The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1434-2016·Announced 2016-07-27

PharMEDium Recalls Sterile Injectable Drugs Contaminated with Glass Particulate Matter

PharMEDium Services is recalling 650 bags 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 the presence of glass particulate matter in sterile injectable drugs poses a significant risk of injury, meeting the criteria for a Severe rating.

Plain-English summary

PharMEDium Services, LLC is recalling 650 bags of 8 mcg/mL HYDROmorphone HCl and 0.05% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride. The product is compounded in 250 mL Hospira LifeCare Bags and is distributed nationwide. The recall involves specific lots with expiration dates ranging from May 9, 2016, to July 6, 2016.

The recall was initiated because the active pharmaceutical ingredient (API) used to produce these sterile injectable drugs was contaminated with glass particulate matter. The presence of particulate matter in sterile injectable products poses a risk to patient safety.

Healthcare providers and patients who have received or possess these specific lots should stop using the product and contact PharMEDium Services or their local FDA office for further instructions. The affected lots are identified by specific lot numbers and expiration dates listed in the official recall notice.

The recalled product

Product
8 mcg/mL HYDROmorphone HCl and 0.05% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Hospira LifeCare Bag, Service Code 2H9310, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-310-50
Manufacturer
Pharmedium Services, LLC
Category
Drug — Sterile Injectable
Hazard
Affected units
650

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)

  • Lot Number 160390094M
  • Exp. Date 5/9/2016
  • Lot Number 160450111M
  • Exp. Date 5/15/2016
  • Lot Number 160520101M
  • Exp. Date 5/22/2016
  • Lot Number 160550109M
  • Exp. Date 5/25/2016
  • Lot Number 160610124M
  • Exp. Date 5/31/2016
  • Lot Number 160620115M
  • Exp. Date 6/1/2016
  • Lot Number 160670036M
  • Exp. Date 6/5/2016
  • Lot Number 160680038M
  • Exp. Date 6/7/2016
  • Lot Number 160690110M
  • Lot Number 160740117M
  • Exp. Date 6/12/2016
  • Lot Number 160760109M

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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