PharMEDium Recalls Sterile Injectable Drugs Contaminated with Glass Particulate
PharMEDium Services, LLC is recalling 1,234 cassettes of sterile injectable drugs containing hydromorphone and bupivacaine 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 recall is classified as FDA Class II and involves the injection of glass particulate matter into sterile drugs, which poses a significant risk of injury.
Plain-English summary
PharMEDium Services, LLC is recalling 1,234 cassettes of 10 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 products were distributed nationwide. The recall covers multiple lot numbers and service codes, including 2H8481, 2K8481, 2K8909, 2K8911, and 2T6481, with expiration dates ranging from May 2016 to July 2016.
Healthcare providers and consumers should stop using the recalled products immediately and contact PharMEDium Services, LLC for further instructions or to arrange for return of the product.
The recalled product
- Product
- 10 mcg/mL HYDROmorphone HCl and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Yellow Smiths Medical Cassette (stop free-flow protection), Service Code 2K8909, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-909-0
- Manufacturer
- Pharmedium Services, LLC
- Category
- Drug — Sterile Injectable
- Affected units
- 1,234
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 2H8481
- Lot Number 160460180M
- Exp. Date 5/16/2016
- Lot Number 160540181M
- Exp. Date 5/24/2016
- Lot Number 160830170M
- Exp. Date 6/22/2016
- Service Code 2K8481
- Lot Number 160380110M
- Exp. Date 5/8/2016
- Lot Number 160390206M
- Exp. Date 5/9/2016
- Lot Number 160400241M
- Exp. Date 5/10/2016
- Lot Number 160410170M
- Exp. Date 5/11/2016
- Lot Number 160450130M
- Exp. Date 5/15/2016
- Lot Number 160480181M
- Exp. Date 5/18/2016
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.
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