PlainRecalls
FDA Drug Moderate Class II Terminated

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.

Reported: October 19, 2016 Initiated: July 17, 2015 #D-0034-2017

Product Description

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.

Reason for Recall

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

Details

Recalling Firm
Pharmedium Services, LLC
Units Affected
4347 syringes
Distribution
Nationwide
Location
Lake Forest, IL

Frequently Asked Questions

What product was recalled?
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.. Recalled by Pharmedium Services, LLC. Units affected: 4347 syringes.
Why was this product recalled?
Subpotent Drug and Stability Data Does Not Support Expiry: confirmed subpotency and potential loss of potency in drugs packaged and stored in syringes.
Which agency issued this recall?
This recall was issued by the FDA Drug on October 19, 2016. Severity: Moderate. Recall number: D-0034-2017.