Alembic Pharmaceuticals recalls Tobramycin Ophthalmic Solution 0.3% 5mL bottles due to failed impurities and degradation specifications. Rx only product with specific lot numbers and expiration dates.
Failed Impurities/Degradation Specifications
Alembic Pharmaceuticals is recalling Tobramycin Ophthalmic Solution 0.3% 5mL bottles because they may contain impurities or degrade improperly. This could pose a risk to users who need this medication for eye infections.
The product may contain impurities or degrade improperly, which could lead to harmful effects when used in the eye. This is a medication for eye infections, so improper quality could cause injury or illness.
People with a prescription for Tobramycin Ophthalmic Solution 0.3% 5mL bottles from Alembic Pharmaceuticals. Those using the product for eye infections are most at risk.
Check for the product name 'Tobramycin Ophthalmic Solution USP 0.3% 5mL', manufactured by Alembic Pharmaceuticals in Bedminster, NJ. Look for lot numbers AMR103 (expiring 10/2023) or AMR201 (expiring 06/2024).
Verify the product name, lot number, and expiration date to confirm if it's recalled.
The recall states the product may have impurities or degrade improperly, so it's not safe to use as recalled.
The recall does not specify a remedy, so contact your healthcare provider for advice.
Check for lot numbers AMR103 (expiring 10/2023) or AMR201 (expiring 06/2024) on the 5mL bottle.
We’ve drafted a message you can send Alembic Pharmaceuticals to request your refund or repair — edit it as you like.
Subject: Recall D-1086-2023 — Alembic Pharmaceuticals Alembic Pharmaceuticals Hello, I own a Alembic Pharmaceuticals that is covered by recall D-1086-2023 from Alembic Pharmaceuticals. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
