Manufacturer record
Macin Remedies India Ltd. B-21: regulatory record
Last checked 3 November 2026. Source: CDSCO monthly NSQ alerts and state drug-testing laboratories
1 batch manufactured by Macin Remedies India Ltd. B-21 was declared Not of Standard Quality in May 2025. Records are batch-specific findings by government laboratories as published in CDSCO's monthly alerts; where a company has stated that a flagged batch was counterfeit, that statement is noted when reported.
Most recent flagged batch: W373, Amikacin Sulphate Injection IP 500mg (Amikablast 500 Injection) (exp Jun 2025). A.S Kambli Palghar-Zone-1 FDA, Lab Mumbai (state lab) found it not of standard quality: The content of Amikacin in the sample is more (i.e 183.99% of the lablled amount) than the I.P limits. Listed in the May 2025 alert.
Records by type
1 record linked to Macin Remedies India Ltd. B-21 in the datasets we hold. A zero means nothing is on record in those datasets, not that nothing ever happened. What the labels mean.
CDSCO drug alerts: Not of Standard Quality and spurious drugs
Scope. A company appearing here is not a finding that its products are unsafe. Regulatory actions can apply to one batch, one formulation, one period or one state. Always check the linked government document for the current position, and tell us if something is out of date. How we label records.
Flagged batches per year
All flagged batches
| Product | Batch | Reason declared NSQ | Tested by | Alert |
|---|---|---|---|---|
| Amikacin Sulphate Injection IP 500mg (Amikablast 500 Injection) | Batch W373Mfg Jul 2023 · Exp Jun 2025 | The content of Amikacin in the sample is more (i.e 183.99% of the lablled amount) than the I.P limitsOther | A.S Kambli Palghar-Zone-1 FDA, Lab MumbaiState lab | May 2025 |
Right of reply. Manufacturers may submit a response or a laboratory re-test result; it is published unedited alongside this record. Submit a response.