FDA Recall D-1471-2022
Akorn, Inc · Gurnee, IL
Class III Ongoing 1375 days on record
Lower impact — Class III recall — product violates FDA labeling or manufacturing standards but is unlikely to cause adverse health consequences.
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
Reason for recall
Failed Impurities/Degradation Specifications: Identification of an unknown impurity at the 12-month stability point.
Recall record
- Recall number
D-1471-2022- Classification
- Class III
- Status
- Ongoing
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- Distributed Nationwide in the USA
- Recall initiated
- 2022-08-08
- Classified by FDA Center
- 2022-08-29
- FDA published
- 2022-09-07
- Recalling firm
- Akorn, Inc
- Firm location
- Gurnee, IL
Operational response
Class III recalls are unlikely to cause adverse health consequences but indicate a violation of FDA labeling or manufacturing standards. Pull from active dispensing per your operational policy.
For the official FDA enforcement record, see FDA's Recall Search.