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Dareoct 19

The document reports the results of drug and cosmetic samples tested for quality standards by various laboratories in India for the month of October 2019. A total of 1163 samples were tested, with 1127 passing as meeting quality standards, 36 failing for not meeting standards, and none being found spurious or misbranded. The samples failing standards included various drugs like paracetamol tablets, albendazole tablets, and azithromycin oral suspensions. Reasons for failure included dissolution rates not being met and assay values outside the acceptable range.

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100 views6 pages

Dareoct 19

The document reports the results of drug and cosmetic samples tested for quality standards by various laboratories in India for the month of October 2019. A total of 1163 samples were tested, with 1127 passing as meeting quality standards, 36 failing for not meeting standards, and none being found spurious or misbranded. The samples failing standards included various drugs like paracetamol tablets, albendazole tablets, and azithromycin oral suspensions. Reasons for failure included dissolution rates not being met and assay values outside the acceptable range.

Uploaded by

spp
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 October2019

Total number of samples tested 1163


Total number of samples declared as of Standard Quality 1127
Total number of samples declared as Not of Standard Quality 36
Total number of samples declared as Spurious 0
Total number of samples declared as Misbranded 0

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


N. Drugs/medical Manufacture/Date of failure
device/cosmetics Expiry/Manufactured By
1. Paracetamol B. No.: 821481298, Dissolution Drugs RDTL,
Tablets I.P. Mfg dt: 03/2019, Control Guwahati
Exp dt: 02/2021, Department,
Mfd by: M/s. Bengal
Arunachal
Chemicals &
Pharmaceuticals Ltd. Pradesh
84/23, Factory Area,
Fazalganj, Kanpur-
208012, Uttar Pradesh.
2. Albendazole Tablets B. No.: 9410, Dissolution Drugs RDTL,
I.P.400 mg Mfg dt: 01/2017, Control Guwahati
Exp dt: 12/2019, Department,
Mfd by: M/s. Orissa
Nagaland
Drugs and Chemicals
Ltd. 1, Mancheswar,
Industrial Estate,
Bhubaneswar, Odisha.
3. Paracetamol Tablet B. No.: 821481296, Dissolution Drugs RDTL,
I.P. Mfg dt: 03/2019, Control Guwahati
Exp dt: 02/2021, Department,
Mfd by: M/s. Bengal
Arunachal
Chemicals &
Pharmaceuticals Ltd. Pradesh
84/23, Factory Area,
Fazalganj, Kanpur-
208012, Uttar Pradesh

4. Azithromycin Oral B. No.: L-1724703, Assay & pH Drugs RDTL,


Suspensions I.P. Mfg dt: 11/2017, Control Guwahati
100 mg Exp dt: 10/2019, Department,
Mfd by: M/s. Hanuchem
Arunachal
Laboratories V.P.O:
Manpura, Tehsil, Baddi, Pradesh
Dist-Solan-173205 (H.P.).
5. Ibuprofen Tablets B. No.: 01019-BJA36, Dissolution Drugs RDTL,
I.P. 400 mg Mfg dt: 01/2019, Control Guwahati
Exp dt: 12/2020, Department,
Mfd by: M/s. Biogenetic
Arunachal
Drugs Pvt. Ltd. Vill-
Jharmajri, Baddi, Dist- Pradesh
Solan H.P.-174103.

