FDA-Drug2023-08-23Class III

Tobramycin Opthalmic Solution USP, 0.3%, 5mL bottle, Rx only, Manufactured for: Alembic Pharmaceuticals, Bedminster, NJ 07921, USA, NDC 62332-518-05

ALEMBIC PHARMACEUTICALS, INC.
Hazard

Failed Impurities/Degradation Specifications

Sold states
Nationwide in the USA
Affected count
82,400 bottles
Manufactured in
550 Hills Dr Ste 104b, Bedminster, NJ, United States
Products
Tobramycin Opthalmic Solution USP, 0.3%, 5mL bottle, Rx only, Manufactured for: Alembic Pharmaceuticals, Bedminster, NJ 07921, USA, NDC 62332-518-05

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1086-2023

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