SSM St. Clare Recalls Compounded Fentanyl and Ropivacaine Injectable Bags
SSM St. Clare Health Center is recalling compounded fentanyl and ropivacaine injectable bags due to a lack of sterility assurance. Microbial growth was detected during a routine simulation, though no distributed product was found to contain microorganisms.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a risk of harm (lack of sterility assurance) where injury has not yet been reported, as no distributed product was found to contain microorganisms.
Plain-English summary
SSM Health Care St. Louis DBA SSM St. Clare Health Center is recalling specific lots of Fentanyl 2 mcg/mL and ropivacaine 0.2% in 0.9% Sodium Chloride 150 mL bags. The product is a compounded injectable drug intended for prescription use in hospitals and offices. The affected lots are 170621-008, 170703-002, and 170711-031, with expiration dates ranging from September 19, 2017, to October 9, 2017.
The recall was initiated due to a lack of sterility assurance. Microbial growth was detected during a routine simulation of the manufacturing process. The source text explicitly states that no batches of distributed product have been identified as actually containing microorganisms.
The product was distributed to SSM Health entities in the state of Missouri only. Because this is a prescription injectable drug for hospital and office use, consumers are unlikely to possess this product directly. Healthcare facilities should discontinue use of the affected lots and contact the recalling firm for further instructions.
The recalled product
- Product
- Fentanyl 2 mcg/mL and ropivacaine 0.2% in 0.9% Sodium Chloride 150 mL, 150 mL bag, This is a compounded injectable drug; Rx only; Hospital/office use only. SSM St. Clare Outsourcing Facility, Fenton, MO. --- NDC: 88883-4272-01
- Category
- Drug — Compounded Injectable
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 (7)
- Lot
- exp: 170621-008
- 09/19/2017
- 170703-002
- 10/01/2017
- 170711-031
- 10/09/2017
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 10 recalled by SSM Health Care St. Louis DBA SSM St. Clare Health Center 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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