Drug alert: 28 out of 1302 samples declared as NSQ in May 2023

Download the list of NSQ samples for May 2023, the link is given below:

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NSQ Drugs Substandard drugs Fail samples NSQ Samples Substandard samples
NSQ Drugs

Last Updated on January 6, 2024 by The Health Master

Download the list of NSQ samples for May 2023, the link is given below: The Central Drugs Standard Control Organisation (CDSCO) has declared 27 drug samples out of a total of 1302 drug samples tested as not of standard quality (NSQ) and none as misbranded and one spurious during the month of May 2023.

NSQ List is given below

Out of the 1302 samples tested during the month, 1274 samples came out with standard quality, while 27 samples were declared as not of standard quality (NSQ) & none declared as misbranded, and one as spurious.

Laboratory Research Testing Flask Chemistry
Picture: Pixabay

None of the samples were identified as adulterated however one declared as spurious during the month. Every month, the drug regulator comes up with a list of drugs, medical devices, and cosmetics that are declared not of standard quality / spurious / adulterated / misbranded, every month.

During the month of April 2023, the authorities tested 895 samples, out of which 859 samples were tested as of standard quality. The number of samples declared as not of standard quality was 35 and none as misbranded and one as spurious.

During the month of March 2023, the authorities tested 1497 samples, out of which 1149 samples were tested as of standard quality. The number of samples declared as not of standard quality was 48 and none as misbranded and none as spurious.

During the month of February 2023, the authorities tested 1251 samples, out of which 1192 samples were tested as of standard quality. The number of samples declared as not of standard quality was 59 and none as misbranded and none as spurious.

During the month of January 2023, the authorities tested 1348 samples, out of which 1281 samples were tested as of standard quality. The number of samples declared as not of standard quality was 67 and none as misbranded and none as spurious.

During the month of December 2022, the authorities tested 1375 samples, out of which 1305 samples were tested as of standard quality. The number of samples declared as not of standard quality was 70 and none as misbranded and none as spurious.

During the month of November 2022, the authorities tested 1487 samples, out of which 1404 samples were tested as of standard quality. The number of samples declared as not of standard quality was 83 and none as misbranded and none as spurious.

During the month of October 2022, the authorities tested 1280 samples, out of which 1230 samples were tested as of standard quality. The number of samples declared as not of standard quality was 50 and none as misbranded and none as spurious.

During the month of September, 2022, the authorities tested 1456 samples, out of which 1397 samples were tested as of standard quality. The number of samples declared as not of standard quality was 59 and none as misbranded and none as spurious.

During the month of August, 2022, the authorities tested 1330 samples, out of which 1285 samples were tested as of standard quality. The number of samples declared as not of standard quality was 45 and none as misbranded and none as spurious.

During the month of July, 2022, the authorities tested 1337 samples, out of which 1283 samples were tested as of standard quality. The number of samples declared as not of standard quality was 53 and one as misbranded and none as spurious.

The test samples were drawn by the zonal and sub-zonal offices of CDSCO, and tested in the drug testing laboratories i.e CDL, CDTLs & RDTLs in Kolkata, Mumbai, Hyderabad, Chandigarh, and Guwahati.

 


List of Drugs declared as Not of Standard Quality/Spurious/Adulterated/Misbranded for the Month of May– 2023.

