The Recall Desk
SevereFDA (Drugs)·D-0955-2020·Announced 2020-03-11

Axia Pharmaceutical Recalls Glycine Injection Due to Sterility Concerns

Fusion IV Pharmaceuticals is recalling specific lots of Glycine Injection because the company cannot guarantee the product's 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 and involves a lack of assurance of sterility in an injectable medication, which poses a risk of serious infection or adverse health consequences.

Plain-English summary

Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical is recalling specific lots of Glycine Injection, GLYCINE USP 50MG/ML INJECTABLE. The recall is being conducted due to a lack of assurance of sterility for the affected products.

The recalled product is a 30 mL multi-dose vial intended for intravenous (IV) and intramuscular (IM) use. It is available by prescription only. The specific lots affected are 07012019+52572 (expiration date 4/6/2020) and 10102019+53106 (expiration date 6/30/2020).

The products were distributed nationwide in the United States, as well as in Puerto Rico, Barbados, and the Dominican Republic. Healthcare providers and patients should check their inventory and discontinue use of the affected lots. The FDA has classified this recall as Class II, indicating that use of or exposure to the violative product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
Glycine Injection,GLYCINE USP 50MG/ML INJECTABLE, For IV, IM Use,30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0344-3
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 (4)

  • Lot #: 07012019+52572
  • Exp 4/6/2020
  • 10102019+53106
  • Exp 6/30/2020

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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