Agency classClass IIOur severity:Severe FDA (Drugs)·D-1312-2016·Announced 2016-07-20

Pharmakon Recalls Hydromorphone IV Bags Due to Sterility Concerns

Pharmakon Pharmaceuticals is recalling 675 units of compounded Hydromorphone HCI IV bags 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 recall is classified as FDA Class II and involves a lack of assurance of sterility in an intravenous product, which poses a significant risk of serious injury or death if contaminated.

Plain-English summary

Pharmakon Pharmaceuticals, Inc. is recalling 675 units of Hydromorphone HCI 1 mg/mL in 0.9% Sodium Chloride, 50 mL Intravia bags. The product is compounded and intended for intravenous use only. The recall was initiated because of a lack of assurance of sterility.

The affected product is identified by NDC 45183-0865-41. The recall covers all sterile compounded products within their expiry dates. The distribution pattern is listed as nationwide, with specific mentions of VA/DOD locations in California, Kentucky, Maryland, North Carolina, Oklahoma, Texas, and Virginia.

Consumers and healthcare providers should stop using the recalled product and contact Pharmakon Pharmaceuticals or their healthcare provider for further instructions. This recall is classified as Class II by the FDA.

The recalled product

Product: Hydromorphone HCI 1 mg/mL in 0.9% Sodium Chloride, 50 mL lntravia bag IV USE ONLY, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060 , NDC 45183-0865-41
Manufacturer: Pharmakon Pharmaceuticals, Inc.
Category: Drug — Compounded IV
Hazard: sterility
infection
Affected units: 675

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.

See all →

Severe
Pharmakon Recalls Fentanyl and Ropivacaine Bags Due to Sterility Concerns
FDA (Drugs) · 2016-07-20
Severe
Pharmakon Recalls Phenylephrine Syringes Due to Sterility Concerns
FDA (Drugs) · 2016-07-20
Severe
Pharmakon Recalls Methohexital Syringes Due to Sterility Concerns
FDA (Drugs) · 2016-07-20
Severe
Pharmakon Recalls Fentanyl Citrate Syringes Due to Sterility Concerns
FDA (Drugs) · 2016-07-20
Severe
Pharmakon Recalls Ketamine Bags Due to Sterility Concerns
FDA (Drugs) · 2016-07-20

Same hazard · sterility