PharMEDium Recalls Ropivacaine Cassettes Due to Sterility Assurance Failure
PharMEDium Services, LLC is recalling 21 cassettes of 0.2% Ropivacaine HCI due to a failure to follow proper testing procedures, raising concerns about sterility and endotoxin levels.
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 an epidural medication, which poses a significant risk of serious injury or hospitalization if contaminated.
Plain-English summary
PharMEDium Services, LLC is recalling 21 cassettes of 0.2% Ropivacaine HCI (Preservative Free) in 0.9 Sodium Chloride, Epidural, 250 mL Yellow Cassette. The recall involves Lot # 180030029D, which has an expiration date of 2/18/18.
The recall was initiated because three lots were released despite a failure to follow proper testing and investigation procedures. As a result, there is a lack of assurance of sterility, and the product may be out of specification for endotoxin.
The product was distributed to South Carolina, Florida, New York, and Washington. Healthcare providers and patients should stop using the affected product and contact PharMEDium Services, LLC for further instructions.
The recalled product
- Product
- 0.2% Ropivacaine HCI (Preservative Free) in 0.9 Sodium Chloride, Epidural, 250 mL Yellow Cassette, Rx only, PharMEDium Serivces, LLC
- Manufacturer
- PharMEDium Services, LLC
- Category
- Drug — Anesthetic
- Affected units
- 21
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 #: 180030029D
- Exp 2/18/18
Distribution
Part of a larger recall action
This product is one of 3 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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