FDAFDA · Food and drugs·Recall number D-1388-2020
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
Published July 22, 2020 · Recall initiated: December 26, 2019
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Chemical contamination; out of specification results obtained for equipment cleaning residue rinse sample
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Akorn, Inc.
- Distributor
- Nationwide USA and Puerto Rico
- Lot
- Lot 9E52A, exp 04/2021
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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