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List of Drug Alert March2023

The document summarizes test results for 48 samples of drugs, medical devices, and cosmetics that were declared as not meeting standards in March 2023. Key details include: - A total of 1497 samples were tested, with 1449 passing as meeting standards and 48 failing standards. - The 48 failing samples represented drugs (tablets, injections), medical devices (bandages, cotton wool), and cosmetics (toothpaste). - Reasons for failure included dissolution problems, presence of impurities, and failure to meet specifications for threads per unit area, surface active substances, and bacterial counts. - Failing samples came from a range of manufacturers across India.

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0% found this document useful (0 votes)
149 views11 pages

List of Drug Alert March2023

The document summarizes test results for 48 samples of drugs, medical devices, and cosmetics that were declared as not meeting standards in March 2023. Key details include: - A total of 1497 samples were tested, with 1449 passing as meeting standards and 48 failing standards. - The 48 failing samples represented drugs (tablets, injections), medical devices (bandages, cotton wool), and cosmetics (toothpaste). - Reasons for failure included dissolution problems, presence of impurities, and failure to meet specifications for threads per unit area, surface active substances, and bacterial counts. - Failing samples came from a range of manufacturers across India.

Uploaded by

MOHANA VAMSI
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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Download as PDF, TXT or read online on Scribd
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List of Drugs, Medical Devices and Cosmetics declared as Not of Standard

Quality/Spurious/Adulterated/Misbranded for the Month of March – 2023.

Total number of samples tested 1497


Total number of samples declared as of Standard Quality 1449
Total number of samples declared as Not of Standard Quality 48
Total number of samples declared as Spurious -
Total number of samples declared as Misbranded -

S.No Name of Batch No./Date of Reason for failure Drawn By From


Drugs/medical Manufacture/Date of
device/cosmetic Expiry/Manufactured
s By
1. Telmirid-40 B. No.: RT220651 Dissolution CDSCO, CDTL
(Telmisartan Mfg dt: 08/2022 East Zone Kolkata
Tablets I.P. 40 Exp dt: 07/2024 Kolkata
mg) Mfd by: M/s. Ridley Life
Sciences Pvt. Ltd., D-
1651, DSIDC, Indl.
Complex, Narela, Delhi
110 040.
2. Domperidone B. No.: 3100422 Related Substances CDSCO CDTL
Tablets I.P. 10 Mfg dt: 07/2022 East Zone Kolkata
mg Exp dt: 06/2025 Kolkata
Mfd by: M/s. Karnataka
Antibiotics &
Pharmaceuticals
Limited, Plot No. 14 II
Phase, Peenya,
Bengaluru – 560 058.
3. Pioglitazone B. No.: GM21077 Dissolution CDSCO CDTL
Hydrochloride Mfg dt: 08/2021 East Zone Kolkata
Tablets IP 30 mg Exp dt: 07/2023 Kolkata
Mfd by: M/s. Skymap
Pharmaceuticals Pvt.
Ltd., B-3, Dev Bhoomi
Industrial Estate,
Puhana Iqbalpur Road,
Roorkee -247667
Uttarakhand..
4. Domperidone B. No.: T-2203140 Related Substances CDSCO CDTL
Tablets I.P. 10 Mfg dt: 03/2022 East Zone Kolkata
mg Exp dt: 02/2024 Kolkata
Mfd by: M/s. Rivpra
Formulation Pvt. Ltd.,
Plot No. 8, Sector -6A,
I.I.E. Sidcul, Haridwar –

