The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1411-2016·Announced 2016-07-27

FDA Recalls Hydrocodone and Bupivacaine Cassettes Due to Glass Particulates

Pharmedium Services is recalling 212 cassettes of compounded hydrocodone and bupivacaine injectable solution 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 involves a sterile injectable drug contaminated with glass particulates, which poses a significant risk of injury or adverse health consequences, meeting the criteria for a Severe rating.

Plain-English summary

Pharmedium Services, LLC is recalling 212 medical cassettes of 20 mcg/mL HYDROmorphone HCl 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 product is distributed nationwide. The recall covers specific lots with expiration dates ranging from May 7, 2016, to June 24, 2016. The product is compounded by Pharmedium Services, LLC, located in Memphis, TN.

Healthcare providers and consumers should stop using the affected cassettes and contact Pharmedium Services, LLC for further instructions or a return. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
20 mcg/mL HYDROmorphone HCl and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 ml in 100 mL Yellow Smiths Medical Cassette, flow stop free-flow protection, Service Code 2T8216, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC…
Manufacturer
Pharmedium Services, LLC
Category
Drug — Injectable
Hazard
Affected units
212

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 (17)

  • Lot Number 160600315M
  • Exp. Date 5/7/2016
  • Lot Number 160670256M
  • Exp. Date 5/14/2016
  • Lot Number 160730057M
  • Exp. Date 5/20/2016
  • Lot Number 160740144M
  • Lot Number 160800152M
  • Exp. Date 5/27/2016
  • Lot Number 160900142M
  • Exp. Date 6/5/2016
  • Lot Number 160910123M
  • Exp. Date 6/6/2016
  • Lot Number 160940037M
  • Exp. Date 6/9/2016
  • Lot Number 161080048M
  • Exp. Date 6/24/2016

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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