Recalls / Class III
Class IIID-1086-2023
Product
Tobramycin Opthalmic Solution USP, 0.3%, 5mL bottle, Rx only, Manufactured for: Alembic Pharmaceuticals, Bedminster, NJ 07921, USA, NDC 62332-518-05
- Brand name
- Tobramycin Ophthalmic Solution
- Generic name
- Tobramycin Ophthalmic Solution
- Active ingredient
- Tobramycin
- Route
- Ophthalmic
- NDC
- 62332-518
- FDA application
- ANDA211847
- Affected lot / code info
- Lot #: AMR103, Exp: 10/2023; Lot#: AMR201, Exp: 06/2024
Why it was recalled
Failed Impurities/Degradation Specifications
Recalling firm
- Firm
- ALEMBIC PHARMACEUTICALS, INC.
- Manufacturer
- Alembic Pharmaceuticals Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 550 Hills Dr Ste 104b, Bedminster, New Jersey 07921-1537
Distribution
- Quantity
- 82,400 bottles
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2023-07-27
- FDA classified
- 2023-08-17
- Posted by FDA
- 2023-08-23
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-1086-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.