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.
Product description
Phenylephrine Hydrochloride Ophthalmic Solution, USP, 2.5%, 15 mL bottle, Rx only, Mfd. by: Akorn, Inc., Lake Forest, IL 60045; NDC 17478-201-15.
Lot numbers, UPCs & expiration codes
Lot #: 031908A, Exp 03/20
Where it was sold
Nationwide in the USA and Puerto Rico
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-1883-2019
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Sep 20, 2019
- FDA report date
- Oct 9, 2019
- Quantity
- 60,176 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Akorn, Inc.
Original FDA data
Every field from FDA enforcement report D-1883-2019, exactly as published.
Show all FDA fields
- City
- Lake Forest
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 83843
- Address
- 1925 W Field Ct Ste 300
- Code information
- Lot #: 031908A, Exp 03/20
- Postal code
- 60045-4862
- Report date
- Oct 9, 2019
- Product type
- Drugs
- Recall number
- D-1883-2019
- Classification
- Class II
- Recalling firm
- Akorn, Inc.
- Product quantity
- 60,176 bottles
- Termination date
- Aug 1, 2022
- Reason for recall
- Lack of Assurance of Sterility: Out of specification results for container closure test which cannot guarantee the sterility of the product.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Phenylephrine Hydrochloride Ophthalmic Solution, USP, 2.5%, 15 mL bottle, Rx only, Mfd. by: Akorn, Inc., Lake Forest, IL 60045; NDC 17478-201-15.
- Distribution pattern
- Nationwide in the USA and Puerto Rico
- Recall initiation date
- Sep 20, 2019
- Initial firm notification
- Letter
- Center classification date
- Sep 30, 2019