PlainRecalls
FDA Drug Moderate Class II Terminated

PHENYLephrine HCl, 100 mcg per mL, 0.5 mg per 5 mL, in 0.9% Sodium Chloride, Preservative Free, 5 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3346.

Reported: October 19, 2016 Initiated: July 17, 2015 #D-0087-2017

Product Description

PHENYLephrine HCl, 100 mcg per mL, 0.5 mg per 5 mL, in 0.9% Sodium Chloride, Preservative Free, 5 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3346.

Reason for Recall

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

Details

Recalling Firm
Pharmedium Services, LLC
Units Affected
2985 syringes
Distribution
Nationwide
Location
Lake Forest, IL

Frequently Asked Questions

What product was recalled?
PHENYLephrine HCl, 100 mcg per mL, 0.5 mg per 5 mL, in 0.9% Sodium Chloride, Preservative Free, 5 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3346.. Recalled by Pharmedium Services, LLC. Units affected: 2985 syringes.
Why was this product recalled?
Stability Data Does Not Support Expiry: 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-0087-2017.