The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1343-2016·Announced 2016-07-20

Pharmakon Recalls Bupivacaine Bags Due to Sterility Concerns

Pharmakon Pharmaceuticals is recalling 70 units of Bupivacaine HCI 0.25% bags because the company cannot assure the products are sterile.

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. According to the rubric, FDA Class II recalls with potential for adverse health consequences (such as lack of sterility in injectable drugs) are categorized as Severe (Score 4), particularly when structural or process defects like sterility assurance are involved.

Plain-English summary

Pharmakon Pharmaceuticals, Inc. is recalling 70 units of Bupivacaine HCI 0.25% in 0.9% Sodium Chloride, 500 mL Intravia bags. The recall is being conducted because the company lacks assurance of the sterility of these compounded products.

The affected products are identified by NDC 45183-0994-03 and include all sterile compounded products within their expiry dates. The distribution pattern indicates the products were shipped nationwide, with specific mentions of distribution to VA/DOD facilities in California, Kentucky, Maryland, North Carolina, Oklahoma, Texas, and Virginia.

Consumers and healthcare providers should stop using the recalled products and contact Pharmakon Pharmaceuticals or their healthcare provider for further instructions. The recall is classified as FDA Class II, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
Bupivacaine HCI 0.25% in 0.9% Sodium Chloride, 500 mL Intravia bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0994-03
Manufacturer
Pharmakon Pharmaceuticals, Inc.
Category
Drug — Injectable
Hazard
Affected units
70

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 →

Related recalls

Same manufacturer · Pharmakon Pharmaceuticals, Inc.

See all →

Same hazard · lack of sterility

See all →

Similar recalls