RecallRadar

FDA Drug recall D-0080-2018

Hydromorphone HCl 0.5 mg per mL in 0.9% Sodium Chloride Injection 1 mL, packaged in syringes, Rx Only , PharMEDium Services, LLC. 913 N. Da…

On 2017-11-22 the FDA classified a Class II recall of Hydromorphone HCl 0.5 mg per mL in 0.9% Sodium Chloride Injection 1 mL, packaged in syringes, Rx Only , PharMEDium Services, LLC. 913 N. Da… by Pharmedium Services, citing superpotent drug: out of specification result for potency.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-0080-2018
ClassificationClass II
Statusterminated
Initiated2017-10-13
Published2017-11-22
Last updated2026-09-13 11:51 UTC
CompanyPharmedium Services
DistributionCA, IL

Product

Hydromorphone HCl 0.5 mg per mL in 0.9% Sodium Chloride Injection 1 mL, packaged in syringes, Rx Only , PharMEDium Services, LLC. 913 N. Davis Ave Cleveland, MS 38732, NDC 61553-352-40

Reason

Superpotent drug: out of specification result for potency

Identifiers

code_infoLot#: 172820134M, Exp 01/18

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-0080-2018%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.