Page 1 of 11
249 403 Uttarakhand.
5. Domperidone B. No.: T-2203139 Related Substances CDSCO CDTL
Tablets I.P. 10 Mfg dt: 03/2022 East Zone Kolkata
mg Exp dt: 02/2024 Kolkata
Mfd by: M/s. Rivpra
Formulation Pvt. Ltd.,
Plot No. 8, Sector -6A,
I.I.E. Sidcul, Haridwar –
249 403 Uttarakhand.
6. Gabapentin B. No.: 22S1GTB467 Related Substances CDSCO CDTL
Tablets I.P. Mfg dt: 11/2022 East Zone Kolkata
Exp dt: 10/2024 Kolkata
Mfd by: M/s. Synokem
Pharmaceuticals Ltd.,
Plot No. 35-36, Sector-
6A, I.I.E (SIDCUL),
Ranipur (BHEL),
Haridwar – 249 403,
Uttarakhand.
7. Gabon-300 B. No.: MT225040 Related Substances CDSCO CDTL
Tablets Mfg dt: 11/2022 East Zone Kolkata
(Gabapentin Exp dt: 10/2024 Kolkata
Tablets I.P.) Mfd by: M/s. Mascot
Health Series Pvt. Ltd.,
Plot No. 79, 80, Sec -
6A, I.I.E., (SIDCUL),
Haridwar – 249 403,
Uttarakhand, India.
8. Rolled Bandage B. No.: 637 Threads per dm CDSCO CDTL
(Non Sterilized, Mfg dt: 03/2022 (Warp & Weft), West Zone Kolkata
Size 15cm x 4 Exp dt: 02/2024 Weight in gm per m2 Mumbai
mts.) Mfd by: M/s. Disha & Fluorescence
Surgicals Pvt. Ltd., 145,
Sai Puram, Delhi Road,
Meerut - 250002
Uttar Pradesh.
9. Absorbent Cotton B. No.: 636 Surface Active CDSCO CDTL
Wool I.P. Mfg dt: 10/2022 Substances, Sinking West Zone Kolkata
Exp dt: 2 years from Time & Sulphated Mumbai
Mfd by: M/s. Jajoo ash
Surgicals Pvt. Ltd., Unit
1: 61A/62, Industrial
Area No. 3, A.B. Road,
Dewas -455001 (MP),

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India, Unit 2: 82-B-83C,
Industrial Area No. 1,
A.B. Road, Dewas –
455 001 (MP), India.
10. DACILON 0.5 B. No.: DMI2243AC Appearance CDSCO CDTL
(Dactinomycin for Mfg dt: 12/2022 & Hyderabad Kolkata
Injection USP Exp dt: 11/2025 Assay
0.5 mg) Mfd by: M/s. Celon
Laboratories Pvt. Ltd.,
Plot No.2, ALEAP
Industrial Estate,
Gajularamaram,
Medchal Dist. 500090,
Telangana State, India.
11. Rivastigmine B. No.: 20201201 Identification CDSCO CDTL
Tartarate Mfg dt: Nil Assay & Water Hyderabad Kolkata
Exp dt: Nil
Mfd by: M/s. Nil
12. Ritonavir B. No.: Nil Specific Optical CDSCO CDTL
Mfg dt: Nil, Rotation, Water Hyderabad Kolkata
Exp dt: Nil, Content, Related
Substances,
Mfd by: M/s. Nil
Identification, Assay
13. Iron and Folic B. No.: IQTZ-371 Description, Assay CDSCO CDTL
Acid Tablets I.P. Mfg dt: 12/2022 and Uniformity of Zonal Office Kolkata
Exp dt: 11/2024 Content of Folic Ahmedabad
Mfd by: M/s. Nestor Acid
Pharmaceuticals
Limited, 11, Western
Extension Area,
Faridabad – 121 001,
India.
14. (DUCOLAX) B. No.: 220259 Assay and CDSCO CDTL
Bisacodyl Tablet Mfg dt: 02/2022 Dissolution West Zone Kolkata
I.P. 5 mg Exp dt: 01/2025 Mumbai
Mfd by: M/s. Modi
Antibiotics, Plot No. 28,
G.I.D.C., Odhav,
Ahmedabad 382415,
Gujarat.
15. ALGLIMET M1 B. No.: AT22068 Assay and CDSCO CDTL
(Glimepiride 1 mg Mfg dt: 03/2022 Dissolution of West Zone Kolkata
& Metformin 500 Exp dt: 02/2024 Glimepiride Mumbai
mg Tablets SR) Mfd by: M/s. Alves
Healthcare Pvt. Ltd.,

