Skip to content
Recall Observatory FDA recall evidence

Drug product

oxyTOCIN 20 units added to Lactated Ringer's 1000 mL, IV Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-6038-1

D-0984-2023

July 14, 2023

Class II

Product summary

Firm
Central Admixture Pharmacy Services, Inc.
Event
Event 92707
Status
Terminated
Classification
Class II
Quantity
9504 bags
Official record key
drug-enforcement:D-0984-2023

Official wording

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

Code information: Lot: 36-247256, 36-247525, 36-247259, Exp. 7/14/2023; 36-247782, 36-247784, Exp. 7/15/2023; 36-247980, Exp. 7/16/2023; 36-248274, 36-248275, Exp. 7/19/2023; 36-248732, 36-248733, 36-248734, 36-248735, Exp. 7/21/2023; 36-248971, 36-248990, Exp. 7/22/2023; 36-249510, 36-249511, 36-249512, Exp. 7/24/2023; 36-249722, 36-249723, Exp. 7/26/2023; 36-251196, 36-251198, Exp. 7/30/2023; 36-251431, 36-251432, 36-251433, Exp. 8/3/2023; 36-251985, 36-251986, 36-251987, 36-251989, Exp. 8/5/2023; 36-256901, 36-256902, 36-256903, 36-256904, 36-256906, Exp. 8/20/2023

Distribution pattern: Nationwide in the USA

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of assurance of sterility