway, Shyampur, Haridwar 249408, Uttarakhand.	Assay of Ambroxol Hydrochloride	CDSCO Ghaziabad	RDTL Chandigarh
34	Povidone-Iodine Ointment USP 5% w/w	P1040	Aug- 2022	Jul- 2025	Babu Ram Om Prakash (BROP), Trilokpur Road, Ogli Village, Kala Amb,	Assay of Povidon Iodine calculated asAvailable Iodine	CDSCO Ghaziabad	RDTL Chandigarh
35	Cefpodoxime Proxetil for Oral Suspension IP	UCST- 2310	Mar- 2023	Feb- 2025	Ultra Drugs Pvt. Ltd., Manpura, Nalagarh, Distt.Solan-174101 (H.P.)	pH	CDSCO Sub-Zone Jammu	RDTL Chandigarh
36	Diclofenac Prolonged- Release Tablets IP 100 mg	CHT- 3037	Jan- 2023	Dec- 2024	Cotec Healthcare Pvt. Ltd., NH.No. 74, Roorkee- Dehradun Highway, Kishanpur, Roorkee-247667 (Uttarakhand)	Dissolution	CDSCO Ghaziabad	RDTL Chandigarh
37	Aspirin Gastro-resistant and Atorvastatin Capsules IP (75mg/10mg)	54CAT09 6	Sep- 2022	Aug- 2024	Swiss Garnier Life sciences, 21-23, Industrial Area, Mehatpur, Dist. Una, Himachal Pradesh- 174315.INDIA	Dissolution (buffer stage) of Aspirin and The Assay of Atrovastatin Calcium calculated as Atorvastatin	CDSCO Ghaziabad	RDTL Chandigarh
38	Mupirocin Ointment IP (MUPIJAI OINTMENT)	008	Sep- 2022	Aug- 2024	Baxil Pharma Pvt. Ltd., 10km, Nainital Highway, Shyampur, Haridwar 249408,	Assay of Mupirocin	Drug Control Departmen t Ghaziabad	RDTL Chandigarh

39	The auto disable syringe (KOJAK SELINGE)	312053KJ M1	Mar- 2023	Feb- 2028	HINDUSTAN SYRINGES & MEDICAL DEVICES LTD., 174, 178/25, BALLABGARH, FARIDABAD, INDIA-121004	Design (Piston/Plunger Assembly) Fit of piston in barrel	CDSCO Sub Zone Baddi	RDTL Chandigarh
40	Rabeprazole Gastro- resistant Tablets IP (RABALKEM-20)	RBL2202 0RH	Oct- 2022	Sep- 2024	Ravian Life Science Pvt. Ltd., Plot No.34, Sector-8A, IIE, SIDCUL, Haridwar-249 403, Uttarakhand INDIA.	Dissolution	Drug Control Departmen t Assam	RDTL, Guwahati
41	Paracetamol 120 mg + Chlorpheniramine Maleate 2 mg/ 5ml syrup (COLD OUT)	SF001A0 1	Jan- 2022	Dec- 2024	Fourrts (India) Laboratories Pvt. Ltd., Vandalur Road, Kelambakkam-603 103. Tamil Nadu, INDIA.	Content of Ethylene Glycol 1.9%w/v & Diethylene Glycol 0.14%w/v	CDSCO, South zone, Chennai	RDTL Guwahati
42	Paracetamol 120 mg + Chlorpheniramine Maleate 2 mg/ 5 ml syrup (COLD OUT)	SF001B0 1	Feb- 2022	Jan- 2025	Fourrts (India) Laboratories Pvt. Ltd., Vandalur Road, Kelambakkam-603 103. Tamil Nadu, INDIA.	Content of Ethylene Glycol 1.22%w/v	CDSCO, South zone, Chennai	RDTL Guwahati
43	Paracetamol 120 mg + Chlorpheniramine Maleate 2 mg/ 5 ml syrup (COLD OUT)	SF001A0 2	Jan- 2022	Dec- 2024	Fourrts (India) Laboratories Pvt. Ltd., Vandalur Road, Kelambakkam-603 103. Tamil Nadu, INDIA.	Content of Ethylene Glycol 2.23%w/v& Diethylene Glycol 0.17%w/v	Drugs Inspector, CDSCO, South zone, Chennai	RDTL Guwahati
44	CALCIUM ACETATE TABLETS USP 667 mg., (Lanum)	D222313	Jul-2022	Jun- 2025	STANDFORD LABORATORIES PRIVATE LIMITED, 8, Industrial Area, Mehatpur, Dist. Una, H.P. - 174315	Assay	Drugs Inspector, Guwahati, Assam	RDTL Guwahati

45	GENTAMYCIN INJECTION I.P. (GENTAVIK 2ml.)	TGL0223 0318	Feb- 2023	Jan- 2025	T & G MEDICARE, Village- Kunjahal, P.O. Baddi, Distt. Solan (H.P.)	Sterillity and Bacterial Endotoxins Test	lnspector of Drugs, Arunachal Pradesh	RDTL Guwahati
46	Pantoprazole Gastro Resistant Tablets I.P. (PAVE -40)	BBT2217 94	May - 2022	Apr- 2024	Biomax Biotechnics (P) Ltd., 261, HSIIDC, Industrial Estate, Alipur, Barwala- 134118 (Haryana)	Dissolution	Drugs Inspector, RAnchii,Jh arkhand	RDTL Guwahati
47	Metformin Hydrochloride Prolonged Release and Glimepiride Tablets IP (GLIMESTAR® M2 FORTE)	P9IAV007	Nov- 2022	Oct 2024	MANKIND PHARMA LTD. Doring Block, Bermiok Elaka, Dist. Namchi, Sikkim 737126	Disintegration and Dissoluton	Drugs Inspector, Mizoram	RDTL Guwahati
48	COMPOUND SODIUM LACTATE INJECTION I.P.	03BF173 7	Aug- 2022	Jul- 2025	PASCHIM BANGA PHARMACEUTICAL, NH-31 TIN MILE HAT, SONAPUR HAT, P.S.-CHOPRA, DIST: UTTAR DINAJPUR, PIN- 733214 (W.B.)	Bacterial Endoxtoxins Test	Drugs Inspector, AJZAWL, Mizoram	RDTL Guwahati

Also Read:Drug Alert: 51 Drug samples fail to qualify CDSCO test

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