The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1368-2016·Announced 2016-07-27

PharMEDium Recalls Bupivacaine HCl Injectable Bags Due to Glass Particulates

PharMEDium Services, LLC is recalling 2,874 bags of 0.25% 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 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, which corresponds to a Severe severity score under the rubric. The presence of glass particulates in a sterile injectable drug poses a significant risk of injury, justifying the higher classification despite the lack of reported illnesses.

Plain-English summary

PharMEDium Services, LLC is recalling 2,874 bags of 0.25% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride. The recall involves multiple lot numbers and expiration dates ranging from May 2016 to July 2016. The affected products were distributed nationwide.

The recall was initiated because the active pharmaceutical ingredient (API) used to produce the sterile injectable drugs was contaminated with glass particulate matter. The source text does not report any illnesses or injuries associated with the use of these products.

Healthcare providers and patients should check their inventory for the specific lot numbers and expiration dates listed in the official recall notice. If the product is found, it should be quarantined and not administered. Consumers should contact their healthcare provider for further instructions regarding the disposal or return of the recalled medication.

The recalled product

Product
0.25% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride; , Service Code 2H8120 , NDC 61553-120-50 , 250 ml in 250 ml Hospira LifeCare Bag ; , Service Code 2H8243 , NDC 61553-243-54 , 200 ml in 250 ml Hospira LifeCare Bag ; , Service Code 2K8120 , NDC 61553-120-09…
Manufacturer
Pharmedium Services, LLC
Category
Drug — Injectable Anesthetic
Hazard
Affected units
2,874

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 2H8120
  • Lot Number 160380137M
  • Exp. Date 5/8/2016
  • Lot Number 160420181M
  • Exp. Date 5/12/2016
  • Lot Number 160450166M
  • Exp. Date 5/15/2016
  • Lot Number 160460209M
  • Exp. Date 5/16/2016
  • Lot Number 160600277M
  • Exp. Date 5/30/2016
  • Lot Number 160610057M
  • Lot Number 160610224M
  • Exp. Date 5/31/2016
  • Lot Number 160680153M
  • Exp. Date 6/7/2016
  • Lot Number 160810219M
  • Exp. Date 6/20/2016
  • Lot Number 160910124M
  • Exp. Date 6/29/2016

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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