D-0050-2017 Class II Terminated

Recalled by Pharmedium Services, LLC — Lake Forest, IL

FDA drug recall D-0050-2017 was initiated by Pharmedium Services, LLC on Jul 17, 2015 and is designated Class II. Reason for recall: Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes. The recall status is terminated (terminated Jun 23, 2017). Affected quantity: 1916 syringes.

Recall Details

Product Type
Drugs
Report Date
Oct 19, 2016
Initiation Date
Jul 17, 2015
Termination Date
Jun 23, 2017
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1916 syringes

Product Description

HYDROmorphone HCl, 0.2 mg per mL, (0.4 mg per 2 mL), in 0.9% Sodium Chloride, 2 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3162.

Reason for Recall

Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.

Distribution Pattern

Nationwide

Code Information

Lot Numbers: 151200003M, 151260128M, 151300005M, 151310094M, 151320134M, 151320143M, 151340107M, 151370002M, 151390005M, 151390142M, 151400005M, 151400095M, 151400136M, 151470008M, 151510002M, 151520080M, 151880214M, 151890257M, Exp between 07/15/15-10/12/15

Source

Dataset
openFDA drug recall enforcement reports
FDA record
This recall in openFDA (JSON)
Enforcement Report
Search FDA's Enforcement Report for D-0050-2017
openFDA file date
Oct 27, 2026
Loaded by RegDataLab
Oct 29, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.