The Recall Desk
SevereFDA (Drugs)·D-1367-2016·Announced 2016-07-27

PharMEDium Recalls Bupivacaine HCl Due to Glass Particulate Contamination

PharMEDium Services, LLC is recalling 355 bags of 0.2% Bupivacaine HCl sterile injectable drugs because the active ingredient was contaminated with 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 the presence of glass particulate matter in sterile injectable drugs poses a significant risk of serious injury, meeting the criteria for a Severe rating.

Plain-English summary

PharMEDium Services, LLC is recalling 355 bags of 0.2% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride. The recall involves various package sizes, including 400 mL, 250 mL, and 150 mL Baxter Intravia Bags, as well as 250 mL Yellow Smiths Medical Cassettes. The products were compounded by PharMEDium Services, LLC in Memphis, TN, and distributed nationwide.

The recall was initiated because the active pharmaceutical ingredient (API) used to produce these sterile injectable drugs was contaminated with glass particulate matter. The source text does not specify the number of reported illnesses or injuries associated with this contamination.

Healthcare facilities and consumers should stop using the affected lots immediately. The specific lot numbers and expiration dates are listed in the recall documentation. Users should contact PharMEDium Services, LLC for further instructions on returning or disposing of the product.

The recalled product

Product
0.2% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 400 mL in 500 mL Baxter Intravia Bag , Service Code 2K8119 (NDC 61553-119-09), 250 mL in 250 mL Baxter Intravia Bag, Service Code 2K8171(NDC 61553-171-37)150 mL in 150 mL Baxter Intravia Bag, Service Code 2K8463 (
Manufacturer
Pharmedium Services, LLC
Category
Drug — Sterile Injectable
Hazard
Affected units
355

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 2K8119
  • Lot Number 160480208M
  • Exp. Date 5/18/2016
  • Lot Number 160490134M
  • Exp. Date 5/19/2016
  • Lot Number 160520129M
  • Exp. Date 5/22/2016
  • Lot Number 160530167M
  • Exp. Date 5/23/2016
  • Lot Number 160700126M
  • Exp. Date 6/8/2016
  • Lot Number 160740148M
  • Exp. Date 6/13/2016
  • Lot Number 160750046M
  • Lot Number 160820124M
  • Exp. Date 6/21/2016
  • Service Code 2K8171
  • Lot Number 160880264M
  • Exp. Date 6/27/2016
  • Service Code 2K8217

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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