The Recall Desk
SevereFDA (Drugs)·D-1429-2016·Announced 2016-07-27

PharMEDium Recalls Sterile Injectable Drugs Contaminated with Glass Particulate

PharMEDium Services, LLC is recalling 445 bags of 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, which corresponds to a Severe rating under the rubric. The presence of glass particulate in sterile injectable drugs poses a significant risk of injury, including potential serious harm, even if specific injury reports are not detailed in the provided text.

Plain-English summary

PharMEDium Services, LLC is recalling 445 bags of 5 mcg/mL HYDROmorphone HCl and 0.075% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride. The affected products are packaged in 250 mL Hospira LifeCare Bags and 250 mL Baxter Intravia Bags. The recall is being conducted because the active pharmaceutical ingredient (API) used to produce these sterile injectable drugs was contaminated with glass particulate.

The recalled products are distributed nationwide. Specific lot numbers and expiration dates are listed in the source documentation, covering production dates from April 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 stop using the affected lots immediately. Consumers should contact their healthcare provider or pharmacist for guidance on alternative treatments or further instructions regarding the recalled medication.

The recalled product

Product
5 mcg/mL HYDROmorphone HCl and 0.075% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 ml Hospira LifeCare Bag, Service Code 2H8477 (NDC 61553-477-50), 250 mL in 250 mL Baxter Intravia Bag, Service Code 2K8477 (NDC 61553-477-61), Rx Only, Compounded by
Manufacturer
Pharmedium Services, LLC
Category
Drug — Sterile Injectable
Hazard
Affected units
445

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 2H8477
  • Lot Number 160400137M
  • Exp. Date 5/10/2016
  • Lot Number 160450131M
  • Exp. Date 5/15/2016
  • Lot Number 160470138M
  • Exp. Date 5/17/2016
  • Lot Number 160480132M
  • Exp. Date 5/18/2016
  • Lot Number 160550129M
  • Exp. Date 5/25/2016
  • Lot Number 160610059M
  • Exp. Date 5/30/2016
  • Lot Number 160620029M
  • Exp. Date 5/31/2016
  • Lot Number 160680044M
  • Exp. Date 6/6/2016
  • Lot Number 160750038M
  • Exp. Date 6/13/2016
  • Lot Number 160760128M

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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