The Recall Desk
SevereFDA (Drugs)·D-1360-2016·Announced 2016-07-27

Pharmedium Recalls Bupivacaine HCl Due to Glass Particulate Contamination

Pharmedium Services, LLC is recalling 177 cassettes of 0.03% Bupivacaine HCl 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 hazard involves particulate matter in a sterile injectable drug, which poses a significant risk of injury.

Plain-English summary

Pharmedium Services, LLC is recalling 177 medical cassettes of 0.03% Bupivacaine HCl (Preservative Free) in Sodium Chloride 0.9%, 250 mL. The product is prescription-only and was compounded by Pharmedium Services, LLC in Memphis, TN. The recall covers specific lots with expiration dates of 05/16 and 06/16, and the product was distributed nationwide.

The recall was initiated because the active pharmaceutical ingredient (API) used to produce the sterile injectable drugs was contaminated with glass particulate matter. The presence of particulate matter in a sterile injectable drug presents a risk to patients.

Healthcare providers and patients should stop using the affected lots of Bupivacaine HCl and contact Pharmedium Services, LLC for further instructions or a return.

The recalled product

Product
0.03% Bupivacaine HCl (Preservative Free) in Sodium Chloride 0.9%, 250 mL Medical Cassette Reservoir, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-931-11
Manufacturer
Pharmedium Services, LLC
Category
Drug — Injectable
Hazard
Affected units
177

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 (11)

  • Lot # 160410097M
  • Exp. 05/16 Lot # 160420107M
  • Exp. 05/16 Lot # 160460117M
  • Exp. 05/16 Lot # 160530133M
  • Exp. 05/16 Lot # 160540206M
  • Exp. 05/16 Lot # 160570008M
  • Exp. 05/16 Lot # 160670132M
  • Exp. 06/16 Lot # 160700001C
  • Exp. 06/16 Lot # 160770020C
  • Exp. 06/16 Lot # 160900103C
  • Exp. 06/16

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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