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Nangal Uperia,
Swarghat Road,
Nalagarh, Distt. Solan –
174 101, Himachal
Pradesh, India
16. Meswak B. No.: BM0637 Total Bacterial CDSCO CDTL
(Toothpaste for Mfg dt: 07/2022 Count and Test for West Zone Kolkata
complete Tooth Exp dt: 07/2024 Pathogens Mumbai
and Gum Care) Mfd by: M/s. Dabur India
Limited, Village
Monakpur, Tehsil Baddi,
Dist.: Solan , Himachal
Pradesh –174 101
17. MEROXIA Nano B. No.: D220162 Assay of CDSCO CDL
Injection 1 gm Mfg dt: 01/2022 Meropenem South Zone Kolkata
(Meropenem Exp dt: 12/2023 & Chennai
Injection I.P.) Mfd by: M/s. Oscar Content of Sodium
Remedies Pvt. Ltd.,
Oskar House, Badi
Majra, Yamunanagar -
135 001,Haryana.
18. Vitamin B B. No.: RT-220598 Description and CDSCO CDL
Complex Tablets Mfg dt: 05/2022 Assay of Thiamine North Zone Kolkata
Exp dt: 10/2023 Hydrochloride Ghaziabad
Mfd by: M/s. Relief
Biotech Pvt. Ltd.,
Khasra No. 72, Makhyali
Dundi, Peerpura Road,
Roorkee Bypass, Delhi
Road, Manglour,
Roorkee - 247656,
Haridwar, Uttarakhand.
19. APVIL B. No.: RT220155 Assay of CDSCO CDL
(Pheniramine Mfg dt: 02/2022 Pheniramine East Zone Kolkata
Maleate Tablets Exp dt: 01/2025 Maleate Kolkata
I.P.)
Mfd by: M/s. Ridley Life
Science Pvt. Ltd., D-
1651, DSIDC, Indl.
Complex, Narela, Delhi
110040.
20. VASOCON 1 ml B. No.: KP85229 Description and Drug CDL
(Adrenaline Mfg dt: 07/06/2022 Particulate Matter Control Kolkata
Bitartrate Exp dt: 06/06/2023 Department
Injection I.P.) Mfd by: M/s. Neon Jammu

Page 4 of 11
Laboratories Ltd., At &
Shantisthal, Plot No. 1- Kashmir
5, At & post: Shirgaon,
Tal Palghar, Dist. Thane
- 401 407, Maharashtra.
21.. Hydrocort -100 B. No.: AQH0039 Clarity of Solution Drug CDL
(Hydrocortisone Mfg dt: 07/2022 Control Kolkata
Sodium Exp dt: 06/2024 Department
Succinate Mfd by: M/s. Aqua Vitoe Jammu
Injection I.P. Laboratories Plot No. 4, &
100 mg) Village Kunjhal near Kashmir
Jharmajri Baddi, Dist.
Solan 173205, Himachal
Pradesh, India.
22. Lycopene with B. No.: NL-22057 Assay of Vitamin E Drug RDTL
Vitamins and Mfg dt: 08/2022 Acetate. Control Chandigarh
Minerals Syrup Exp dt: 01/2024 Department
(CARORICH Mfd by: M/s. H.L. Himachal
Syrup) Healthcare Pvt. Ltd., Pradesh
Plot No. 25, Ind. Area,
Phase-II, Gagret-177
201, Himachal Pradesh.
23. Aceclofenac, B. No.: T-220621 Assay of CDSCO RDTL
Paracetamol and Mfg dt: 06/2022 Aceclofenac and North Zone Chandigarh
Thiocolchicoside Exp dt: 05/2024 Thiocolchicoside
Tablets (ELFEN- Mfd by: M/s. Vilin Bio
TH4 TABLETS) Med Ltd, Unit-II, Khasra
No. 85, Madhopur
Hazarathpur, Roorkee-
247667, Uttarakhand.
24. Vitamin C B. No.: JBJM-099 Assay of CDSCO RDTL
Injection IP and Mfg dt: 11/2022 Folic Acid. North Zone Chandigarh
Vitamin B12, Exp dt: 10/2024
Folic Acid and Mfd by: M/s. JBJM
Niacinamide Parenterals Pvt. Ltd,, P-
Injection 24, Site-5, UPSIDC
Industrial Area, Kasna,
(Eldervit-12)
Greater Noida-201310,
Uttar Pradesh.