6. Moxiford Eye Drops B. No.: LHL-2692, Description & CDSCO, CDL,


(Moxifloxacin Eye Mfg dt: 08/2018, Assay North Zone, Kolkata
Drops I.P.) Exp dt: 07/2020, Ghaziabad
Mfd by: M/s. Park
Pharmaceuticals,
Vill.- Kalujhanda, Near
Nanakpura, Teh. Baddi,
Distt. Solan (H.P.) –
174103.
7. Tobotor Eye Drops B. No.: ETB-045, Uniformity of CDSCO, CDL,
5 ml (Tobramycin Mfg dt: 10/2018, Volume Hyderabad Kolkata
Sulphate Opthalmic Exp dt: 09/2020,
Mfd by: M/s. Appasamy
Solution)
Occular Devices (P) Ltd.,
Plot No. 74-D, Katha,
Baddi, Distt. Solan (H.P.)
– 173205.
8. CLEO Fresh B. No.: G2A06.530, Identification & CDSCO, CDL,
Glutathione 70000 Mfg dt: Not Stated Assay South Zone, Kolkata
mg Exp dt: 10/2021 Chennai
Mfd by: M/s. Laboratories
Filorga 75008, Paris
France.
9. CLEO Fresh B. No.: G2A05.529 Identification & CDSCO, CDL,
Glutathione 70000 Mfg dt: Not Stated Assay South Zone, Kolkata
mg Exp dt: 10/2019 Chennai
Mfd by: M/s. Laboratories
Filorga 75008, Paris
France

10. New Erythrocin 500 B. No.: MBD0214, Dissolution CDSCO, CDL,


(Erythromycin Mfg dt: 11/2018, East Zone, Kolkata
Stearate Tablets I.P. Exp dt: 04/2020, Kolkata
Mfd by: Medibios
500 mg)
Laboratories Pvt. Ltd.,
Plot No. J-76, MIDC
Tarapur, Boisar, Taluka:
Palghar, Distt. Thane -
401506
11. Erythrocin 500 B. No.: MBE0082 Dissolution CDSCO, CDL,
(Erythromycin Mfg dt: 05/2019 East Zone, Kolkata
Stearate Tablets I.P. Exp dt: 04/2021 Kolkata
Mfd by: M/s. Medibios
500 mg)
Laboratory Pvt. Ltd., Plot
No. J-76, MIDC Tarapur,
Palghar – 401506.
12. Ciprofloxacin B. No.: 2095 Dissolution CDSCO, RDTL,
Tablets IP 500 mg Mfg dt: 11/2019 North Zone, Chandigarh
Exp dt: 12/2021 Ghaziabad
Mfd by: Hindustan
Antibiotics Ltd. Pimpri,
Pune-411018,
Maharashtra, India
13. Betamethasone B. No.: RD459 Assay Drugs RDTL,
Dipropionate Cream Mfg dt: 04/2019 Control Chandigarh
IP Exp dt: 03/2021 Office,
Mfd by: Curetech
Rohtak.
Skincare Plot No.33-34,
Phase-IV, Bhatoli Kalan,
Baddi-173205, Distt.
Solan (HP).
14. Amoxycillin and B. No.: TG19-32 Dissolution CDSCO, RDTL,
Potassium Mfg dt: 07/2019 and Assay Sub Zone, Chandigarh
Clavulanate Tablets Exp dt: 12/2020 Baddi
Mfd by: GNB Medica
IP (ICLAVE-625
Labs Village Neehli
TABLETS ) Dhang, Jagat Khana,
Tehsil Nalagarh, Distt,
Solan (H.P.)-174101

15. Atorvastatin Tablets B. No.: RLT-005 Dissolution CDSCO, RDTL,


IP 10 Mg Mfg dt: 11/2018 North Zone, Chandigarh
Exp dt: 10/2020 Ghaziabad
Mfd by: Revat
Laboratories Pvt. Ltd 12-
321.Opp. I.D.A, Kurnool
Road, Pernamitta,
Ongole-523002, Andhra
Pradesh

16. Cefixime Dispersible B. No.: TF19-88 Uniformity of CDSCO, RDTL,


Tablets (SAMCEF- Mfg dt: 06/2019 dispersion and Sub Zone, Chandigarh
200DT TABLETS) Exp dt: 05/2021 Disintegration Baddi
Mfd by: GNB Medica
Labs Village Neehli
Dhang, Jagat Khana,
Tehsil Nalagarh, Distt,
Solan (H.P.)-174101

