July 2023 FDA Recall Tobramycin Ophthalmic Solution by Alembic Pharmaceuticals, Inc.
D-1086-2023 - Failed Impurities/Degradation Specifications
This Class III drug recall was voluntarily initiated by Alembic Pharmaceuticals, Inc. on July 27, 2023 for the product Tobramycin Ophthalmic Solution. The FDA reported the reason for recall as failed impurities/degradation specifications. The product was distributed Nationwide and the recall is currently ongoing.
Recall Number: D-1086-2023
Failed Impurities/Degradation Specifications
07-27-2023
08-23-2023
82,400 bottles
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
ALEMBIC PHARMACEUTICALS, INC.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide in the USA
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Tobramycin Opthalmic Solution USP, 0.3%, 5mL bottle, Rx only, Manufactured for: Alembic Pharmaceuticals, Bedminster, NJ 07921, USA, NDC 62332-518-05
Batch or Lot Expiration Information
Lot# : AMR103, Exp: 10/2023
Lot# : AMR201, Exp: 06/2024
