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Tetracycline Hydrochloride

TRACKED

Tetracycline-class Antimicrobial

CASHSN
THERAPEUTIC AREAS
MOLECULE INTELLIGENCE SNAPSHOTlive
14
Manufacturers monitored
38
Intelligence briefs
3
Active regulatory actions
₹2,800 Cr
Est. India export value

INTELLIGENCE

Showing 2 of 2 briefs for Tetracycline Hydrochloride
REGULATORY INTELLIGENCE·Recall

Avet Pharmaceuticals' Class I Recall of Tetracycline HCL Capsules Signals Critical Quality Control Gaps

Avet Pharmaceuticals initiated a Class I recall for 4,444 bottles of Tetracycline HCL Capsules, 250 mg, due to failed dissolution specifications during long-term testing. This event, terminated in August 2022, highlights significant quality control deficiencies impacting drug efficacy and patient safety, necessitating immediate action for procurement and regulatory teams to reassess supplier quality assurance protocols for essential generic antibiotics.

90-Day Activity
CMCatherine Morrow· Senior Regulatory Intelligence Analyst
2020-04-15 Recall
REGULATORY INTELLIGENCE·Recall

FDA Class I Recall: Avet Pharmaceuticals' Tetracycline HCL Capsules Fail Dissolution

Avet Pharmaceuticals, Inc. faced a Class I FDA recall for 17,524 bottles of Tetracycline HCL Capsules, USP, 500 mg, due to failed dissolution specifications during long-term testing. This nationwide recall, initiated on March 23, 2020, underscores critical quality control requirements for generic pharmaceuticals. Procurement and regulatory teams must assess supplier stability data and ensure robust quality agreements to mitigate supply chain disruptions.

90-Day Activity
CMCatherine Morrow· Senior Regulatory Intelligence Analyst
2020-04-15 Recall