0.2% Ropivacaine HCI (Preservative Free) in 0.9 Sodium Chloride, Epidural, 250 mL Yellow Cassette, Rx only, PharMEDium Serivces, LLC
Reported: February 21, 2018 Initiated: February 5, 2018 #D-0423-2018
Product Description
0.2% Ropivacaine HCI (Preservative Free) in 0.9 Sodium Chloride, Epidural, 250 mL Yellow Cassette, Rx only, PharMEDium Serivces, LLC
Reason for Recall
Lack of assurance of sterility: Three lots were released where there was a failure to follow proper testing and investigation procedures. Product may be out of specification (OOS) for endotoxin.
Details
- Recalling Firm
- PharMEDium Services, LLC
- Units Affected
- 21 Cassettes
- Distribution
- Product was distributed to SC, FL, NY, NY,WA
- Location
- Dayton, NJ
Frequently Asked Questions
What product was recalled? ▼
0.2% Ropivacaine HCI (Preservative Free) in 0.9 Sodium Chloride, Epidural, 250 mL Yellow Cassette, Rx only, PharMEDium Serivces, LLC. Recalled by PharMEDium Services, LLC. Units affected: 21 Cassettes.
Why was this product recalled? ▼
Lack of assurance of sterility: Three lots were released where there was a failure to follow proper testing and investigation procedures. Product may be out of specification (OOS) for endotoxin.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on February 21, 2018. Severity: Moderate. Recall number: D-0423-2018.
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