17. Luliconazole 1 % B. No.: 393 Assay CDSCO, RDTL,


w/w Cream Mfg dt: 05/2019 Sub Zone, Chandigarh
(LUZOLE) Exp dt: 04/2021 Baddi
Mfd by: Algen Healthcare
Limited 134/2, Vill. Khara
Khari, Sadhaura Road,
Kala Amb, Distt. Sirmour
H.P.-173030

18. Calcium Carbonate B. No.: CBRT-1041 Uniformity of CDSCO, RDTL,


Tablets IP Mfg dt: 04/2019 weight North Zone, Chandigarh
Exp dt: 03/2021
Mfd by: Wings Biotech 43 Ghaziabad
& 44 HPSIDC Industrial
Area, Baddi-173205, H.P

19. Albendazole Tablets B. No.: RALB-1841 Uniformity of CDSCO, RDTL,


IP 400 mg Mfg dt: 06/2018 weight North Zone, Chandigarh
Exp dt: 05/2020 Ghaziabad
Mfd by: Revat
Laboratories Pvt. Ltd 12-
321. Opp. I.D.A, Kurnool
Road, Pernamitta,
Ongole-523002,
Andhra Pradesh.

20. Clindamycin B. No.: 08073 Assay CDSCO, RDTL,


Phosphate Gel USP Mfg dt: 06/2018 Sub Zone, Chandigarh
1% w/w Exp dt: 05/2020 Jammu
Mfd by: Rhydburg
Pharmaceuticals Ltd. C-2
& 3, S.I.E.I, Seaqui,
Dehradun, Uttarakhand,
India

21. Amoxycillin and B. No.: TG19-36 Assay CDSCO, RDTL,


Potassium Mfg dt: 07/2019 Sub Zone, Chandigarh
Clavulanate with Exp dt: 12/2020 Baddi
Mfd by: GNB Medica
Lactic Acid Bacillus
Labs Village Neehli
Tablets (ANUMOX- Dhang, Jagat Khana,
CV-LB TABLETS) Tehsil Nalagarh, Distt,
Solan (H.P.)- 174101

22. Metformin B. No.: M500SRT-1901 Assay CDSCO, RDTL,


Hydrochloride Mfg dt: 01/2019 Sub Zone, Chandigarh
Sustained release Exp dt: 12/2020 Baddi
Mfd by: Titanes Pharma,
Tablets IP
Vill, Bathu, Tehsil Haroli,
(MEFMED-SR 500 Distt. Una (H.P)-174507
TABLETS)
23. Clobetasol B. No.: PCF901A Identification Drugs RDTL,
Propionate, Mfg dt: 02/2019 Control Chandigarh
Neomycin Sulphate Exp dt: 01/2021 Office,
Mfd by: Macleods
and Miconazole N.C.T Delhi
Pharmaceuticals Ltd.
Nitrate Cream Khasra No. 21, 22, 66, 67
(PANDERM & 68, Aho-Yangtam,
++CREAM) Namchepung, PO:
Ranipool, Sikkim-737135.

24. Betamethasone and B. No.: NG980 Identification of Drugs RDTL,


Clioquinol Cream Mfg dt: 04/2019 Betamethasone Control Chandigarh
BP (BETNOVATE-C Exp dt: 03/2021 Valerate eq. to Office,
Mfd by: GlaxoSmithKline
SKIN CREAM) Betamethasone N.C.T Delhi
Pharmaceuticals Limited
A-10, M.I.D.C., Ambad- & Assay of
Pathardi Block, Nashik- Clioquinol
422010, Maharashtra,
India

25. Betamethasone B. No.: EZ277 Identification Drugs RDTL,


Valerate and Mfg dt: 01/2019 Betamethasone Control Chandigarh
Neomycin Skin Exp dt: 06/2020 Valerate and Office,
Mfd by: GlaxoSmithKline
Cream Neomycin N.C.T Delhi
Pharmaceuticals Limited,
(BETNOVATE-N At: Plot No. C-1, Sulphate
CREAM) Madkaim Industrial
Estate, Madkaim, Post
Mardol, Ponda, Goa
403404.
26. Amikacin Sulphate B. No.: CLI-6868 Particulate CDSCO, RDTL,
Injection IP Mfg dt: 11/2018 Matter North Zone, Chandigarh
(AMIKACARE 500 ) Exp dt: 10/2020 Ghaziabad
Mfd by: Caremax
Formulations Plot No. 56
& 61, Industrial Area,
Phase III, Sansarpur
Terrace, Distt. Kangra
(H.P.)-176501

