Drug recall D-1086-2023

Class III Ongoing reported Aug 23, 2023

Product

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

Reason for recall

Failed Impurities/Degradation Specifications

Lots and codes

Lot #: AMR103, Exp: 10/2023; Lot#: AMR201, Exp: 06/2024

Recall details

Recalling firm
ALEMBIC PHARMACEUTICALS, INC., Bedminster, NJ
Quantity
82,400 bottles
Distribution
Nationwide in the USA
Type
Voluntary: Firm initiated
Recall initiated
July 27, 2023

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