S.NoName of Drugs/medical device/cosmeticsBatch No./Date of Manufacture/Date of Expiry/Manufactured ByReason for failureDrawn ByFrom
1.Heparin Injection I.P. 25000 IU / 5mlB. No.: 22HE17 Mfg dt: 10/2022 Exp dt: 09/2024 Mfd by: M/s. Sai Parenterals Ltd., D1 & D4, Survey No. 280, Phase-V, IDA, Jeedimetla, Hyderabad 500055, Telangana.AssayCDSCO Zonal Office HyderabadCDL Kolkata
2.Bupivacaine Heavy (Bupivacaine Hydrochloride in Dextrose Injection USP 4 ml),B. No.: I-5319 Mfg dt: 10/2022 Exp dt: 09/2024 Mfd by: M/s. Jackson Laboratories Pvt. Ltd., 22-24, Majitha Road, Bye Pass, Amritsar – 143 001 (India). Punjab.Description Foreign and Particulate matterDrug Control Department Jammu & KashmirCDL Kolkata
3.Doxycycline Hydrochloride Capsules IP 100 mgB. No.: DEC2215 Mfg dt: 10/2022 Exp dt: 09/2024 Mfd by: M/s. Modern Laboratories, 45-47, Sector D-2, Sanwer Road, Indore, Madhya Pradesh – 452 015, India,AssayCDSCO AhmedabadCDL Kolkata
4.Gentamicin (Gentamicin Injection I.P.) – 2 mlB. No.: GM22242 Mfg dt: 07/2022 Exp dt: 06/2024 Mfd by: M/s. Nandani Medical Laboratories Pvt. Ltd., 221/5, Bicholi Hapsi, Kanadia Road, Indore.Description and Particulate MatterCDSCO South Zone ChennaiCDL Kolkata
5.Misoprostol Tablets I.P. 200 mcgB. No.: 22HT303 Mfg dt: 11/2022 Exp dt: 10/2024 Mfd by: M/s. Accent Pharmaceuticals & Diagnostics, Village Bhalon (Seri), Forest Road, Solan – 173 212, Himachal Pradesh.AssayCDSCO South Zone ChennaiCDL Kolkata
6.Doxycycline Capsules IPB. No.: AC22031 Mfg dt: 10/2022 Exp dt: 09/2024 Mfd by: M/s. Alves Healthcare Private Limited, Nangal Uperla, Swarghat Road, Tehsil: Nalagarh, Distt. Solan -174101, Himachal Pradesh. India.AssayCDSCO South Zone ChennaiCDL Kolkata
7.Teripil -80 (Telmisartan Tablets I.P.)B. No.: STN-221142 Mfg dt: 11/2022 Exp dt: 10/2024 Mfd by: M/s. Terrace Pharmaceuticals (P) Ltd., 3-B(a) Phase – III, Industrial Area, Sansarpur Terrace, Distt. Kangra, Himachal Pradesh- 176501.DissolutionCDSCO East Zone KolkataCDL Kolkata
8.Ofloxacin & Ornidazole Tablets IPB. No.: 2618015 Mfg dt: 01/2023 Exp dt: 12/2024 Mfd by: M/s. Bengal Chemical and Pharmaceuticals Ltd, 164, Maniktala Main Road, Kolkata – 700 054.DescriptionCDSCO East Zone KolkataCDL Kolkata
9.Tinvista 300 (Tinidazole Tablets I.P. 300 mg)B. No.: JKGJ20001 Mfg dt: 03/2020 Exp dt: 02/2024 Mfd by: M/s. Cadila Pharmaceuticals Limited, Industrial Growth Centre, SIDCO, Samba – 184 121, State of Jammu & K.ashmir.DisintegrationCDSCO East Zone KolkataCDL Kolkata
10.Heparin Sodium Injection IP 5000 IU / 5mlB. No.: AIG-9415 Mfg dt: 05/2022 Exp dt: 04/2024 Mfd by: M/s. Alliaance Biotech, 440/3, Vill. Katha, Baddi, Distt. Solan, Himachal Pradesh – 173205.Description, Identification & Particulate Matter, Assay (Sample is deemed to be Spurious)Drug Control Department OdishaCDL Kolkata