27. Ondansetron Oral B. No.: GNSG3-18-227 Assay CDSCO, Port CDTL,


Solution IP Mfg dt: 02/2019 Office, Chennai
Exp dt: 01/2021 Visakhapatnam
Mfd by: Ornate Labs Pvt.
Ltd., Bela Industrial
Estate, Muzaffarpur -
842005, Bihar

28. Compound Sodium B. No.: 2198 Description & CDSCO, CDTL


Lactate Injection IP Mfg dt: 01/2019 Sterility South Zone, Chennai
(Ringers Lactate Exp dt: 12/2021 Chennai
Mfd by: Hindustan
Solution for
Antibiotics Ltd., Pimpri,
Injection) Pune-411018,
Maharashtra, India
29. Levodopa & B. No.: AU49 Description & CDSCO, CDTL
Carbidopa Tablets Mfg dt: 12/2018 Assay of South Zone, Chennai
IP Exp dt: 11/2020 Levodopa & Chennai
Mfd by: Eurokem
Carbidopa
Laboratories Pvt. Ltd., C-
25, SIDCO
Pharmaceuticals
Complex, Alathur,
Thiruporur-603110
30. Lansoprazole Ph. B. No.: T9004141 Test for Water CDSCO, CDTL,
Eur Mfg dt: 03/2019 West Zone, Mumbai
Exp dt: 05/2023 Mumbai
Mfd by: M/s. Lupin Ltd.,
T-142, MIDC, Tarapur,
Boisar, Palghar-401506
31. Atorvastatin B. No.: 19SGBT032 Dissolution CDSCO, CDTL,
Calcium Tablets IP Mfg dt: 02/2019 Sub Zone, Mumbai
40mg Exp dt: 01/2021 Indore
Mfd by: M/s. Synokem
Pharmaceutical Ltd., Plot
No.-35-36, Sector-6A,
Integrated industrial
Estate (SIDCUL),
Ranipur (BHEL),
Haridwar -249403,
Uttarakhand
32. Moxileb Oral B. No.: BS169 Assay CDSCO, CDTL,
Suspension Mfg dt: 09/2019 West Zone, Mumbai
(Amoxicillin Oral Exp dt: 08/2021 Mumbai
Mfd by: M/s. Leben
Suspension BP)
Laboratories Pvt. Ltd.,
Plot No. L-4, Phase-III,
MIDC Akola-444104
Maharashtra.
33. Enaril (Enalapril B. No.: T-17395 Assay & CDSCO, CDTL,
Maleate Tablets I.P. Mfg dt: 07/2018 Dissolution West Zone, Mumbai
5mg) Exp dt: 06/2020 Mumbai
Mfd by: M/s. Jackson
Laboratories pvt. Ltd.,
Bye Pass, Majitha Road,
Amritsar 143001, Punjab
34. Furosemide B. No.: AV-4275 Sterility CDSCO, CDTL,
Injection I.P. 20mg / Mfg dt: 05/2019 West Zone, Mumbai
2ml Exp dt: 04/2021 Mumbai
Mfd by: M/s. Alpa
Laboratories Ltd., 33/2.
A.B. Road, Pigdamber
453446, Indore, Madhya
Pradesh
35. Ramipril Tablts IP B. No.: STN-181394A Assay CDSCO, CDTL,
2.5mg Mfg dt: 12/2018 Sub Zone, Mumbai
Exp dt: 11/2020 Indore
Mfd by: M/s. Terrace
Paharmaceuticals (P)
Ltd., 3-B (a), Phase-III,
Industrial Area,
Sansarpur terrace, Distt.
Kangra (H.P.) 176501

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