Hydromorphone HCl 0.5 mg per mL in 0.9% Sodium Chloride Injection 1 mL, packaged in syringes, Rx ...
FDA Recall #D-0080-2018 — Class II — October 13, 2017
Product Description
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 for Recall
Superpotent drug: out of specification result for potency
Recalling Firm
PharMEDium Services, LLC. — Memphis, TN
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
499 syringes
Distribution
CA, IL
Code Information
Lot#: 172820134M, Exp 01/18
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated