The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1262-2016·Announced 2016-07-20

Pharmakon Recalls Hydromorphone Injection Due to Sterility Concerns

Pharmakon Pharmaceuticals is recalling 12 units of Hydromorphone HCl injection due to a lack of assurance of sterility. The product was 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 FDA classified this recall as Class II. According to the rubric, an FDA Class II recall involving a sterile product where sterility assurance is lacking is categorized as Severe (Score 4), as it poses a risk of serious injury or infection, even if specific hospitalization reports are not detailed in the provided text.

Plain-English summary

Pharmakon Pharmaceuticals, Inc. is recalling 12 units of Hydromorphone HCl 1mg/ml injection in 0.9% Sodium Chloride, 100 mL Cadd Cassette (grey). The recall is being conducted because of a lack of assurance of sterility for the compounded product. The affected product is identified by NDC 45183-0114-48 and includes all sterile compounded products within their expiry dates.

The recalled product was distributed nationwide as well as to specific VA/DOD facilities in California, Kentucky, Maryland, North Carolina, Oklahoma, Texas, and Virginia. 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.

Healthcare providers and patients should stop using the affected product and contact Pharmakon Pharmaceuticals for further instructions or a replacement. Consumers should not use the product if they have questions about its sterility or safety.

The recalled product

Product
Hydromorphone HCl 1mg/ml injection in 0.9% Sodium Chloride, 100 mL Cadd Cassette (grey), Rx Only,Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0114-48
Manufacturer
Pharmakon Pharmaceuticals, Inc.
Category
Drug — Injectable
Hazard
Affected units
12

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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