The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-1364-2016·Announced 2016-07-27

PharMEDium Recalls Bupivacaine HCl Injectable Bags Due to Glass Particulate

PharMEDium Services is recalling 4,081 bags of 0.1% Bupivacaine HCl injectable solution 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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a sterile injectable drug contaminated with glass particulate matter, which poses a risk of harm (injury) to patients, but the source text does not report any actual injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

PharMEDium Services, LLC is recalling 4,081 bags of 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride. The recall involves multiple container sizes and types, including Baxter Intravia Bags, Hospira LifeCare Bags, and Smiths Medical Cassettes, 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 affected lots have expiration dates ranging from May 2016 to July 2016.

Healthcare facilities and patients who have received these specific lots of Bupivacaine HCl should contact their healthcare provider or the recalling firm for further instructions. The source text does not report any illnesses or injuries associated with this recall.

The recalled product

Product
0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, Service Code 2K8195, 100 ml in 150 ml Baxter Intravia Bag (NDC 61553-195-48), Service Code 2H8266, 250 ml in 250 ml Hospira LifeCare Bag NDC 61553-266-50), 100 ml in 100 ml Hospira LifeCare Bag, Service Code…
Manufacturer
Pharmedium Services, LLC
Category
Drug — Injectable
Hazard
Affected units
4,081

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 2K8195
  • Lot Number 160390084M
  • Exp. Date 5/9/2016
  • Lot Number 160530298M
  • Exp. Date 5/23/2016
  • Lot Number 160540203M
  • Exp. Date 5/24/2016
  • Lot Number 160550182M
  • Exp. Date 5/25/2016
  • Lot Number 160590153M
  • Exp. Date 5/29/2016
  • Lot Number 160660150M
  • Exp. Date 6/5/2016
  • Lot Number 160740115M
  • Exp. Date 6/12/2016
  • Lot Number 160810295M
  • Exp. Date 6/20/2016
  • Lot Number 160820217M
  • Exp. Date 6/21/2016
  • Lot Number 160830164M

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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