25. Nirmatrelvir B. No.: (A) NR-2204 Uniformity of weight, Drug RDTL


Tablets 150 mg (B) RT- 2204 Identification and Control Chandigarh
and Ritonavir Mfg dt: 07/2022 Assay of Department
Tablets IP 100 Exp dt: 06/2024 Nirmatrelvir. Delhi
mg Combipack Mfd by: M/s. Neutral

Page 5 of 11
(Primovir Tablets) Code: HP/06/176,
Marketed by: Astrica
HealthCare Pvt Itd. Plot
No: 9-18/5, First Floor,
Bharathi Nagar, Temple
Alwal, Medchal,
Telangana-500010.
26. Vitamin C, B. No.: JE-07 Identification and CDSCO RDTL
Vitamin B12, Mfg dt: 12/2022 Assay of Folic Acid. North Zone Chandigarh
Folic Acid and Exp dt: 11/2024
Niacinamide Mfd by: M/s. SVP
Injection Lifesciences SARA
(Eldervit-12) Industrial Estate, Sector
C 10/1, Selaqui,
Rampur, Dehradun,
U.K.
27. Vitamin C, B. No.: RA2008 Assay of CDSCO RDTL
Vitamin B12, Mfg dt: 02/2022 Folic Acid Sub-Zone Chandigarh
Folic Acid and Exp dt: 01/2024
Nicotinamide Mfd by: M/s. Ronam
Injection (Eldervit Healthcare Pvt. Ltd.,
-12 Injection) Village - Kalujhanda,
Tehsil- Baddi, Distt.-
Solan (H.P.) 174103.
28. Vitamin C, B. No.: RA2156 Assay of CDSCO RDTL
Vitamin B12, Mfg dt: 12/2022 Folic Acid Sub-Zone Chandigarh
Folic Acid and Exp dt: 11/2024
Nicotinamide Mfd by: M/s. Ronam
Injection (Eldervit Healthcare Pvt. Ltd.,
-12 Injection) Village - Kalujhanda,
Tehsil- Baddi, Distt.-
Solan (H.P.) 174103.
29. Diphenhydramine B. No.: LDS2005AL Assay of Menthol CDSCO RDTL
HCl, Ammonium- Mfg dt: 12/2022 Sub-Zone Chandigarh
Chloride and Exp dt: 05/2024
Sodium Citrate Mfd by: M/s.
Cough HINDUSTAN
Expectorant LABORATORIES,
LIMITED, Plot No. 5-9,
Survey No. 38/2, Aliyali,
Palghar (W), Dist –
Palghar 401404,
Maharashtra.
30. Pre and Probiotic B. No.: HPH 207 Identification and CDSCO RDTL

Page 6 of 11
Capsules Mfg dt: 04/2022 Assay of North Zone Chandigarh
Exp dt: 02/2024 Streptococcus
Mfd by: M/s. Med Manor faecalis
Organics Pvt. Ltd., Unit-
II, K.No. 143M/7,
Village-Raipur,
Pargana- Bhagwanpur,
Tehsil- Roorkee, Distt.
Haridwar, Uttarakhand-
247 661.

