PlainRecalls
FDA Drug Moderate Class II Terminated

Hydroxyprogesterone Caproate Injection, HYDROXYPROGESTERONE CAPROATE [4ML] 250 MG/ML INJECTABLE, For IV, IM Use, Refrigerate, 4 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0532-5

Reported: March 11, 2020 Initiated: January 15, 2020 #D-0958-2020

Product Description

Hydroxyprogesterone Caproate Injection, HYDROXYPROGESTERONE CAPROATE [4ML] 250 MG/ML INJECTABLE, For IV, IM Use, Refrigerate, 4 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0532-5

Reason for Recall

Lack of Assurance of Sterility

Details

Units Affected
N/A
Distribution
U.S.A. Nationwide and Puerto Rico, Barbados and Dominican Republic
Location
Los Angeles, CA

Frequently Asked Questions

What product was recalled?
Hydroxyprogesterone Caproate Injection, HYDROXYPROGESTERONE CAPROATE [4ML] 250 MG/ML INJECTABLE, For IV, IM Use, Refrigerate, 4 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0532-5. Recalled by Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical. Units affected: N/A.
Why was this product recalled?
Lack of Assurance of Sterility
Which agency issued this recall?
This recall was issued by the FDA Drug on March 11, 2020. Severity: Moderate. Recall number: D-0958-2020.