Agency classClass IIOur severity:Severe FDA (Drugs)·D-1307-2016·Announced 2016-07-20

Pharmakon Recalls Morphine Sulfate Syringes Due to Sterility Concerns

Pharmakon Pharmaceuticals is recalling Morphine Sulfate syringes because the company cannot guarantee the products are sterile.

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 and involves a lack of assurance of sterility in a sterile compounded product, which poses a significant risk of infection or serious injury.

Plain-English summary

Pharmakon Pharmaceuticals, Inc. is recalling 30 units of Morphine Sulfate (Preserved) 2mg/mL in 0.9% Sodium Chloride 50 mL fill in a 60 ml BD Syringe. The recall is being conducted because the company lacks assurance of the sterility of the affected products. The products are prescription-only and were compounded by Pharmakon Pharmaceuticals in Noblesville, Indiana.

The affected products were distributed nationwide, including to VA and DOD facilities in California, Kentucky, Maryland, North Carolina, Oklahoma, Texas, and Virginia. The recall covers all sterile compounded products within their expiry dates. The FDA has classified this recall as Class II.

Consumers and healthcare providers should stop using the affected syringes and contact their pharmacist or healthcare provider for further instructions. The recall is voluntary and is being conducted to ensure patient safety.

The recalled product

Product: Morphine Sulfate (Preserved) 2mg/mL in 0.9% Sodium Chloride 50 mL fill in a 60 ml BD Syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0823-75
Manufacturer: Pharmakon Pharmaceuticals, Inc.
Category: Drug — Sterile Compounded Product
Hazard: sterility
infection
Affected units: 30

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