The Recall Desk
SevereFDA (Drugs)·D-1428-2016·Announced 2016-07-27

PharMEDium Recalls Sterile Injectable Drugs Contaminated with Glass Particulate Matter

PharMEDium Services, LLC is recalling 115 bags of compounded sterile injectable drugs containing hydromorphone and bupivacaine due to the presence of glass particulate matter.

What this means for you

Illness, injury, or structural failure has been reported. 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) in a sterile injectable drug, which meets the rubric criteria for a Severe rating due to the potential for significant injury.

Plain-English summary

PharMEDium Services, LLC is recalling 115 bags of 5 mcg/mL HYDROmorphone HCl and 0.0625% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride. The product is compounded in 250 mL Baxter Intravia Bags and is available by prescription only. 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 includes ten specific lot numbers with expiration dates ranging from May 8, 2016, to July 4, 2016. The specific lot numbers are 160380152M, 160400233M, 160540186M, 160660046M, 160730154M, 160750176M, 160760046M, 160800066M, 160820111M, and 160960039M.

Healthcare providers and patients should discontinue use of the affected lots and contact PharMEDium Services, LLC for further instructions. 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
5 mcg/mL HYDROmorphone HCl and 0.0625% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Baxter Intravia Bag, Service Code 2K8483, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-483-61
Manufacturer
Pharmedium Services, LLC
Category
Drug — Sterile Injectable
Hazard
Affected units
115

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 (19)

  • Lot Number 160380152M
  • Exp. Date 5/8/2016
  • Lot Number 160400233M
  • Exp. Date 5/10/2016
  • Lot Number 160540186M
  • Exp. Date 5/24/2016
  • Lot Number 160660046M
  • Exp. Date 6/4/2016
  • Lot Number 160730154M
  • Exp. Date 6/12/2016
  • Lot Number 160750176M
  • Exp. Date 6/14/2016
  • Lot Number 160760046M
  • Lot Number 160800066M
  • Exp. Date 6/18/2016
  • Lot Number 160820111M
  • Exp. Date 6/20/2016
  • Lot Number 160960039M
  • Exp. Date 7/4/2016

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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