Status
Ongoing
Drug Enforcement D-1086-2023
Failed Impurities/Degradation Specifications
Classification
Class III
Report Date
August 23, 2023
Termination Date
—
Product Information
- Product description
- Tobramycin Opthalmic Solution USP, 0.3%, 5mL bottle, Rx only, Manufactured for: Alembic Pharmaceuticals, Bedminster, NJ 07921, USA, NDC 62332-518-05
- Product quantity
- 82,400 bottles
- Reason for recall
- Failed Impurities/Degradation Specifications
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide in the USA
Location & Firm
- Recalling firm
- ALEMBIC PHARMACEUTICALS, INC.
- Address
-
550 Hills Dr Ste 104b
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-1086-2023
- Event ID
- 92811
- Recall initiation date
- July 27, 2023
- Center classification date
- August 17, 2023
- Code info
- Lot #: AMR103, Exp: 10/2023; Lot#: AMR201, Exp: 06/2024
- More code info
- —