The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1362-2016·Announced 2016-07-27

PharMEDium Recalls Bupivacaine HCl Due to Glass Particulate Contamination

PharMEDium Services, LLC is recalling 2,194 bags and cassettes of 0.0625% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride because the active pharmaceutical 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 recall is classified as FDA Class II, and the presence of glass particulate matter in sterile injectable drugs poses a significant risk of injury, meeting the criteria for a Severe rating.

Plain-English summary

PharMEDium Services, LLC is recalling 2,194 bags and cassettes of 0.0625% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride. The recall involves multiple container types, including Hospira LifeCare Bags, Baxter Intravia Bags, Baxter VIAFLEX Bags, and Smiths Medical Cassettes. The product is compounded by PharMEDium Services, LLC in Memphis, TN, and is 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 source text does not report any specific illnesses or injuries associated with the use of these products.

Healthcare providers and facilities that have received these products should stop using them and contact PharMEDium Services, LLC for further instructions. Consumers should not use these products and should consult their healthcare provider if they have questions regarding the recall.

The recalled product

Product
0.0625% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, a) 250 mL Hospira LifeCare Bag (NDC 61553-197-50), b) 250 mL Hospira LifeCare Bag (NDC 61553-197-50), c) 150 mL Baxter Intravia Bag (NDC 61553-189-48), d) 250 mL Baxter VIAFLEX Bag ( NDC 61553-197-02), e) 250…
Manufacturer
Pharmedium Services, LLC
Category
Drug — Injectable Anesthetic
Hazard
Affected units
2,194

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 2H8197
  • Lot Number 160730048M
  • Exp. Date 6/12/2016
  • Lot Number 160840111M
  • Exp. Date 6/22/2016
  • Lot Number 160870066M
  • Exp. Date 6/25/2016
  • Lot Number 160880208M
  • Exp. Date 6/27/2016
  • Lot Number 160910038M
  • Exp. Date 6/29/2016
  • Service Code 2K8189
  • Lot Number 160730049M
  • Exp. Date 6/11/2016
  • Lot Number 160810152M
  • Exp. Date 6/20/2016
  • Lot Number 160820330M
  • Exp. Date 6/21/2016
  • Lot Number 160940135M
  • Exp. Date 7/3/2016

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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