RecallRadar

FDA Drug recall D-0124-2017

Sodium Chloride Ophthalmic Solution, USP, 5%, 15 mL (0.5 fL oz.) bottle, Akorn, Inc., Lake Forest, IL 60045, NDC 17478-623-12

On 2016-11-09 the FDA classified a Class II recall of Sodium Chloride Ophthalmic Solution, USP, 5%, 15 mL (0.5 fL oz.) bottle, Akorn, Inc., Lake Forest, IL 60045, NDC 17478-623-12 by Akorn, citing subpotent Drug: concentration of product is less than labeled amount.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-0124-2017
ClassificationClass II
Statusterminated
Initiated2016-10-21
Published2016-11-09
Last updated2026-09-13 11:51 UTC
CompanyAkorn
DistributionUS

Product

Sodium Chloride Ophthalmic Solution, USP, 5%, 15 mL (0.5 fL oz.) bottle, Akorn, Inc., Lake Forest, IL 60045, NDC 17478-623-12.

Reason

Subpotent Drug: concentration of product is less than labeled amount.

Identifiers

code_infoLot: 041306A, Exp 04/19

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0124-2017%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.