FDA Recall D-1086-2023
ALEMBIC PHARMACEUTICALS, INC. · Bedminster, NJ
Class III Ongoing 1022 days on record
Lower impact — Class III recall — product violates FDA labeling or manufacturing standards but is unlikely to cause adverse health consequences.
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
Recall record
- Recall number
D-1086-2023- Classification
- Class III
- Status
- Ongoing
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- Nationwide in the USA
- Recall initiated
- 2023-07-27
- Classified by FDA Center
- 2023-08-17
- FDA published
- 2023-08-23
- Recalling firm
- ALEMBIC PHARMACEUTICALS, INC.
- Firm location
- Bedminster, NJ
Drug identification
- Brand name(s)
- TOBRAMYCIN OPHTHALMIC SOLUTION
- Generic name(s)
- TOBRAMYCIN OPHTHALMIC SOLUTION
- Manufacturer(s)
- Alembic Pharmaceuticals Inc.
- NDC(s)
62332-518- Route(s)
- OPHTHALMIC
Operational response
Class III recalls are unlikely to cause adverse health consequences but indicate a violation of FDA labeling or manufacturing standards. Pull from active dispensing per your operational policy.
For the official FDA enforcement record, see FDA's Recall Search.