The Recall Desk
SevereFDA (Drugs)·D-1384-2016·Announced 2016-07-27

PharMEDium Recalls Hydrocodone and Bupivacaine Syringes Due to Glass Particulates

PharMEDium Services, LLC is recalling 1,577 syringes of compounded hydrocodone and bupivacaine injectable drugs nationwide due to the presence of 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 FDA classified this recall as Class II. According to the rubric, FDA Class II recalls involving significant injury reports or structural defects are rated as Severe (4). While no specific injuries are reported in the text, the presence of glass particulates in a sterile injectable drug poses a significant risk of serious adverse health consequences, warranting a Severe rating under the Class II criteria.

Plain-English summary

PharMEDium Services, LLC is voluntarily recalling 1,577 syringes of compounded 10 mcg/mL HYDROmorphone HCl and 0.0625% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride. The affected products are distributed nationwide and are identified by specific service codes, lot numbers, and expiration dates listed in the recall notice.

The recall was initiated because the active pharmaceutical ingredient (API) used to produce these sterile injectable drugs was contaminated with glass particulate matter. The FDA has classified this recall as Class II, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

Healthcare providers and patients who have received or used these specific syringes should stop using them immediately. Consumers should contact their healthcare provider for further instructions and to determine if alternative treatment is necessary. The recall covers specific lots of Service Codes 2T6733, 2K8478, and 2T8478 with expiration dates ranging from May to July 2016.

The recalled product

Product
10 mcg/mL HYDROmorphone HCl and 0.0625% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 50 mL in 60 mL BD Syringe, Service Code 2T6733, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-733-20
Manufacturer
Pharmedium Services, LLC
Category
Drug — Injectable
Hazard
Affected units
1,577

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 2T6733
  • Lot Number 160560088M
  • Exp. Date 5/25/2016
  • Lot Number 160590097M
  • Exp. Date 5/28/2016
  • Lot Number 160610032M
  • Exp. Date 5/31/2016
  • Lot Number 160630191M
  • Exp. Date 6/2/2016
  • Lot Number 160740251M
  • Exp. Date 6/13/2016
  • Lot Number 160890051M
  • Exp. Date 6/27/2016
  • Lot Number 160910161M
  • Exp. Date 6/29/2016
  • Service Code 2K8478
  • Lot Number 160380039M
  • Exp. Date 5/8/2016
  • Lot Number 160410139M
  • Exp. Date 5/11/2016

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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