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

FDA recall notice · announced July 22, 2020 · Akorn

Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.

The product

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

Reason for recall

Chemical contamination; out of specification results obtained for equipment cleaning residue rinse sample

Notes

Distribution: Nationwide USA and Puerto Rico
Lot/code information: Lot 9E52A, exp 04/2021
Quantity: 33,343 bottles
Status: Terminated
Products in this recall event:
- 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 (D-1388-2020)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.