FDAClass IIOctober 19, 2016

fentaNYL Citrate Injection recall: Subpotent

fentaNYL Citrate Injection, 50 mcg per mL, Preservative Free, 1 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3153.

Why was fentaNYL Citrate Injection recalled?

Subpotent Drug and Stability Data Does Not Support Expiry: confirmed subpotency and potential loss of potency in drugs packaged and stored in syringes.

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 Numbers: 15100052M, 15103048M, 15104052M, 15118032M, 15127009M, 15127068M, 15134039M, 15135009M, 15135054M, 15140070M, 15147039M, 15148065M, 151900145M, 151930043M, Exp between 07/15/15-10/12/15

Product
fentaNYL Citrate Injection, 50 mcg per mL, Preservative Free, 1 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3153.
Recalling firm
Pharmedium Services, LLC
Quantity
4347 syringes
Distribution
Nationwide
Recall date
October 19, 2016
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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