The Recall Desk
SevereFDA (Drugs)·D-1383-2016·Announced 2016-07-27

Pharmedium Recalls Hydrocodone and Bupivacaine Bags Due to Glass Particulate

Pharmedium Services is recalling 55 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 poses a significant risk of injury.

Plain-English summary

Pharmedium Services, LLC is recalling 55 bags of 10 mcg/mL HYDROmorphone HCl and 0.0625% Bupivacaine HCl in 0.9% Sodium Chloride, 250 mL in 250 mL Baxter Intravia Bag. 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 product is prescription-only and was distributed nationwide. The recall covers five specific lot numbers with expiration dates ranging from May 17, 2016, to July 2, 2016. The product was compounded by Pharmedium Services, LLC in Memphis, TN.

Consumers and healthcare providers should discontinue use of the affected lots and contact their pharmacist or the recalling firm 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
10 mcg/mL HYDROmorphone HCl and 0.0625% Bupivacaine HCl in 0.9% Sodium Chloride, 250 mL in 250 mL Baxter Intravia Bag, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-733-17
Manufacturer
Pharmedium Services, LLC
Category
Drug — Sterile Injectable
Hazard
Affected units
55

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 (10)

  • Lot Number 160470116M
  • Exp. Date 5/17/2016
  • Lot Number 160490123M
  • Exp. Date 5/19/2016
  • Lot Number 160800048M
  • Exp. Date 6/18/2016
  • Lot Number 160890060M
  • Exp. Date 6/27/2016
  • Lot Number 160940050M
  • Exp. Date 7/2/2016

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 →

Related recalls

Same manufacturer · Pharmedium Services, LLC

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Same hazard · glass particulate

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