D-1356-2015 Class I Terminated
FDA drug recall D-1356-2015 was initiated by Pharmedium Services, LLC on Apr 13, 2015 and is designated Class I. Reason for recall: Presence of Particulate Matter: The firm produced products using 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP which were subsequently recalled by the manufacturer due to the… The recall status is terminated (terminated Jan 23, 2017). Affected quantity: 48 bags.
Recall Details
- Product Type
- Drugs
- Report Date
- Sep 2, 2015
- Initiation Date
- Apr 13, 2015
- Termination Date
- Jan 23, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 48 bags
Product Description
EPINEPHrine HCl 16 mg added to 250 mL 0.9% Sodium Chloride Injection USP (64 mcg per mL), packaged in 250 mL bags, Rx only, PharMEDium Services, LLC, 12620 W. Airport Blvd #130, Sugar Land, TX 77478, Service Code 2K6618, NDC# 61553-618-61.
Reason for Recall
Presence of Particulate Matter: The firm produced products using 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP which were subsequently recalled by the manufacturer due to the presence of particulate matter.
Distribution Pattern
Nationwide
Code Information
Lot #: 15033060S, Exp 05/03/15
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1356-2015
- openFDA file date
- Oct 27, 2026
- Loaded by RegDataLab
- Oct 29, 2026