FDAClass IIOctober 30, 2019

PF-Fentanyl Citrate 2 mcg/mL* & Ropivacaine HCl 0.1% in recall: Contamination

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…

Why was PF-Fentanyl Citrate 2 mcg/mL* & Ropivacaine HCl 0.1% in recalled?

GMP Deviations: potential glass contamination

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot: FR9002A Exp. 12/12/2019

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…
Recalling firm
Nephron Pharmaceuticals Corporation dba Nephron Sterile Compounding Center
Quantity
615 bags
Distribution
Nationwide.
Recall date
October 30, 2019
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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