11.AMOXICILLIN CAPSULES IP (ALMOX-500)B. No.: 22281692 Mfg dt: 07/2022 Exp dt: 06/2024 Mfd by: M/s. Alkem laboratories Ltd., At. Village-Thana, Tehsil- Baddi, Dist. Solan, Himachal Pradesh- 173205.AssayCDSCO Zonal Office HyderabadCDTL Hyderabad
12.ENALAPRIL MALEATE TABLETS IP 2.5mg (LAPRIL)B. No.: GB21113 Mfg dt: 12/2021 Exp dt: 11/2023 Mfd by: M/s. ORTIN LABORATORIES LTD, 275 & 278, (part)/I.D.A. Pashamylaram- 502307, Sanga Reddy, Dist. T.S. Telangana India.AssayCDSCO Zonal Office HyderabadCDTL Hyderabad
13.Rabeprazole Sodium and Domperidone TabletsB. No.: RT220468 Mfg dt: 05/2022 Exp dt: 04/2024 Mfd by: M/s. RIDLEY LIFE SCIENCE PVT. LTD., D-1651, DSIDC, Indl. Complex, Narela, Delhi-110040.DescriptionDrug Control Department MeghalayaRDTL Guwahati
14.LECET M Tablets (Levocetirizine Dihydrochloride, Montelukast Sodium Tablets I.P.)B. No.: INT-3551B Mfg dt: 05/2022 Exp dt: 04/2024 Mfd by: M/s. Instant Remedies Pvt. Ltd. An ISO 9001: 2015 & GMP Certified Company) V.P.O. Gholu, Majra, Dappar- 140507, Punjab.Dissolution of Montelukast Levocetirizine DihydrochlorideDrug Control Department JharkhandRDTL Guwahati
15.CLAVAM 625 (Amoxicillin And Potassium Clavulanate Tablets I.P.)B. No.: 22442372 Mfg dt: 08/2022 Exp dt: 01/2024 Mfd by: M/s. ALKEM HEALTH SCIENCE, A unit of Alkem Laboratories Limited, Unit-2, Samardung Karek Block, P.O.: Namthang, South Sikkim- 737137.Identification of Clavulanic Acid and Assay of Amoxicillin and Clavulanic AcidDrug Control Department BiharRDTL Guwahati
16.Paracetamol Tablets IP 500 mg (Galpara)B. No.: GPT22002 Mfg dt: 07/2022 Exp dt: 06/2025 Mfd by: M/s. Galpha Laboratories Limited, Village – Thana, Baddi, Himachal Pradesh – 173205.DissolutionDrug Control Department MeghalayaRDTL Guwahati
17.Paracetamol Tablets I.P. 500 mgB. No.: DGT22-270 Mfg dt: 06/2022 Exp dt: 05/2024 Mfd by: M/s. ORNATE LABS PVT. LTD. Bela Industrial Area, Muzaffarpur – 842005, Bihar.DissolutionDrug Control Department BiharRDTL Guwahati
18.Spasom-40 Capsules (Omeprazole Capsules I. P.B. No.: SRGC-22051 Mfg dt: 02/2022 Exp dt: 01/2024 Mfd by: M/s. SPAS Remedies (An ISO 9001, GMP & WHO-GMP Certified Unit),Vill- Bersan, P.o.- Lodhi Majra, Teh. Baddi, Distt. Solan, Himachal Pradesh- 173205Assay of OmeprazoleDrug Control Department BiharRDTL Guwahati
19.MONAMOX-CL 625 (Amoxycillin& Potassium Clavulanate Tablets I.P.)B. No.: 422-1199 Mfg dt: 08/2022 Exp dt: 01/2024 Mfd by: M/s. Zee Laboratories Ltd., Behind 47, Industrial Area, Paonta Sahib- 173 025. Himachal Pradesh .Assay and DissolutionCDSCO West-Zone Mumbai.CDTL, Mumbai
20.Probiotic CapsulesB. No.: PTC/C/003 Mfg dt: 01/2022 Exp dt: 12/2023 Mfd by: M/s. UNIQUE BIOTECH LTD., Plot No.2, Phase-II, MN Park, Kolthur Village, Shameerpet Mandal, Medchal Malkajgiri Dist. Hyderabad- 500101, Telangana, India.Identification and Assay of Streptococcus faecalisCDSCO North Zone GhaziabadRDTL Chandigarh
