The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1386-2016·Announced 2016-07-27

PharMEDium Recalls Sterile Injectable Drugs Contaminated with Glass Particulate

PharMEDium Services, LLC is recalling 1,234 cassettes of sterile injectable drugs containing hydromorphone and bupivacaine due to the presence of 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 involves the injection of glass particulate matter into sterile drugs, which poses a significant risk of injury.

Plain-English summary

PharMEDium Services, LLC is recalling 1,234 cassettes of 10 mcg/mL HYDROmorphone HCl and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride. 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 products were distributed nationwide. The recall covers multiple lot numbers and service codes, including 2H8481, 2K8481, 2K8909, 2K8911, and 2T6481, with expiration dates ranging from May 2016 to July 2016.

Healthcare providers and consumers should stop using the recalled products immediately and contact PharMEDium Services, LLC for further instructions or to arrange for return of the product.

The recalled product

Product
10 mcg/mL HYDROmorphone HCl and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Yellow Smiths Medical Cassette (stop free-flow protection), Service Code 2K8909, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC…
Manufacturer
Pharmedium Services, LLC
Category
Drug — Sterile Injectable
Hazard
Affected units
1,234

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 2H8481
  • Lot Number 160460180M
  • Exp. Date 5/16/2016
  • Lot Number 160540181M
  • Exp. Date 5/24/2016
  • Lot Number 160830170M
  • Exp. Date 6/22/2016
  • Service Code 2K8481
  • Lot Number 160380110M
  • Exp. Date 5/8/2016
  • Lot Number 160390206M
  • Exp. Date 5/9/2016
  • Lot Number 160400241M
  • Exp. Date 5/10/2016
  • Lot Number 160410170M
  • Exp. Date 5/11/2016
  • Lot Number 160450130M
  • Exp. Date 5/15/2016
  • Lot Number 160480181M
  • Exp. Date 5/18/2016

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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