FDA Drug recall D-1388-2020
Proparacaine Hydrochloride Ophthalmic Solution, USP, 0.5%, 15 mL per dropper bottle, Sterile, Rx Only, Manufactured by: Akorn, Inc., Lake F…
- FDA Drug
- Class III
- terminated
- Published 2020-07-22
On 2020-07-22 the FDA classified a Class III recall of Proparacaine Hydrochloride Ophthalmic Solution, USP, 0.5%, 15 mL per dropper bottle, Sterile, Rx Only, Manufactured by: Akorn, Inc., Lake F… by Akorn, citing chemical contamination; out of specification results obtained for equipment cleaning residue rinse sample.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1388-2020 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2019-12-26 |
| Published | 2020-07-22 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Akorn |
| Distribution | US |
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
Chemical contamination; out of specification results obtained for equipment cleaning residue rinse sample
Identifiers
| code_info | Lot 9E52A, exp 04/2021 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1388-2020%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.