21.Paracetamol, Phenylphrine Hydrochloride, Diphenhydramine Hydrochloride and Caffeine Tablets (Syscold Tablets)B. No.: SPT-192 Mfg dt: 01/2022 Exp dt: 12/2023 Mfd by: M/s. Signoret Pharmaceuticals Pvt. Ltd., Plot No-556, Industrial Area, Phase IX, SAS Nagar-160059 Punjab.Disintegration test and Assay of Phenylephrine HydrochlorideDrug Control Department Himachal PradeshRDTL Chandigarh
22.Nimesulide and Paracetamol Tablets (Nimfed Tablets)B. No.: CMT22-666 Mfg dt: 09/2022 Exp dt: 08/2024 Mfd by: M/s. Cortex Medical Inc., Plot No.- 3F, Apperal Park, Katha, Industrial Area Baddi-173205, Distt. Solan, Himachal Pradesh.Disintegration testDrug Control Department Himachal PradeshRDTL Chandigarh
23.Paracetamol Oral Suspension IP (Paragus 250 Suspension)B. No.: CL30476 Mfg dt: 02/2023 Exp dt: 01/2025 Mfd by: M/s. Cosmas Pharmacls Ltd., Buranwala Road, Village: Kotla, P.O.: Barotiwala, Solan (H.P.)-1741003.Assay of ParacetamolDrug Control Department Himachal PradeshRDTL Chandigarh
24.Loperamide Hydrochloride Tablets IP (DYRIA STOP TABLETS)B. No.: DY-2214 Mfg dt: 02/2023 Exp dt: 01/2025 Mfd by: M/s. Cyper Pharma, K.No. 825- 827, Village Gullarwala, Sai Road, Baddi, Tehsil Nalagarh, Distt. Solan, Himachal Pradesh- India.Dissolution of Loperamide HydrochlorideDrug Control Department Himachal PradeshRDTL Chandigarh
25.Chlorpheniramine Maleate Tablets IP 4 mgB. No.: CPM2205 Mfg dt: 12/2022 Exp dt: 11/2024 Mfd by: M/s. CYPER PHARMA, K.No. 825- 827, Village Gullarwala, Sai Road, Baddi, Tehsil Nalagarh, Distt. Solan (H.P.)-173205 INDIA.Assay of Chlorpheniramine MaleateDrug Control Department Himachal PradeshRDTL Chandigarh
26.Glimepiride Tablets IP 2 mgB. No.: T192009 Mfg dt: 05/2022 Exp dt: 04/2024 Mfd by: M/s. ANG Lifesciences India Ltd., Village Malkumajra, Nalagarh Road, Baddi, Distt. Solan-173205, Himachal Pradesh.Dissolution of GlimepirideCDSCO Sub-Zone JammuRDTL Chandigarh
27.Doxycycline and Lactic Acid Bacillus Capsules (DOXYFIL-LB CAPSULES)B. No.: DXF-2103 Mfg dt: 03/2022 Exp dt: 02/2024 Mfd by: M/s. CYPER PHARMA, K.No. 825- 827, Gullarwala, Sai Road, Baddi, Tehsil Nalagarh, Distt. Solan, Himachal Pradesh – 173205 INDIA.Identification and Assay of Lactic Acid Bacillus.Drug Control Department Himachal PradeshRDTL Chandigarh
28.Cefixime and Ofloxacin Tablets (ZENCEF-O TABLETS)B. No.: ZFO-2101 Mfg dt: 03/2022 Exp dt: 02/2024 Mfd by: M/s. CYPER PHARMA, K.No. 825- 827, Gullarwala, Sai Road, Baddi, Tehsil Nalagarh, Distt. Solan, Himachal Pradesh – 173205 INDIA.Assay of Cefixime Trihydrate Calculated as anhydrous CefiximeDrug Control Department Himachal PradeshRDTL Chandigarh

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