Agency classClass IIOur severity:Severe FDA (Drugs)·D-1317-2016·Announced 2016-07-20

Pharmakon Recalls Morphine Sulfate IV Bags Due to Sterility Concerns

Pharmakon Pharmaceuticals is recalling 45 units of Morphine Sulfate IV bags due to a lack of assurance of sterility. The affected products were distributed nationwide and to specific VA/DOD facilities.

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 source text identifies the agency classification as Class II. According to the rubric, FDA Class II recalls involving significant injury or structural defects, or those not explicitly ruled out as low-risk, align with a Severe (4) rating, particularly given the critical nature of IV sterility.

Plain-English summary

Pharmakon Pharmaceuticals, Inc. is recalling 45 units of Morphine Sulfate (PF) 1mg/mL in 0.9% Sodium Chloride, 50 mL Intravia Bag IV USE ONLY. The recall was initiated because of a lack of assurance of sterility for the compounded sterile products.

The affected products are identified by NDC 45183-0877-41 and include all sterile compounded products within their expiry dates. The distribution pattern indicates the products were shipped nationwide, with specific distribution to VA/DOD facilities in California, Kentucky, Maryland, North Carolina, Oklahoma, Texas, and Virginia.

Healthcare providers and patients should stop using the affected Morphine Sulfate IV bags and contact Pharmakon Pharmaceuticals or their healthcare provider for further instructions. 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: Morphine Sulfate (PF) 1mg/mL in 0.9% Sodium Chloride, 50 mL lntravia Bag IV USE ONLY, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0877-41
Manufacturer: Pharmakon Pharmaceuticals, Inc.
Category: Drug — IV Infusion
Hazard: sterility
Affected units: 45

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 (1)

All Sterile Compounded Products within Expiry

Distribution

Distributed nationwide across the United States.

The notice also names 7 states specifically:

Part of a larger recall action

This product is one of 88 recalled by Pharmakon Pharmaceuticals, Inc. 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 88 products in this recall →

Same manufacturer · Pharmakon Pharmaceuticals, Inc.

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Same hazard · sterility