The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1366-2016·Announced 2016-07-27

PharMEDium Recalls Bupivacaine HCl Cassettes Due to Glass Particulate

PharMEDium Services, LLC is recalling 315 cassettes of 0.15% 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. Per the rubric, an FDA Class II recall involving a sterile injectable drug contaminated with particulate matter (glass) is classified as Severe due to the potential for significant injury.

Plain-English summary

PharMEDium Services, LLC is recalling 315 medical cassettes of 0.15% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride. The product is a sterile injectable drug compounded in Memphis, Tennessee, and distributed nationwide. The recall involves multiple lot numbers with expiration dates ranging from May 7, 2016, to July 5, 2016.

The recall was initiated because the active pharmaceutical ingredient (API) used to produce the sterile injectable drugs was contaminated with glass particulate matter. The presence of particulate matter in a sterile injectable product poses a risk to patients who receive the medication.

Healthcare providers and patients should stop using the affected cassettes immediately. 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, or where the probability of serious adverse health consequences is remote.

The recalled product

Product
0.15% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Yellow Smiths Medical Cassette, flow stop free-flow protection, Service Code 2T8217, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-217-50
Manufacturer
Pharmedium Services, LLC
Category
Drug — Injectable Anesthetic
Hazard
Affected units
315

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)

  • Lot Number 160380121M
  • Exp. Date 5/7/2016
  • Lot Number 160420113M
  • Exp. Date 5/11/2016
  • Lot Number 160450116M
  • Exp. Date 5/15/2016
  • Lot Number 160470127M
  • Exp. Date 5/16/2016
  • Lot Number 160480136M
  • Exp. Date 5/18/2016
  • Lot Number 160490132M
  • Lot Number 160520114M
  • Exp. Date 5/21/2016
  • Lot Number 160530129M
  • Exp. Date 5/23/2016
  • Lot Number 160590138M
  • Exp. Date 5/29/2016
  • Lot Number 160600038C
  • Exp. Date 5/30/2016
  • Lot Number 160620018C

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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