PlainRecalls
FDA Drug Moderate Class II Terminated

fentaNYL Citrate 10 mcg per mL, 2,500 mcg per 250 mL, 250 mL in a LifeCare Bag, in Sodium Chloride 0.9%. Rx Only, PharMEDium Services, LLC 913 N. Davis Ave Cleveland, MS 36732 NDC 61553-113-50

Reported: April 15, 2020 Initiated: March 16, 2020 #D-1085-2020

Product Description

fentaNYL Citrate 10 mcg per mL, 2,500 mcg per 250 mL, 250 mL in a LifeCare Bag, in Sodium Chloride 0.9%. Rx Only, PharMEDium Services, LLC 913 N. Davis Ave Cleveland, MS 36732 NDC 61553-113-50

Reason for Recall

Firm is recalling 46 lots of various products because of a lack of sterility assurance.

Details

Recalling Firm
PharMEDium Services, LLC
Units Affected
210 units
Distribution
Distributed Nationwide in the US
Location
Dayton, NJ

Frequently Asked Questions

What product was recalled?
fentaNYL Citrate 10 mcg per mL, 2,500 mcg per 250 mL, 250 mL in a LifeCare Bag, in Sodium Chloride 0.9%. Rx Only, PharMEDium Services, LLC 913 N. Davis Ave Cleveland, MS 36732 NDC 61553-113-50. Recalled by PharMEDium Services, LLC. Units affected: 210 units.
Why was this product recalled?
Firm is recalling 46 lots of various products because of a lack of sterility assurance.
Which agency issued this recall?
This recall was issued by the FDA Drug on April 15, 2020. Severity: Moderate. Recall number: D-1085-2020.