Why it was recalled
Chemical contamination; out of specification results obtained for equipment cleaning residue rinse sample
Product description
Proparacaine Hydrochloride Ophthalmic Solution, USP, 0.5%, 15 mL per dropper bottle, Sterile, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC 17478-263-12
Lot numbers, UPCs & expiration codes
Lot 9E52A, exp 04/2021
Where it was sold
Nationwide 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-1388-2020
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Dec 26, 2019
- FDA report date
- Jul 22, 2020
- Quantity
- 33,343 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Akorn, Inc.
Original FDA data
Every field from FDA enforcement report D-1388-2020, exactly as published.
Show all FDA fields
- City
- Lake Forest
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 86019
- Address
- 1925 W Field Ct Ste 300
- Code information
- Lot 9E52A, exp 04/2021
- Postal code
- 60045-4862
- Report date
- Jul 22, 2020
- Product type
- Drugs
- Recall number
- D-1388-2020
- Classification
- Class III
- Recalling firm
- Akorn, Inc.
- Product quantity
- 33,343 bottles
- Termination date
- Jul 28, 2022
- Reason for recall
- Chemical contamination; out of specification results obtained for equipment cleaning residue rinse sample
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Proparacaine Hydrochloride Ophthalmic Solution, USP, 0.5%, 15 mL per dropper bottle, Sterile, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC 17478-263-12
- Distribution pattern
- Nationwide USA and Puerto Rico
- Recall initiation date
- Dec 26, 2019
- Initial firm notification
- Letter
- Center classification date
- Jul 14, 2020