The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1338-2016·Announced 2016-07-20

Pharmakon Recalls Midazolam HCI Syringes Due to Sterility Concerns

Pharmakon Pharmaceuticals is recalling 2,000 units of compounded Midazolam HCI syringes due to a lack of assurance of sterility.

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. Per the rubric, an FDA Class II recall involving a sterile product defect (lack of assurance of sterility) is classified as Severe (Score 4) due to the risk of significant injury or infection, even without explicit reports of hospitalization in the provided text.

Plain-English summary

Pharmakon Pharmaceuticals, Inc. is recalling 2,000 units of Midazolam HCI 1mg/mL in 0.9% Sodium Chloride, 2 mL fill in a 3 mL syringe. The recall was initiated due to a lack of assurance of sterility for the sterile compounded products.

The affected products are identified by NDC 45183-0966-69 and were compounded by Pharmakon Pharmaceuticals in Noblesville, Indiana. The distribution pattern is listed as nationwide, with specific mentions of VA/DOD locations in California, Kentucky, Maryland, North Carolina, Oklahoma, Texas, and Virginia. The recall covers all sterile compounded products within their expiry dates.

Consumers and healthcare providers should stop using the recalled syringes and contact their pharmacist or the recalling firm 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
Midazolam HCI 1mg/mL in 0.9% Sodium Chloride ,2 mL fill in a 3 mL syringe; Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0966-69
Manufacturer
Pharmakon Pharmaceuticals, Inc.
Category
Drug — Compounded Sterile Product
Hazard
Affected units
2,000

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 →

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