FDAClass IIOctober 30, 2019

PF-Fentanyl Citrate 2 mcg/mL* & Bupivacaine HCl 0.125% recall: Contamination

PF-Fentanyl Citrate 2 mcg/mL* & Bupivacaine HCl 0.125% in 0.9% Sodium Chloride Injection-250 mL, Rx Only Total Dose: (500 mcg/312.5 mg)/250 mL…

Why was PF-Fentanyl Citrate 2 mcg/mL* & Bupivacaine HCl 0.125% 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?

Lots: FB9014A Exp. 12/09/2019; FB9017A Exp. 12/16/2019

Product
PF-Fentanyl Citrate 2 mcg/mL* & Bupivacaine HCl 0.125% in 0.9% Sodium Chloride Injection-250 mL, Rx Only Total Dose: (500 mcg/312.5 mg)/250 mL…
Recalling firm
Nephron Pharmaceuticals Corporation dba Nephron Sterile Compounding Center
Quantity
1370 bags
Distribution
Nationwide.
Recall date
October 30, 2019
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls