Recalls / Class II

Class IID-0984-2023

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

Affected lot / code info

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

Why it was recalled

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

Recalling firm

Firm

Central Admixture Pharmacy Services, Inc.

Notification channel

Letter

Type

Voluntary: Firm initiated

Address

2200 S 43rd Ave, N/A, Phoenix, Arizona 85043-3909

Distribution

Quantity

9504 bags

Distribution pattern

Nationwide in the USA

Timeline

Recall initiated

2023-07-14

FDA classified

2023-08-01

Posted by FDA

2023-08-09

Terminated

2025-03-28

Status

Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-0984-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.