31. Vitamin C B. No.: EP-0916 Particulate matter CDSCO RDTL


Injection IP and Mfg dt: 10/2022 North Zone Chandigarh
Vitamin B12, Exp dt: 09/2024
Folic Acid and Mfd by: M/s. E.G
Nicotinamide Pharmaceuticals, Vill.
Injection Mandhala, Teh. Kasauli
(Eldervit-12 Distt. Solan, Himachal
Injection) Pradesh.
32. Telmisartan 40 B. No.: 18220076 Dissolution of Drug RDTL
mg and Mfg dt: 01/2022 Telmisartan Control Chandigarh
Amlodipine 5 mg Exp dt: 12/2024 Department
Tablets IP Mfd by: M/s. Glenmark Delhi
(Telma-AM Pharmaceuticals Ltd.,
Tablets) Samlik Marchak,
Industrial Growth
Centre, East Sikkim,
Sikkim-737135.
33. Metronidazole B. No.: 3000421 Dissolution. CDSCO CDTL
Tablets IP 400 Mfg dt: 03/2021 Subzone Chennai
mg Exp dt: 02/2024 Bangalore
Mfd by: M/s. Karnataka
Antibiotics &
Pharmaceuticals Ltd.,
Plot No.14,
II Phase, Peenya,
Bengaluru-560058.
34. BACLOX-400 B. No.: AUT-22002 Dissolution CDSCO CDTL,
(Norfloxacin Mfg dt: 08/2022 West- Zone Mumbai
Tablets IP) Exp dt: 07/2025 Mumbai.
Mfd by: M/s. Supermax
Laboratories, Plot
No.40, Pharmacity
Selaqui Industrial Area,
Dehradun- 248011.

Page 7 of 11
35. ODIMONT-AL B. No.: GZOA22002 Assay and CDSCO CDTL,
(Montelukast, Mfg dt: 11/2022 Dissolution of West-Zone Mumbai
Levocetirizine Exp dt: 10/2024 Montelukast
HCl & Ambroxol
Mfd by: M/s. GKM New
HCl (SR)
Tablets) Pharma Spl. Type Plot
No. 5, 6, 7 & 8, Pipdic
Electronic Park,
Thirubuvanai
Puducherry- 605 107.

36. Voglibose Tablets B.No.: 1121-27 Test for Assay Sub-zone, CDTL,
IP 0.2mg Mfg dt: 10/2022 Indore Mumbai
Exp dt: 09/2024
Mfd by: M/s HAB
Pharmaceuticals &
Research Ltd., 10,
Pharmacity, SIDCUL,
Selaqui, Dehradun-
248011
37. Lactuedge B. No.: GA22005 Assay and Organic CDSCO CDTL,
(Lactulose Mfg dt: 02/2022 Impurities West-Zone Mumbai
Solution USP) Exp dt: 01/2024
Mfd by: M/s. Skymap
Pharmaceuticals Pvt.
Ltd., B-3, Dev Bhoomi
Industrial Estate,
Puhana Iqbalpur Road,
Roorkee- 247 667.
38. Albendazole B. No.: MS4AI2202 Dissolution Drug RDTL
Tablets IP Mfg dt: 09/2022 Control Guwahati
Exp dt: 08/2025 Department
Meghalaya
Mfd by: M/s. MAXTAR
BIO-GENICS,
Khasra No. 705, Vill.
Malku Majra, Nalagarh
Road , Baddi, Distt.
Solan – 173205,
Himachal Pradesh,
India.
39. Amoxycillin, B. No.: PRB-220203 Assay of Cloxacillin Drug RDTL
Cloxacillin & Mfg dt: 02/2022 Control Guwahati
Lactic Acid Exp dt: 01/2024 Department
Bacillus Capsules Jharkhand
Mfd by: M/s. Preet
Amoxynol Plus
Remedies Ltd.

