RecallRadar

FDA Drug recall D-0589-2016

Epinephrine (PF) 10 mcg/mL in 0.9% Sodium Chloride, injectable packed in syringes, Total dosage 50 mg/ 5mL, Rx only, PHARMAKON Pharmaceutic…

On 2016-02-03 the FDA classified a Class II recall of Epinephrine (PF) 10 mcg/mL in 0.9% Sodium Chloride, injectable packed in syringes, Total dosage 50 mg/ 5mL, Rx only, PHARMAKON Pharmaceutic… by Pharmakon Pharmaceuticals, citing subpotent drug.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-0589-2016
ClassificationClass II
Statusterminated
Initiated2015-08-19
Published2016-02-03
Last updated2026-09-13 11:51 UTC
CompanyPharmakon Pharmaceuticals
DistributionUS

Product

Epinephrine (PF) 10 mcg/mL in 0.9% Sodium Chloride, injectable packed in syringes, Total dosage 50 mg/ 5mL, Rx only, PHARMAKON Pharmaceuticals, Inc.

Reason

Subpotent drug.

Identifiers

code_infoAll lots with expiration dates up to 11/17/2015

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-0589-2016%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.