The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-0993-2016·Announced 2016-06-15

FDA Recalls Compounded L-Glutamine Injection Due to Sterility Concerns

Well Care Compounding Pharmacy is recalling compounded L-Glutamine/L-Arginine/L-Carnitine injections due to FDA inspection findings regarding sterility assurance.

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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II and involves a risk-of-harm product (sterility failure) where injury has not yet been reported, fitting the High severity criteria.

Plain-English summary

The U.S. Food and Drug Administration (FDA) has issued a recall for L-GLUT/L-ARG/L-CARN; 25MG/100MG/200MG/ML, packaged in 5mL vials. The product is a prescription-only compounded medication manufactured by Well Care Compounding Pharmacy in Las Vegas, Nevada. The recall involves 869 units distributed in Nevada.

The recall was initiated because an FDA inspection identified Good Manufacturing Practice (GMP) violations that potentially impact product quality and sterility. The specific hazard is a lack of assurance of sterility. The affected lots are identified as Lot # 01272016:54@25 with an expiration date of 02/27/2016, and Lot # 03292016: 62@36 with an expiration date of 04/29/2016.

Patients who have received this medication should contact their healthcare provider or pharmacist for guidance on next steps. The FDA classifies 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, or where the probability of serious adverse health consequences is remote.

The recalled product

Product
L-GLUT/L-ARG/L-CARN; 25MG/100MG/200MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
Manufacturer
Well Care Compounding Pharmacy
Category
Drug — Compounded Injectable
Hazard
Affected units
869

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 #: 01272016:54@25
  • Exp.02/27/2016
  • Lot #: 03292016: 62@36
  • Exp.04/29/2016

Distribution

Distributed in 1 state:

Part of a larger recall action

This product is one of 51 recalled by Well Care Compounding Pharmacy 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 51 products in this recall →

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