The Recall Desk
SevereFDA (Drugs)·D-0956-2020·Announced 2020-03-11

Axia Pharmaceutical Recalls hCG Injection Due to Sterility Concerns

Axia Pharmaceutical is recalling specific lots of Human Chorionic Gonadotropin (hCG) Injection due to a lack of assurance of sterility.

What this means for you

Illness, injury, or structural failure has been reported. 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, an FDA Class II recall involving a significant hazard such as lack of sterility in an injectable drug warrants a 'Severe' rating (Score 4), as it may cause temporary or medically reversible adverse health consequences.

Plain-English summary

Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical is recalling specific lots of Human Chorionic Gonadotropin (hCG) Injection, 1000 IU/mL, 10 mL multi-dose vials. The recall is being conducted because of a lack of assurance of sterility in the product.

The affected product is distributed nationwide in the U.S.A., as well as in Puerto Rico, Barbados, and the Dominican Republic. The recall includes four specific lot numbers with expiration dates ranging from January 2020 to May 2020.

Consumers and healthcare providers should stop using the affected lots and contact their healthcare provider or the recalling firm for further instructions. The FDA has classified this recall as Class II, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
Human Chorionic Gonadotropin (hCG) Injection, HCG [10ML] 1000 IU/ML INJECTABLE, For IM, SC Use, Refrigerate,10 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0533-1
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 (8)

  • Lot #: 07222019+52720
  • Exp 1/28/2020
  • 09182019+52923
  • Exp 3/26/2020
  • 10232019+53148
  • Exp 2/28/2020
  • 11142019+53243
  • Exp 5/22/2020

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 →

Related recalls

Same manufacturer · Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical

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Same hazard · sterility

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