The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1341-2016·Announced 2016-07-20

Pharmakon Recalls Midazolam HCl Bags Due to Sterility Concerns

Pharmakon Pharmaceuticals is recalling 10 bags of Midazolam HCl 1mg/mL due to a lack of assurance of sterility. The 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 recall is classified as FDA Class II and involves a lack of assurance of sterility in a compounded drug, which poses a risk of serious health consequences such as infection.

Plain-English summary

Pharmakon Pharmaceuticals, Inc. is recalling 10 bags of Midazolam HCl 1mg/mL in 0.9% Sodium Chloride, 50 mL Intravia bag, Rx Only. The recall is being conducted due to a lack of assurance of sterility. The affected products are identified by NDC 45183-0989-41 and include all sterile compounded products within their expiry dates.

The recalled products were distributed nationwide as well as to VA/DOD facilities in California, Kentucky, Maryland, North Carolina, Oklahoma, Texas, and Virginia. The recall is classified as Class II by the FDA.

Healthcare providers and patients should stop using the recalled products and contact Pharmakon Pharmaceuticals or their healthcare provider for further instructions. Consumers should not use these products if they have them in their possession.

The recalled product

Product
Midazolam HCl 1mg/mL in 0.9% Sodium Chloride, 50 mL Intravia bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0989-41
Manufacturer
Pharmakon Pharmaceuticals, Inc.
Category
Drug — Compounded Injectable
Hazard
Affected units
10

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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