D-0044-2017 Class II Terminated

Recalled by Pharmedium Services, LLC — Lake Forest, IL

FDA drug recall D-0044-2017 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: 16366 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
16366 syringes

Product Description

glycopyrrolate, 0.2 mg per mL, 0.6 mg per 3 mL, 3 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3217.

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: 15100141M, 15118066M, 15118083M, 15121090M, 15124001M, 15126042M, 15127036M, 15128030M, 15132065M, 15133010M, 15134007M, 15135010M, 15138062M, 15139002M, 15139003M, 15139052M, 15139053M, 15140083M, 15142002M, 15142090M, 15146084M, 15148044M, 15150014M, 15153002M, 151720016M, 151740133M, 151880151M, 151890120M, 151890239M, 151900019M, 151910015M, 151930042M, 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-0044-2017
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.