FDA-Drug2023-08-09Class II

oxyTOCIN, 20 units added to dextrose 5%/lactated ringers 1000 mL, IV Bag, Rx Only, This drug was repacked by CAPS, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-6031-1

Hazard

Lack of assurance of sterility. Validation data for decontamination cycles is lacking.

Sold states
Nationwide in the USA
Affected count
463 bags
Manufactured in
2200 S 43rd Ave, N/A, Phoenix, AZ, United States
Products
oxyTOCIN, 20 units added to dextrose 5%/lactated ringers 1000 mL, IV Bag, Rx Only, This drug was repacked by CAPS, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-6031-1

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0983-2023

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