The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1410-2016·Announced 2016-07-27

Pharmedium Recalls Sterile Injectable Drugs Contaminated With Glass Particulate Matter

Pharmedium Services, LLC is recalling 25 bags of compounded 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 25 bags of 20 mcg/mL HYDROmorphone HCl and 0.075% Bupivacaine HCl (Preservative Free) 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 identified by NDC 61553-494-61 and Service Code 2K8494. The recall covers three specific lots: Lot Number 160530134M (Exp. Date 5/23/2016), Lot Number 160630039M (Exp. Date 6/1/2016), and Lot Number 160900044M (Exp. Date 6/28/2016). The source text indicates that the product was distributed nationwide.

Healthcare providers and patients should stop using the affected product 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
20 mcg/mL HYDROmorphone HCl and 0.075% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Baxter Intravia Bag, Service Code 2K8494, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-494-61
Manufacturer
Pharmedium Services, LLC
Category
Drug — Sterile Injectable
Hazard
Affected units
25

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 (6)

  • Lot Number 160530134M
  • Exp. Date 5/23/2016
  • Lot Number 160630039M
  • Exp. Date 6/1/2016
  • Lot Number 160900044M
  • Exp. Date 6/28/2016

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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