Recalls / Class II
Class IID-1883-2019
Product
Phenylephrine Hydrochloride Ophthalmic Solution, USP, 2.5%, 15 mL bottle, Rx only, Mfd. by: Akorn, Inc., Lake Forest, IL 60045; NDC 17478-201-15.
- Affected lot / code info
- Lot #: 031908A, Exp 03/20
Why it was recalled
Lack of Assurance of Sterility: Out of specification results for container closure test which cannot guarantee the sterility of the product.
Recalling firm
- Firm
- Akorn, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1925 W Field Ct Ste 300, N/A, Lake Forest, Illinois 60045-4862
Distribution
- Quantity
- 60,176 bottles
- Distribution pattern
- Nationwide in the USA and Puerto Rico
Timeline
- Recall initiated
- 2019-09-20
- FDA classified
- 2019-09-30
- Posted by FDA
- 2019-10-09
- Terminated
- 2022-08-01
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1883-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.