The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1372-2016·Announced 2016-07-27

PharMEDium Recalls Bupivacaine HCl Injectable Bags Due to Glass Particulate

PharMEDium Services, LLC is recalling 866 bags of 0.5% Bupivacaine HCl injectable solution because the active ingredient was contaminated with glass particulate.

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, which poses a risk of significant injury or adverse health consequences, meeting the criteria for a Severe rating.

Plain-English summary

PharMEDium Services, LLC is voluntarily recalling 866 bags of 0.5% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride. The affected products are available in 250 mL and 500 mL Baxter Intravia bags and were compounded in Memphis, Tennessee. The recall was initiated because the active pharmaceutical ingredient (API) used to produce these sterile injectable drugs was contaminated with glass particulate.

The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences. The affected lots were distributed nationwide. Specific lot numbers and expiration dates are listed in the recall documentation, covering products with expiration dates ranging from May 2016 to July 2016.

Healthcare providers and patients should discontinue use of the affected lots immediately. Patients who have received these products should contact their healthcare provider for guidance. The recall is limited to the specific service codes and lot numbers identified in the official FDA notice.

The recalled product

Product
0.5% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Baxter Intravia Bag, Service Code 2N1488 (NDC 61553-488-11), 500 mL in 500 mL Baxter Intravia Bag, Service Code 2N1489 (NDC 61553-489-01)Rx Only, Compounded by PharMEDium Services, LLC, Memphis…
Manufacturer
Pharmedium Services, LLC
Category
Drug — Injectable
Hazard
Affected units
866

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 2N1488
  • Lot Number 160520176M
  • Exp. Date 5/22/2016
  • Lot Number 160600059M
  • Exp. Date 5/30/2016
  • Lot Number 160970115M
  • Exp. Date 7/5/2016
  • Service Code 2N1489
  • Lot Number 160490027C
  • Exp. Date 5/19/2016
  • Lot Number 160560032C
  • Exp. Date 5/26/2016
  • Lot Number 160620024C
  • Exp. Date 6/1/2016
  • Lot Number 160630029C
  • Exp. Date 6/2/2016
  • Lot Number 160670059C
  • Exp. Date 6/6/2016
  • Lot Number 160700047C
  • Exp. Date 6/9/2016

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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