PharMEDium Recalls Ropivacaine Cassettes Due to Sterility Concerns
PharMEDium Services is recalling 120 cassettes of Ropivacaine HCl 0.2% due to a reported sterility failure. The affected units were distributed to Virginia, Illinois, Pennsylvania, and Idaho.
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 lack of assurance of sterility in a medication, which poses a risk of significant injury or adverse health consequences.
Plain-English summary
PharMEDium Services, LLC is recalling 120 cassettes of Ropivacaine HCl 0.2% in 100 mL total volume in a 100 mL Yellow Cassette Res. Flowstop in Sodium Chloride 0.9%. The product is identified by NDC 61553-834-48, Lot # 151900249M, and an expiration date of 09/09/15.
The recall was initiated after the firm received a complaint regarding a sterility failure. This determination was made using a non-validated sterility test on a medication cassette. 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.
The affected product was distributed to Virginia, Illinois, Pennsylvania, and Idaho. Healthcare providers and patients should discontinue use of the affected cassettes and contact PharMEDium Services for further instructions or replacement.
The recalled product
- Product
- Ropivacaine HCl 0.2% in 100 mL total volume in a 100 mL Yellow Cassette Res. Flowstop in Sodium Chloride 0.9%, Rx Only, PharMEDium Services, LLC, 6100 Global Drive, Memphis, TN 38141, NDC 61553-834-48
- Manufacturer
- Pharmedium Services, LLC
- Category
- Drug — Injectable Medication
- Affected units
- 120
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 (2)
- Lot #: 151900249M
- Exp 09/09/15
Distribution
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