FDAClass IIAugust 2, 2023

FentaNYL 500 mcg/250 mL - Bupivacaine HCl 0.1% in 0.9% recall: CGMP Deviations

FentaNYL 500 mcg/250 mL - Bupivacaine HCl 0.1% in 0.9% Sodium Chloride 250mL Bag, Injection for Epidural Use (fentaNYL Concentration - 2 mcg/mL), Rx…

Why was FentaNYL 500 mcg/250 mL - Bupivacaine HCl 0.1% in 0.9% recalled?

cGMP deviations: due to shipment of rejected units.

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 # 1223047134, Use By: 09/21/2023

Product
FentaNYL 500 mcg/250 mL - Bupivacaine HCl 0.1% in 0.9% Sodium Chloride 250mL Bag, Injection for Epidural Use (fentaNYL Concentration - 2 mcg/mL), Rx…
Recalling firm
SCA Pharmaceuticals
Quantity
183 bags
Distribution
KY and NJ
Recall date
August 2, 2023
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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