The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1412-2016·Announced 2016-07-27

PharMEDium Recalls Sterile Injectable Drugs Contaminated with Glass Particulate Matter

PharMEDium Services, LLC is recalling 555 sterile injectable drug cassettes containing Hydromorphone HCl and Bupivacaine HCl 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 a structural defect (glass particulate matter) in a sterile injectable drug, which poses a significant risk of injury or adverse health consequences, meeting the criteria for a Severe rating.

Plain-English summary

PharMEDium Services, LLC is recalling 555 medical cassettes of 20 mcg/mL HYDROmorphone HCl and 0.125% 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 specific lots identified by Service Codes 2K8158, 2K8495, 2K8913, 2K8947, 2K8986, and 2T6622, with expiration dates ranging from May 2016 to July 2016. The products are prescription-only (Rx Only) and were compounded by PharMEDium Services, LLC in Memphis, TN.

Healthcare providers and patients should discontinue use of the affected lots and contact PharMEDium Services, LLC for further instructions or returns. 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 recalled product

Product
20 mcg/mL HYDROmorphone HCl and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 100 mL Yellow Smiths Medical Cassette, Service Code 2K8947, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-947-48
Manufacturer
Pharmedium Services, LLC
Category
Drug — Sterile Injectable
Hazard
Affected units
555

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 2K8158
  • Lot Number 160380113M
  • Exp. Date 5/8/2016
  • Lot Number 160410115M
  • Exp. Date 5/11/2016
  • Lot Number 160420111M
  • Exp. Date 5/12/2016
  • Lot Number 160450184M
  • Exp. Date 5/15/2016
  • Lot Number 160520106M
  • Exp. Date 5/21/2016
  • Lot Number 160530143M
  • Exp. Date 5/23/2016
  • Lot Number 160550124M
  • Exp. Date 5/25/2016
  • Lot Number 160560211M
  • Exp. Date 5/26/2016
  • Lot Number 160600195M
  • Exp. Date 5/30/2016
  • Lot Number 160620137M

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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