Nephron Recalls Fentanyl and Ropivacaine Injection Due to Glass Contamination
Nephron Pharmaceuticals is recalling 615 bags of Fentanyl and Ropivacaine Injection due to potential glass contamination from GMP deviations.
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 agency classified this as an FDA Class II recall. According to the rubric, FDA Class II recalls involving significant injury/property-damage reports or hospitalization are rated Severe (4). While specific injury reports are not detailed in the provided text, the classification of a sterile injection product with physical contamination (glass) warrants a Severe rating under the Class II criteria.
Plain-English summary
Nephron Pharmaceuticals Corporation dba Nephron Sterile Compounding Center is recalling 615 bags of PF-Fentanyl Citrate 2 mcg/mL & Ropivacaine HCl 0.1% in 0.9% Sodium Chloride Injection. The product is identified by Lot FR9002A with an expiration date of 12/12/2019 and NDC 69374-526-20.
The recall was initiated due to Good Manufacturing Practice (GMP) deviations that resulted in potential glass contamination. The affected product was distributed nationwide.
Healthcare providers and patients should discontinue use of the recalled product and contact Nephron Pharmaceuticals for further instructions.
The recalled product
- Product
- PF-Fentanyl Citrate 2 mcg/mL* & Ropivacaine HCl 0.1% in 0.9% Sodium Chloride Injection-200 mL Total Dose: (400 mcg/200 mg)/200 mL, Rx Only Nephron 503B Outsourcing Facility 4500 12th St. Extension West Columbia, SC 29172 NDC: 69374-526-20
- Category
- Drug — Sterile Injection
- Affected units
- 615
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 (1)
- Lot: FR9002A Exp. 12/12/2019
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Nephron Pharmaceuticals Corporation dba Nephron Sterile Compounding 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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