Drug product
oxyTOCIN 15 Units added to 250 mL 5% Dextrose Injection USP, packaged in 250 mL bags, Rx only, PharMEDium Services, LLC, 12620 W Airport Blvd #130, Sugar Land, TX 77478, Service Code 2K2677, NDC# 61553-777-02.
D-1353-2015
Product summary
- Event
- Event 71846
- Status
- Terminated
- Classification
- Class I
- Quantity
- 72 bags
- Official record key
drug-enforcement:D-1353-2015
Official wording
Reason: 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.
Code information: Lot #: 15041113S, Exp 04/23/15
Distribution pattern: Nationwide
Derived failure modes
-
Foreign material or chemical contamination
Particulate Matter