Why it was recalled
Failed Impurities/Degradation Specifications: Identification of an unknown impurity at the 12-month stability point.
Product description
Timolol Maleate Ophthalmic Solution, USP, 0.5%, 5 x 0.3 mL Single-Dose Vials, Rx Only, Sterile, Manufactured for: Akorn, Inc., Lake Forest, IL 60045. NDC 17478-189-24
Lot numbers, UPCs & expiration codes
Lot #: 9N72, EXP 09/30/2022
Where it was sold
Distributed 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-1471-2022
- Classification
- Class III
- Status
- Ongoing
- Recall initiated
- Aug 8, 2022
- FDA report date
- Sep 7, 2022
- Quantity
- 5,226 Cartons (60 vials/carton)
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Akorn, Inc
Original FDA data
Every field from FDA enforcement report D-1471-2022, exactly as published.
Show all FDA fields
- City
- Gurnee
- State
- IL
- Status
- Ongoing
- Country
- United States
- Event ID
- 90720
- Address
- 5605 Centerpoint Ct Ste B
- Code information
- Lot #: 9N72, EXP 09/30/2022
- Postal code
- 60031-5278
- Report date
- Sep 7, 2022
- Product type
- Drugs
- Recall number
- D-1471-2022
- Classification
- Class III
- Recalling firm
- Akorn, Inc
- Product quantity
- 5,226 Cartons (60 vials/carton)
- Reason for recall
- Failed Impurities/Degradation Specifications: Identification of an unknown impurity at the 12-month stability point.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Timolol Maleate Ophthalmic Solution, USP, 0.5%, 5 x 0.3 mL Single-Dose Vials, Rx Only, Sterile, Manufactured for: Akorn, Inc., Lake Forest, IL 60045. NDC 17478-189-24
- Distribution pattern
- Distributed Nationwide in the USA
- Recall initiation date
- Aug 8, 2022
- Initial firm notification
- Letter
- Center classification date
- Aug 29, 2022