Why it was recalled
Failed Impurities/Degradation Specifications
Product description
Tobramycin Opthalmic Solution USP, 0.3%, 5mL bottle, Rx only, Manufactured for: Alembic Pharmaceuticals, Bedminster, NJ 07921, USA, NDC 62332-518-05
Lot numbers, UPCs & expiration codes
Lot #: AMR103, Exp: 10/2023; Lot#: AMR201, Exp: 06/2024
Where it was sold
Nationwide in the USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1086-2023
- Classification
- Class III
- Status
- Ongoing
- Recall initiated
- Jul 27, 2023
- FDA report date
- Aug 23, 2023
- Quantity
- 82,400 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- ALEMBIC PHARMACEUTICALS, INC.
Original FDA data
Every field from FDA enforcement report D-1086-2023, exactly as published.
Show all FDA fields
- City
- Bedminster
- State
- NJ
- Status
- Ongoing
- Country
- United States
- Event ID
- 92811
- Address
- 550 Hills Dr Ste 104b
- Code information
- Lot #: AMR103, Exp: 10/2023; Lot#: AMR201, Exp: 06/2024
- Postal code
- 07921-1537
- Report date
- Aug 23, 2023
- Product type
- Drugs
- Recall number
- D-1086-2023
- Classification
- Class III
- Recalling firm
- ALEMBIC PHARMACEUTICALS, INC.
- Product quantity
- 82,400 bottles
- Reason for recall
- Failed Impurities/Degradation Specifications
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Tobramycin Opthalmic Solution USP, 0.3%, 5mL bottle, Rx only, Manufactured for: Alembic Pharmaceuticals, Bedminster, NJ 07921, USA, NDC 62332-518-05
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Jul 27, 2023
- Initial firm notification
- Letter
- Center classification date
- Aug 17, 2023