The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1365-2016·Announced 2016-07-27

Pharmedium Recalls Bupivacaine HCl Bags Due to Glass Particulate Matter

Pharmedium Services, LLC is recalling 8,581 bags of 0.125% Bupivacaine HCl because the active ingredient was contaminated with glass particulate matter.

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 as a Class II recall involving a sterile injectable drug contaminated with glass particulate matter, which poses a significant risk of injury if administered.

Plain-English summary

Pharmedium Services, LLC is recalling 8,581 bags of 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride. The recall involves various bag sizes and service codes, including Hospira LifeCare, Cormix, and Baxter Intravia bags. The product is compounded in Memphis, TN, and distributed nationwide.

The recall was initiated because the active pharmaceutical ingredient (API) used to produce these sterile injectable drugs was contaminated with glass particulate matter. The FDA has classified this recall as Class II, indicating a reasonable probability that use of the product could cause temporary or medically reversible adverse health consequences.

Hospitals and healthcare facilities that have received these products should stop using the affected lots immediately. Patients who have received these injections should contact their healthcare provider if they experience any adverse effects. The specific lot numbers and expiration dates are listed in the official FDA recall notice D-1365-2016.

The recalled product

Product
0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 100 mL Hospira LifeCare Bag Service Code 2H8194 (NDC 61553-194-52 ), 250 mL in 250 mL Cormix Bag ,Service Code 2C8192 (NDC 61553-192-17), 400 mL in 500 mL Baxter Intravia Bag, Service Code 2K8169 (NDC…
Manufacturer
Pharmedium Services, LLC
Category
Drug — Injectable
Hazard
Affected units
8,581

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 (20)

  • Service Code 2C8192
  • Lot Number 160830033M
  • Exp. Date 5/7/2016
  • Service Code 2H8192
  • Lot Number 160380144M
  • Exp. Date 5/8/2016
  • Lot Number 160480178M
  • Exp. Date 5/18/2016
  • Lot Number 160610225M
  • Exp. Date 5/31/2016
  • Lot Number 160690186M
  • Exp. Date 6/8/2016
  • Lot Number 160730071M
  • Exp. Date 6/12/2016
  • Lot Number 160760041M
  • Exp. Date 6/14/2016
  • Lot Number 160820212M
  • Exp. Date 6/21/2016
  • Lot Number 160880171M
  • Exp. Date 6/27/2016

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 75 recalled by Pharmedium Services, LLC 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 75 products in this recall →

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