The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1395-2016·Announced 2016-07-27

Pharmedium Recalls Fentanyl and Bupivacaine Bags Due to Glass Particulate

Pharmedium Services, LLC is recalling 43,589 bags of sterile injectable fentanyl and bupivacaine because the active ingredient was contaminated with 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 in a sterile injectable drug poses a significant risk of serious injury, meeting the criteria for a Severe rating.

Plain-English summary

Pharmedium Services, LLC is recalling 43,589 bags of 2 mcg/mL Fentanyl Citrate and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride. 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 products were distributed nationwide. The recall covers multiple service codes and lot numbers, with expiration dates ranging from May 2016 to July 2016. The products are compounded by PharMEDium Services, LLC in Memphis, TN.

Healthcare providers and patients should stop using the affected lots immediately. Consumers should check their medication packaging against the specific service codes and lot numbers listed in the official FDA recall notice to determine if their product is affected.

The recalled product

Product
2 mcg/mL Fentanyl Citrate and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Service Code 2C8201 , NDC 61553-201-58 , 200 ml in 250 ml Cormix Bag ; Service Code 2H8131 , NDC 61553-131-50 , 250 ml in 250 ml Hospira LifeCare Bag ; Service Code 2H8201 , NDC…
Manufacturer
Pharmedium Services, LLC
Category
Drug — Sterile Injectable
Hazard
Affected units
43,589

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 3V8701
  • Lot Number 160390095M
  • Exp. Date 5/9/2016
  • Lot Number 160480198M
  • Exp. Date 5/18/2016
  • Lot Number 160540108M
  • Exp. Date 5/24/2016
  • Lot Number 160690111M
  • Exp. Date 6/8/2016
  • Lot Number 160740250M
  • Exp. Date 6/13/2016
  • Lot Number 160820104M
  • Exp. Date 6/21/2016
  • Lot Number 160900119M
  • Exp. Date 6/28/2016
  • Lot Number 160970024M
  • Exp. Date 7/5/2016
  • Service Code 3V8703
  • Lot Number 160420127M
  • Exp. Date 5/6/2016

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

See all →

Same hazard · foreign object

See all →

Similar recalls