The Recall Desk
SevereFDA (Drugs)·D-1409-2016·Announced 2016-07-27

Pharmedium Recalls Hydrocodone and Bupivacaine Syringes Due to Glass Particulates

Pharmedium Services is recalling 435 syringes of compounded hydrocodone and bupivacaine due to glass particulate contamination.

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 involves glass particulate contamination in a sterile injectable drug, which poses a significant risk of injury or adverse health consequences.

Plain-English summary

Pharmedium Services, LLC is recalling 435 Monoject syringes of 20 mcg/mL HYDROmorphone HCl and 0.06% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride. The recall is due to the presence of particulate matter, specifically glass particulates, which contaminated the active pharmaceutical ingredient (API) used to produce the sterile injectable drugs.

The affected product is distributed nationwide. The recall covers specific lots with Service Codes 2K8157 and 2T6620, with expiration dates ranging from May 6, 2016, to July 3, 2016. The product is compounded by Pharmedium Services, LLC in Memphis, TN.

Consumers and healthcare providers should stop using the affected syringes and contact their healthcare provider or the recalling firm for further instructions. The FDA has classified this recall as Class II, indicating a reasonable probability that the use of the product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
20 mcg/mL HYDROmorphone HCl and 0.06% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride; 55 mL in 60 mL Monoject Syringe, Service Code 2T6620, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-620-12
Manufacturer
Pharmedium Services, LLC
Category
Drug — Injectable
Hazard
Affected units
435

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 2K8157
  • Lot Number 160420116M
  • Exp. Date 5/12/2016
  • Lot Number 160540135M
  • Exp. Date 5/24/2016
  • Lot Number 160630121M
  • Exp. Date 6/2/2016
  • Lot Number 160730218M
  • Exp. Date 6/12/2016
  • Lot Number 160760126M
  • Exp. Date 6/14/2016
  • Lot Number 160770152M
  • Exp. Date 6/16/2016
  • Lot Number 160810169M
  • Exp. Date 6/20/2016
  • Lot Number 160840206M
  • Exp. Date 6/23/2016
  • Lot Number 160940210M
  • Exp. Date 7/3/2016
  • Service Code 2T6620

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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