Tobramycin Ophthalmic Solution recalled for failed quality specifications
Alembic Pharmaceuticals is recalling 82,400 bottles of Tobramycin Ophthalmic Solution nationwide because the product failed to meet impurities and degradation specifications.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class III recall for failed quality specifications with no reported illnesses or injuries. Class III recalls are typically lower severity, and this represents a precautionary quality-control recall.
Plain-English summary
Alembic Pharmaceuticals, Inc. is recalling Tobramycin Ophthalmic Solution USP 0.3%, 5 mL bottles because the product failed to meet impurities and degradation specifications. The recall affects 82,400 bottles distributed nationwide in the United States. The affected lots are AMR103 (expiration 10/2023) and AMR201 (expiration 06/2024). The FDA has classified this as a Class III recall.
Persons who have purchased or received affected lots should contact Alembic Pharmaceuticals, their pharmacist, or their healthcare provider for more information about this recall. Patients currently taking medication from affected lots should consult their healthcare provider about whether to continue use of their current supply.
The recalled product
- Product
- TOBRAMYCIN OPHTHALMIC SOLUTION (TOBRAMYCIN OPHTHALMIC SOLUTION)
- Brand
- TOBRAMYCIN OPHTHALMIC SOLUTION
- Manufacturer
- ALEMBIC PHARMACEUTICALS, INC.
- Category
- Drug — Ophthalmic
- Affected units
- 82,400
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Lot #: AMR103
- Exp: 10/2023
- Lot#: AMR201
- Exp: 06/2024
Distribution
Distributed nationwide across the United States.
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