Page 8 of 11
LB 183-186, HPSIDC,
Industrial Area, Baddi-
173205- Himachal
Pradesh.
40. Ascorbic Acid B. No.: T392012 Description Drug RDTL
Tablets IP 500mg Mfg dt: 01/2022 Control Guwahati
Exp dt: 12/2023 Department
Assam
Mfd by: M/s. ANG
Lifesciences India Ltd.
Village Malkumajra,
Nalagarh Road,
Baddi, Distt. Solan-
173205, Himachal
Pradesh.
41. CIPROFLOXACI B. No.: 0701122 Dissolution Drug RDTL
N Mfg dt: 05/2022 Control Guwahati
HYDROCHLORI Exp dt: 04/2025 Department
DE TABLETS I.P. Jharkhand
Mfd by: M/s.
500 mg
KARNATAKA
ANTIBIOTICS &
PHARMACEUTICALS
LIMITED, Plot No. 14, II
Phase, Peenya,
Bengaluru – 560 058.
42. Calcium & B. No.: RT-221004 Identification and Drug RDTL
Vitamin D3 Mfg dt: 10/2022 Assay of Vitamin D3 Control Guwahati
Tablets I. P. Exp dt: 03/2024 Department
Bihar
Mfd by: M/s. Relief
Biotech Pvt. Ltd.
Khasra No. 72, Makhyali
Dundi, Peerpura Road,
Roorkee, Byepass, Deli
Road, Manglour,
Roorkee-247656,
Haridwar, Uttarakhand.
43. Calcium & B. No.: T2030158A Assay of Drug RDTL
Vitamin D3 Mfg dt: 03/2022 Vitamin D3 Control Guwahati
Tablets I. P. Exp dt: 02/2024 Department
(Calcidoc-500) Jharkhand
Mfd by: M/s. ION
Healthcare Pvt. Ltd.
Baddi – Barotiwala
Road, Baddi,
Distt. Solan, Himachal
Pradesh - 173205.
44. Calcium & B. No.: RT-221008 Assay of Drug RDTL
Vitamin D3 Mfg dt: 10/2022 Vitamin D3 Control Guwahati
Tablets I.P. Exp dt: 03/2024 Department

Page 9 of 11
Mfd by: M/s. Relief Bihar
Biotech Pvt. Ltd.
Khasra No. 72, Makhyali
Dundi, Peerpura Road,
Roorkee Bypass, Delhi
Road, Manglour,
Roorkee-247656,
Haridwar, Uttarakhand.
45. O2 (Ofloxacin & B. No.: E20034 Identification and Drug RDTL
Ornidazole Mfg dt: 01/2022 Assay of Ofloxacin Control Guwahati
Tablets I.P.) Exp dt: 12/2024 & Ornidazole Department
Assam
Mfd by: M/s. Medley
Pharmaceutical Ltd.
Lane No. 3, Phase-1,
SIDCO Industrial
Complex, Bari
Brahmama, Jammu-
181133.
46. CIPROFLOXACI B. No.: KA3202 Dissolution Drug RDTL
N Mfg dt: 01/2022 Control Guwahati
HYDROCHLORI Exp dt: 12/2024 Department
DE TABLETS I.P. Jharkhand
Mfd by: M/s. Karnataka
500 mg
Antibiotics &
Pharmaceuticals
Limited, Plot No. 37,
Site No.34/4, NTTF
Main Road, II Phase,
Peenya, Bengaluru –
560058, India.
47. ALCIFLOX 500 B. No.: ACT22004SL Dissolution Drug RDTL
(Ciprofloxacin Mfg dt: 02/2022 Control Guwahati
Tablets I.P.) Exp dt: 01/2025 Department
Jharkhand
Mfd by: M/s. Shiva
Biogenetic Laboratories
Pvt. Ltd. village
Manpura, Baddi, Dist.
Solan, Himachal
Pradesh- 174101.
48. Telmisartan B. No.: T101004 Dissolution & Drug RDTL
Tablets IP 40 mg Mfg dt: 09/2021 Description Control Guwahati
Exp dt: 08/2023 Department
Bihar
Mfd by: M/s. ANG
Lifesciences India Ltd.
Village Malkumajra,
Nalagarh Road,
Baddi, Distt. Solan-
173205- Himachal
Pradesh.

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