The Recall Desk
SevereFDA (Drugs)·D-1326-2016·Announced 2016-07-20

Pharmakon Recalls Hydromorphone Syringes Due to Sterility Concerns

Pharmakon Pharmaceuticals is recalling 120 units of Hydromorphone HCI syringes due to a lack of assurance of sterility. The products were distributed nationwide and to specific VA/DOD facilities.

What this means for you

Illness, injury, or structural failure has been reported. 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 drug product, which poses a risk of serious infection or injury, meeting the criteria for a Severe rating.

Plain-English summary

Pharmakon Pharmaceuticals, Inc. is recalling 120 units of HYDROmorphone HCI 0.2 mg/mL in 0.9% Sodium Chloride 50 mL fill in a 60 mL Monoject Syringe. The recall was initiated due to a lack of assurance of sterility. The affected products are prescription-only and were compounded by Pharmakon Pharmaceuticals in Noblesville, Indiana.

The recall covers all sterile compounded products within their expiry date. The products were distributed nationwide, as well as to specific VA/DOD facilities in California, Kentucky, Maryland, North Carolina, Oklahoma, Texas, and Virginia.

Healthcare providers and patients should stop using the affected syringes and contact Pharmakon Pharmaceuticals for further instructions. The FDA has classified this recall as Class II, indicating that use of the product could cause temporary or medically reversible health consequences.

The recalled product

Product
HYDROmorphone HCI 0.2 mg/mL in 0.9% Sodium Chloride 50 mL fill in a 60 mL Monoject Syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0933-75
Manufacturer
Pharmakon Pharmaceuticals, Inc.
Category
Drug — Sterile Compounded Product
Hazard
Affected units
120

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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