The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1257-2016·Announced 2016-07-20

Pharmakon Recalls Bupivacaine Injection Bags Due to Sterility Concerns

Pharmakon Pharmaceuticals is recalling 130 bags of Bupivacaine 1mg/mL 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 recall is classified as FDA Class II, and the hazard involves a lack of assurance of sterility in an injectable drug, which poses a significant risk of serious injury or infection.

Plain-English summary

Pharmakon Pharmaceuticals, Inc. is recalling 130 bags of Bupivacaine 1mg/mL injection in 0.9% Sodium Chloride 250 mL bag (NDC 45183-0019-02). The recall was initiated because of a lack of assurance of sterility for the compounded sterile product.

The affected product was distributed nationwide and to VA/DOD facilities in California, Kentucky, Maryland, North Carolina, Oklahoma, Texas, and Virginia. The recall covers all sterile compounded products within their expiry dates.

Healthcare providers and patients should stop using the recalled product and contact Pharmakon Pharmaceuticals or their local FDA office for further instructions. Consumers should not use the product if they have it in their possession.

The recalled product

Product
Bupivacaine 1mg/mL injection in 0.9% Sodium Chloride 250 mL bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0019-02
Manufacturer
Pharmakon Pharmaceuticals, Inc.
Category
Drug — Injectable
Hazard
Affected units
130

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 · sterility

See all →

Similar recalls