Recalls / Class III
Class IIID-1471-2022
Product
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
- Affected lot / code info
- Lot #: 9N72, EXP 09/30/2022
Why it was recalled
Failed Impurities/Degradation Specifications: Identification of an unknown impurity at the 12-month stability point.
Recalling firm
- Firm
- Akorn, Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 5605 Centerpoint Ct Ste B, Gurnee, Illinois 60031-5278
Distribution
- Quantity
- 5,226 Cartons (60 vials/carton)
- Distribution pattern
- Distributed Nationwide in the USA
Timeline
- Recall initiated
- 2022-08-08
- FDA classified
- 2022-08-29
- Posted by FDA
- 2022-09-07
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-1471-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.