The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1387-2016·Announced 2016-07-27

PharMEDium Recalls Sterile Injectable Drugs Contaminated with Glass Particulate Matter

PharMEDium Services, LLC is recalling 1,277 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 involves a sterile injectable drug contaminated with glass particulate matter, which poses a significant risk of injury or adverse health consequences.

Plain-English summary

PharMEDium Services, LLC is recalling 1,277 bags of 10 mcg/mL HYDROmorphone HCl and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride. The product is a sterile injectable drug compounded in 250 mL Baxter Intravia Bags. The recall is being conducted because the active pharmaceutical ingredient (API) used to produce the drugs was contaminated with glass particulate matter.

The affected products were distributed nationwide. The recall includes multiple lot numbers and service codes, including 2K8482, 2K8908, and 2T6482, with expiration dates ranging from May 10, 2016, to July 17, 2016. The specific NDC for the product is 61553-908-02.

Consumers and healthcare providers should stop using the affected products immediately. The FDA classifies this recall as Class II, indicating that use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

The recalled product

Product
10 mcg/mL HYDROmorphone HCl and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride; 250 mL in 250 mL Baxter Intravia Bag, Service Code 2K8908, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-908-02 ,
Manufacturer
Pharmedium Services, LLC
Category
Drug — Sterile Injectable
Hazard
Affected units
1,277

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 2K8482
  • Lot Number 160400113M
  • Exp. Date 5/10/2016
  • Lot Number 160460097M
  • Exp. Date 5/16/2016
  • Lot Number 160470229M
  • Exp. Date 5/17/2016
  • Lot Number 160530109M
  • Exp. Date 5/23/2016
  • Lot Number 160630133M
  • Exp. Date 6/2/2016
  • Lot Number 160670166M
  • Exp. Date 6/6/2016
  • Lot Number 160680146M
  • Exp. Date 6/7/2016
  • Lot Number 160750150M
  • Exp. Date 6/14/2016
  • Lot Number 160810139M
  • Exp. Date 6/20/2016
  • Lot Number 160910246M

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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