The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0958-2020·Announced 2020-03-11

Axia Pharmaceutical Recalls Hydroxyprogesterone Caproate Injection Due to Sterility Concerns

Axia Pharmaceutical is recalling Hydroxyprogesterone Caproate Injection because the product lacks assurance of sterility. The recall covers specific lots distributed nationwide and in Puerto Rico, Barbados, and the Dominican Republic.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II. According to the rubric, FDA Class II recalls involving significant injury or property damage reports, or structural defects, are rated as Severe. While no injuries are reported, the lack of sterility assurance in an injectable drug represents a significant potential hazard.

Plain-English summary

Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical is recalling Hydroxyprogesterone Caproate Injection, 250 mg/mL, 4 mL multi-dose vials. The recall is being conducted because the product lacks assurance of sterility. The affected product is identified by NDC 71283-0532-5, Lot # 07302019+52772, with an expiration date of 2/25/2020.

The recalled product was distributed nationwide in the United States, as well as in Puerto Rico, Barbados, and the Dominican Republic. The source text does not specify the number of units recalled or report any illnesses or injuries associated with the use of this product.

Healthcare providers and patients should stop using the affected product and contact the manufacturer or their local FDA office for further instructions. Consumers should not use the product if they have questions about its sterility or safety.

The recalled product

Product
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
Manufacturer
Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical
Category
Drug — Injectable
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Lot #: 07302019+52772
  • Exp 2/25/2020

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 63 recalled by Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 63 products in this recall →

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